DLP™
Cannula 77010 ART ONE Piece 10FR 5PK 17L
3manufacturers in China registered for this device type
804catalogue numbers in this listing
31510(k) clearances naming this product code
15recalls on this code
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
Record
| Listed by | Medtronic, Inc., United States |
|---|---|
| FDA product code | DWF |
| Device type | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4210 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K024069 |
| Record published | 2018-08-10 |
| Record revised | 2024-11-01 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment temperature up to 40 °C |
| Packaging | Pack of 10, pack of 20 |
| Sizes | Catheter gauge 3 to 51 Fr; outer diameter 1 to 6 mm; length 16 to 38.1 cm; needle gauge 13 to 16 G; outer diameter 0.64 to 0.95 cm; length 1.8 m |
| Distribution end date | 2026-01-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 77312 | Catheter Gauge 12.0 Fr | 5 | In distribution |
| 77010 | Catheter Gauge 10.0 Fr | 5 | In distribution |
| 77012 | Catheter Gauge 12.0 Fr | 5 | In distribution |
| 69322 | Catheter Gauge 22.0 Fr | 10 | In distribution |
| 69428 | Catheter Gauge 28.0 Fr | 10 | In distribution |
| CB67314 | Catheter Gauge 14.0 Fr | In distribution | |
| 12008 | Catheter Gauge 10.0 Fr | 20 | In distribution |
| 77116 | Catheter Gauge 16.0 Fr | 5 | In distribution |
| 30155 | Catheter Gauge 10.0 Fr | 10 | In distribution |
| CB80120 | Catheter Gauge 20.0 Fr | In distribution | |
| 12110 | Catheter Gauge 10.0 Fr | 20 | In distribution |
| CB66124 | Catheter Gauge 24.0 Fr | In distribution | |
| 75010 | Catheter Gauge 10.0 Fr | 20 | In distribution |
| 77208 | Catheter Gauge 8.0 Fr | 5 | In distribution |
| CB81122 | Catheter Gauge 22.0 Fr | In distribution | |
| 87220 | Catheter Gauge 20.0 Fr | 10 | In distribution |
| 70420 | Catheter Gauge 20.0 Fr | 20 | In distribution |
| 76120 | Catheter Gauge 20.0 Fr | 20 | In distribution |
| CB68128 | Catheter Gauge 28.0 Fr | In distribution | |
| CB77012 | Catheter Gauge 12.0 Fr | In distribution | |
| 94935 | Catheter Gauge 15.0 Fr | 10 | In distribution |
| CB68112 | Catheter Gauge 12.0 Fr | In distribution | |
| 10112 | Catheter Gauge 9.0 Fr | 20 | In distribution |
| 75008 | Catheter Gauge 8.0 Fr | 20 | In distribution |
| 66128 | Catheter Gauge 28.0 Fr | 10 | In distribution |
| 31002 | Outer Diameter 2.0 mm | 20 | In distribution |
| 77010 | Catheter Gauge 10.0 Fr | 5 | In distribution |
| 30001 | Outer Diameter 3.0 mm | 40 | In distribution |
| 68134 | Catheter Gauge 34.0 Fr | 10 | In distribution |
| 94965 | Catheter Gauge 15.0 Fr | 10 | In distribution |
| 70420 | Catheter Gauge 20.0 Fr | 20 | In distribution |
| 66116 | Catheter Gauge 16.0 Fr | 10 | In distribution |
| 94913L | Catheter Gauge 13.0 Fr | 10 | In distribution |
| 75320 | Catheter Gauge 20.0 Fr | 20 | In distribution |
| 94215T | Catheter Gauge 15.0 Fr | 10 | In distribution |
| 96328 | Catheter Gauge 28.0 Fr | 4 | In distribution |
| 67318 | Catheter Gauge 18.0 Fr | 10 | In distribution |
| 89120 | Catheter Gauge 20.0 Fr | 20 | In distribution |
| 68122 | Catheter Gauge 22.0 Fr | 10 | In distribution |
| CB66132 | Catheter Gauge 32.0 Fr | In distribution | |
| 67514 | Catheter Gauge 14.0 Fr | 10 | In distribution |
| 30005 | Outer Diameter 4.0 mm | 40 | In distribution |
| 89124 | Catheter Gauge 24.0 Fr | 20 | In distribution |
| 67514 | Catheter Gauge 14.0 Fr | 10 | In distribution |
| CB77010 | Catheter Gauge 10.0 Fr | In distribution | |
| CB77012 | Catheter Gauge 12.0 Fr | In distribution | |
| 30112 | Catheter Gauge 12.0 Fr | 10 | In distribution |
| 67528 | Catheter Gauge 28.0 Fr | 10 | In distribution |
| 87122 | Catheter Gauge 22.0 Fr | 10 | In distribution |
| 77016 | Catheter Gauge 16.0 Fr | 5 | In distribution |
| 84024 | Catheter Gauge 24.0 Fr | 20 | In distribution |
| 67530 | Catheter Gauge 30.0 Fr | 10 | In distribution |
| CB77014 | Catheter Gauge 14.0 Fr | In distribution | |
| CB69320 | Catheter Gauge 20.0 Fr | In distribution | |
| 87220 | Catheter Gauge 20.0 Fr | 10 | In distribution |
| CB68136 | Catheter Gauge 36.0 Fr | In distribution | |
| 71424 | Catheter Gauge 24.0 Fr | 20 | In distribution |
| 68114 | Catheter Gauge 14.0 Fr | 10 | In distribution |
| 12010 | Length 38.1 cm | 20 | In distribution |
| 67312 | Catheter Gauge 12.0 Fr | 10 | In distribution |
| 66236 | Catheter Gauge 36.0 Fr | 10 | In distribution |
| 66126 | Catheter Gauge 26.0 Fr | 10 | In distribution |
| 30320 | Catheter Gauge 20.0 Fr | 10 | In distribution |
| 68138 | Catheter Gauge 38.0 Fr | 10 | In distribution |
| 67314 | Catheter Gauge 14.0 Fr | 10 | In distribution |
| 12013 | Catheter Gauge 12.0 Fr | 20 | In distribution |
| 67518 | Catheter Gauge 18.0 Fr | 10 | In distribution |
| 77310 | Catheter Gauge 10.0 Fr | 5 | In distribution |
| 81120 | Catheter Gauge 20.0 Fr | 20 | In distribution |
| 12001 | Catheter Gauge 13.0 Fr | 20 | In distribution |
| 12113 | Catheter Gauge 13.0 Fr | 20 | In distribution |
| 67320 | Catheter Gauge 20.0 Fr | 10 | In distribution |
| 75324 | Catheter Gauge 24.0 Fr | 20 | In distribution |
| 87222 | Catheter Gauge 22.0 Fr | 10 | In distribution |
| 68126 | Catheter Gauge 26.0 Fr | 10 | In distribution |
| CB67532 | Catheter Gauge 32.0 Fr | In distribution | |
| 87224 | Catheter Gauge 24.0 Fr | 10 | In distribution |
| CB66118 | Catheter Gauge 18.0 Fr | In distribution | |
| 94975 | Catheter Gauge 15.0 Fr | 10 | In distribution |
| 30004 | Outer Diameter 2.0 mm | 40 | In distribution |
| 94913 | Catheter Gauge 13.0 Fr | 10 | In distribution |
| CB69328 | Catheter Gauge 28.0 Fr | In distribution | |
| 68124 | Catheter Gauge 24.0 Fr | 10 | In distribution |
| 77108 | Catheter Gauge 8.0 Fr | 5 | In distribution |
| 30014 | Catheter Gauge 14.0 Fr | 20 | In distribution |
| 66130 | Catheter Gauge 30.0 Fr | 10 | In distribution |
| 66118 | Catheter Gauge 18.0 Fr | 10 | In distribution |
| 77308 | Catheter Gauge 8.0 Fr | 5 | In distribution |
| 87020 | Catheter Gauge 20.0 Fr | 10 | In distribution |
| CB67312 | Catheter Gauge 12.0 Fr | In distribution | |
| 77110 | Catheter Gauge 10.0 Fr | 5 | In distribution |
| 10018 | Catheter Gauge 4.0 Fr | 20 | In distribution |
| 70422 | Catheter Gauge 22.0 Fr | 20 | In distribution |
| 20014 | Catheter Gauge 7.0 Fr | 20 | In distribution |
| 77112 | Catheter Gauge 12.0 Fr | 5 | In distribution |
| 83020 | Catheter Gauge 20.0 Fr | 20 | In distribution |
| 20012S | Catheter Gauge 9.0 Fr | 20 | In distribution |
| 12110 | Catheter Gauge 10.0 Fr | 20 | In distribution |
| CB68132 | Catheter Gauge 32.0 Fr | In distribution | |
| 69312 | Catheter Gauge 12.0 Fr | 10 | In distribution |
| CB77016 | Catheter Gauge 16.0 Fr | In distribution | |
| CB81120 | Catheter Gauge 20.0 Fr | In distribution | |
| 67636 | Catheter Gauge 36.0 Fr | 10 | In distribution |
| 67532 | Catheter Gauge 32.0 Fr | 10 | In distribution |
| 68122 | Catheter Gauge 22.0 Fr | 10 | In distribution |
| 20012 | Catheter Gauge 9.0 Fr | 20 | In distribution |
| 88022 | Catheter Gauge 22.0 Fr | 20 | In distribution |
| 68136 | Catheter Gauge 36.0 Fr | 10 | In distribution |
| 12008 | Catheter Gauge 10.0 Fr | 20 | In distribution |
| 67518 | Catheter Gauge 18.0 Fr | 10 | In distribution |
| 12113 | Catheter Gauge 13.0 Fr | 20 | In distribution |
| CB68124 | Catheter Gauge 24.0 Fr | In distribution | |
| 68118 | Catheter Gauge 18.0 Fr | 10 | In distribution |
| 67524 | Catheter Gauge 24.0 Fr | 10 | In distribution |
| 94915 | Catheter Gauge 15.0 Fr | 10 | In distribution |
| CB69320 | Catheter Gauge 20.0 Fr | In distribution | |
| 67312 | Catheter Gauge 12.0 Fr | 10 | In distribution |
| 10016 | Catheter Gauge 5.0 Fr | 20 | In distribution |
| 67522 | Catheter Gauge 22.0 Fr | 10 | In distribution |
| 69316 | Catheter Gauge 16.0 Fr | 10 | In distribution |
| 87122 | Catheter Gauge 22.0 Fr | 10 | In distribution |
| 69428 | Catheter Gauge 28.0 Fr | 10 | In distribution |
| CB67520 | Catheter Gauge 20.0 Fr | In distribution | |
| 77306 | Catheter Gauge 6.0 Fr | 5 | In distribution |
| CB67636 | Catheter Gauge 36.0 Fr | In distribution | |
| 77108 | Catheter Gauge 8.0 Fr | 5 | In distribution |
| 68118 | Catheter Gauge 18.0 Fr | 10 | In distribution |
| 10114 | Catheter Gauge 7.0 Fr | 20 | In distribution |
| 66120 | Catheter Gauge 20.0 Fr | 10 | In distribution |
| 77116 | Catheter Gauge 16.0 Fr | 5 | In distribution |
| CB67520 | Catheter Gauge 20.0 Fr | In distribution | |
| 87120 | Catheter Gauge 20.0 Fr | 10 | In distribution |
| CB68118 | Catheter Gauge 18.0 Fr | In distribution | |
| 87920 | Catheter Gauge 20.0 Fr | 10 | In distribution |
| 12006 | Needle Gauge 16.0 G | 20 | In distribution |
| CB71424 | Catheter Gauge 24.0 Fr | In distribution | |
| 67512 | Catheter Gauge 12.0 Fr | 10 | In distribution |
| 94945 | Catheter Gauge 15.0 Fr | 10 | In distribution |
| CB10012 | Catheter Gauge 9.0 Fr | In distribution | |
| 66116 | Catheter Gauge 16.0 Fr | 10 | In distribution |
| 11440 | 10 | In distribution | |
| 12218 | Catheter Gauge 4.0 Fr | 20 | In distribution |
| 66112 | Catheter Gauge 12.0 Fr | 10 | In distribution |
| 87120 | Catheter Gauge 20.0 Fr | 10 | In distribution |
| CB81122 | Catheter Gauge 22.0 Fr | In distribution | |
| 77212 | Catheter Gauge 12.0 Fr | 5 | In distribution |
| 30007 | Outer Diameter 3.0 mm | 40 | In distribution |
| 67516 | Catheter Gauge 16.0 Fr | 10 | In distribution |
| 94533 | Catheter Gauge 13.0 Fr | 10 | In distribution |
| 69528 | Catheter Gauge 28.0 Fr | 10 | In distribution |
| 30021 | Outer Diameter 3.0 mm | 40 | In distribution |
| 20114HWF | Catheter Gauge 7.0 Fr | 20 | In distribution |
| 77114 | Catheter Gauge 14.0 Fr | 5 | In distribution |
| 87022 | Catheter Gauge 22.0 Fr | 10 | In distribution |
| 68128 | Catheter Gauge 28.0 Fr | 10 | In distribution |
| 94745 | Catheter Gauge 15.0 Fr | 10 | In distribution |
| 10313 | Needle Gauge 13.0 G | 20 | In distribution |
| 57421 | Catheter Gauge 21.0 Fr | 4 | In distribution |
| 12115 | Catheter Gauge 15.0 Fr | 20 | In distribution |
| 77114 | Catheter Gauge 14.0 Fr | 5 | In distribution |
| 14007 | Length 38.1 cm | 10 | In distribution |
| 87924 | Catheter Gauge 24.0 Fr | 10 | In distribution |
| 50011 | Catheter Gauge 5.0 Fr | 10 | In distribution |
| CB67524 | Catheter Gauge 24.0 Fr | In distribution | |
| 67636 | Catheter Gauge 36.0 Fr | 10 | In distribution |
| 94535NPL | Catheter Gauge 15.0 Fr | 10 | In distribution |
| 94535 | Catheter Gauge 15.0 Fr | 10 | In distribution |
| CB75318 | Catheter Gauge 18.0 Fr | In distribution | |
| 68114 | Catheter Gauge 14.0 Fr | 10 | In distribution |
| 75014 | Catheter Gauge 14.0 Fr | 20 | In distribution |
| 71420 | Catheter Gauge 20.0 Fr | 20 | In distribution |
| 66140 | Catheter Gauge 40.0 Fr | 10 | In distribution |
| 68136 | Catheter Gauge 36.0 Fr | 10 | In distribution |
| 77006 | Catheter Gauge 6.0 Fr | 5 | In distribution |
| 12012 | Catheter Gauge 20.0 Fr | 20 | In distribution |
| 67524 | Catheter Gauge 24.0 Fr | 10 | In distribution |
| 12008 | Catheter Gauge 10.0 Fr | 20 | In distribution |
| 66114 | Catheter Gauge 14.0 Fr | 10 | In distribution |
| 94315T | Catheter Gauge 15.0 Fr | 10 | In distribution |
| CB67530 | Catheter Gauge 30.0 Fr | In distribution | |
| 66124 | Catheter Gauge 24.0 Fr | 10 | In distribution |
| 20114WF | Catheter Gauge 7.0 Fr | 20 | In distribution |
| 20114 | Catheter Gauge 7.0 Fr | 20 | In distribution |
| 94885 | Catheter Gauge 15.0 Fr | 10 | In distribution |
| 80022 | Catheter Gauge 22.0 Fr | 20 | In distribution |
| 10010 | 20 | In distribution | |
| CB12008 | Catheter Gauge 10.0 Fr | In distribution | |
| 66118 | Catheter Gauge 18.0 Fr | 10 | In distribution |
| 30006 | Outer Diameter 3.0 mm | 40 | In distribution |
| CB67534 | Catheter Gauge 34.0 Fr | In distribution | |
| 75012 | Catheter Gauge 12.0 Fr | 20 | In distribution |
| 69322 | Catheter Gauge 22.0 Fr | 10 | In distribution |
| 81122 | Catheter Gauge 22.0 Fr | 20 | In distribution |
| 69314 | Catheter Gauge 14.0 Fr | 10 | In distribution |
| 67314 | Catheter Gauge 14.0 Fr | 10 | In distribution |
| 30315 | Catheter Gauge 15.0 Fr | 10 | In distribution |
| 77310 | Catheter Gauge 10.0 Fr | 5 | In distribution |
| CB71424 | Catheter Gauge 24.0 Fr | In distribution | |
| 30022 | Outer Diameter 3.0 mm | 20 | In distribution |
| 66130 | Catheter Gauge 30.0 Fr | 10 | In distribution |
| 12001 | Catheter Gauge 13.0 Fr | 20 | In distribution |
| 14008 | Length 38.1 cm | 10 | In distribution |
| CB57421 | Catheter Gauge 21.0 Fr | In distribution | |
| 69528 | Catheter Gauge 28.0 Fr | 10 | In distribution |
| 77210 | Catheter Gauge 10.0 Fr | 5 | In distribution |
| CB68116 | Catheter Gauge 16.0 Fr | In distribution | |
| 94010 | Catheter Gauge 10.0 Fr | 4 | In distribution |
| 82022 | Catheter Gauge 22.0 Fr | 20 | In distribution |
| 67520 | Catheter Gauge 20.0 Fr | 10 | In distribution |
| 12001 | Catheter Gauge 13.0 Fr | 20 | In distribution |
| 77306 | Catheter Gauge 6.0 Fr | 5 | In distribution |
| 31001 | Outer Diameter 1.0 mm | 20 | In distribution |
| 94106 | Catheter Gauge 6.0 Fr | 4 | In distribution |
| 67320 | Catheter Gauge 20.0 Fr | 10 | In distribution |
| 67526 | Catheter Gauge 26.0 Fr | 10 | In distribution |
| 67316 | Catheter Gauge 16.0 Fr | 10 | In distribution |
| 89022 | Catheter Gauge 22.0 Fr | 20 | In distribution |
| 67638 | Catheter Gauge 38.0 Fr | 10 | In distribution |
| 88024 | Catheter Gauge 24.0 Fr | 20 | In distribution |
| 80020 | Catheter Gauge 20.0 Fr | 20 | In distribution |
| 87024 | Catheter Gauge 24.0 Fr | 10 | In distribution |
| 10010 | 20 | In distribution | |
| 57417 | Catheter Gauge 17.0 Fr | 4 | In distribution |
| 82020 | Catheter Gauge 20.0 Fr | 20 | In distribution |
| 66140 | Catheter Gauge 40.0 Fr | 10 | In distribution |
| 57414 | Catheter Gauge 14.0 Fr | 4 | In distribution |
| CB68118 | Catheter Gauge 18.0 Fr | In distribution | |
| 83024 | Catheter Gauge 24.0 Fr | 20 | In distribution |
| 76122 | Catheter Gauge 22.0 Fr | 20 | In distribution |
| 80322 | Catheter Gauge 22.0 Fr | 20 | In distribution |
| CB77006 | Catheter Gauge 6.0 Fr | In distribution | |
| 89122 | Catheter Gauge 22.0 Fr | 20 | In distribution |
| 77308 | Catheter Gauge 8.0 Fr | 5 | In distribution |
| 66112 | Catheter Gauge 12.0 Fr | 10 | In distribution |
| 68126 | Catheter Gauge 26.0 Fr | 10 | In distribution |
| 57417 | Catheter Gauge 17.0 Fr | 4 | In distribution |
| 80320 | Catheter Gauge 20.0 Fr | 20 | In distribution |
| 94995 | Catheter Gauge 15.0 Fr | 10 | In distribution |
| 77110 | Catheter Gauge 10.0 Fr | 5 | In distribution |
| CB66124 | Catheter Gauge 24.0 Fr | In distribution | |
| 69316 | Catheter Gauge 16.0 Fr | 10 | In distribution |
| CB68120 | Catheter Gauge 20.0 Fr | In distribution | |
| CB77016 | Catheter Gauge 16.0 Fr | In distribution | |
| 77208 | Catheter Gauge 8.0 Fr | 5 | In distribution |
| 31102 | Outer Diameter 2.0 mm | 20 | In distribution |
| 69312 | Catheter Gauge 12.0 Fr | 10 | In distribution |
| 12101 | Catheter Gauge 13.0 Fr | 20 | In distribution |
| 69331 | Catheter Gauge 31.0 Fr | 10 | In distribution |
| CB66128 | Catheter Gauge 28.0 Fr | In distribution | |
| CB66124 | Catheter Gauge 24.0 Fr | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Medtronic, Inc. | 5,237 |
| Bio-Medicus™ | Medtronic, Inc. | 223 |
| Pemco Inc | Pemco, Inc. | 137 |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Maquet Cardiopulmonary GmbH | 135 |
| Venous cardiopulmonary bypass cannula | LivaNova USA, Inc. | 97 |
| Eopa™ | Medtronic, Inc. | 87 |
| Surge Cardiovascular | MED Michigan Holdings LLC | 80 |
| Arterial cardiopulmonary bypass cannula | LivaNova USA, Inc. | 79 |
| MC2™ | Medtronic, Inc. | 66 |
| Select Series® | Medtronic, Inc. | 63 |
| Edwards Lifesciences Aortic Perfusion Cannula | Edwards Lifesciences Technology Sarl | 52 |
| PureFlex Arterial Cannulae | Sorin Group Italia SRL | 36 |
Showing 12 of 372. All products under Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260195 | 2026-04-23 |
| K253203 | 2026-02-19 |
| K253998 | 2026-01-20 |
| K251258 | 2025-06-20 |
| K231206 | 2023-12-07 |
| K230960 | 2023-05-04 |
| K201100 | 2021-07-15 |
| K190557 | 2019-04-03 |
| K182586 | 2018-10-19 |
| K180453 | 2018-03-22 |
| K180456 | 2018-03-22 |
| K171979 | 2017-10-27 |
| K171308 | 2017-06-02 |
| K153598 | 2016-01-15 |
| K151523 | 2015-07-16 |
| K150567 | 2015-04-09 |
| K143083 | 2015-03-25 |
| K150422 | 2015-03-20 |
| K143107 | 2015-01-07 |
| K142673 | 2014-11-18 |
| K141951 | 2014-08-15 |
| K140192 | 2014-05-22 |
| K140165 | 2014-05-20 |
| K132995 | 2013-10-31 |
| K131269 | 2013-07-10 |
| K123762 | 2013-03-27 |
| K122913 | 2012-10-19 |
| K120988 | 2012-07-25 |
| K120987 | 2012-06-06 |
| K120612 | 2012-05-25 |
| K100274 | 2010-05-10 |
Recalls Naming This Product
48 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Medtronic Perfusion Systems | 510(k) number | 2026-06-24 | Class II | Under Investigation by firm | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures. | 21,290 units | |
| Medtronic Perfusion Systems | 510(k) number | 2026-06-24 | Class II | Under Investigation by firm | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures. | 11,720 units | |
| Medtronic Perfusion Systems | 510(k) number | 2026-06-24 | Class II | Under Investigation by firm | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures. | 13,510 units | |
| Medtronic Perfusion Systems | 510(k) number | 2026-06-24 | Class II | Under Investigation by firm | Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures. | 3,110 units | |
| Medtronic Perfusion Systems | 510(k) number | 2026-05-25 | Class II | Packaging | Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. | ||
| Medtronic Perfusion Systems | 510(k) number | 2026-04-21 | Class II | Packaging process control | Certain lots of product have the potential for a sterile barrier breach. | 3790 units | |
| Medtronic Perfusion Systems | 510(k) number | 2026-04-21 | Class II | Packaging process control | Certain lots of product have the potential for a sterile barrier breach. | 6572 units | |
| Medtronic Perfusion Systems | 510(k) number | 2026-04-21 | Class II | Packaging process control | Certain lots of product have the potential for a sterile barrier breach. | 600 units | |
| Medtronic Perfusion Systems | 510(k) number | 2026-04-21 | Class II | Packaging process control | Certain lots of product have the potential for a sterile barrier breach. | 840 units | |
| Medtronic Perfusion Systems | 510(k) number | 2026-04-21 | Class II | Packaging process control | Certain lots of product have the potential for a sterile barrier breach. | 2620 units | |
| Medtronic Perfusion Systems | 510(k) number | 2026-04-21 | Class II | Packaging process control | Certain lots of product have the potential for a sterile barrier breach. | 3210 units | |
| Medtronic Perfusion Systems | 510(k) number | 2026-04-21 | Class II | Packaging process control | Certain lots of product have the potential for a sterile barrier breach. | 481 units | |
| Medtronic Perfusion Systems | 510(k) number | 2026-04-21 | Class II | Packaging process control | Certain lots of product have the potential for a sterile barrier breach. | 280 units | |
| Medtronic Perfusion Systems | 510(k) number | 2026-04-21 | Class II | Packaging process control | Certain lots of product have the potential for a sterile barrier breach. | 260 units | |
| Medtronic Perfusion Systems | 510(k) number | 2025-08-06 | Class I | Process change control | The catheters may not retain their shape. | 34549 units | |
| Medtronic Perfusion Systems | 510(k) number | 2025-08-06 | Class I | Process change control | The catheters may not retain their shape. | 41200 units | |
| Medtronic Perfusion Systems | 510(k) number | 2025-08-06 | Class I | Process change control | The catheters may not retain their shape. | 25261 units | |
| Medtronic Perfusion Systems | 510(k) number | 2024-12-12 | Class II | Packaging | Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. | 745 units | |
| Medtronic Perfusion Systems | 510(k) number | 2024-12-12 | Class II | Packaging | Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. | 930 units | |
| Medtronic Perfusion Systems | 510(k) number | 2024-12-12 | Class II | Packaging | Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae. | 440 units | |
| Medtronic Perfusion Systems | 510(k) number | 2024-10-03 | Class II | Process control | There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal | 420 units | |
| Medtronic Perfusion Systems | 510(k) number | 2024-07-09 | Class II | Under Investigation by firm | During manufacturing, DLP Single Stage Venous Cannulae – straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae – right angle metal tip (Model 67312). | 290 units | |
| Medtronic Perfusion Systems | 510(k) number | 2024-03-19 | Class II | Process control | Potential for unsealed sterile packing. | 13033 units | |
| Medtronic Perfusion Systems | 510(k) number | 2024-03-19 | Class II | Process control | Potential for unsealed sterile packing. | 250 units | |
| Medtronic Perfusion Systems | 510(k) number | 2024-03-19 | Class II | Process control | Potential for unsealed sterile packing. | 7935 units | |
| Medtronic Perfusion Systems | 510(k) number | 2024-03-19 | Class II | Process control | Potential for unsealed sterile packing. | 13954 units | |
| Medtronic Perfusion Systems | 510(k) number | 2024-03-19 | Class II | Process control | Potential for unsealed sterile packing. | 5719 units | |
| Medtronic Perfusion Systems | 510(k) number | 2024-03-19 | Class II | Process control | Potential for unsealed sterile packing. | 2622 units | |
| Medtronic Perfusion Systems | 510(k) number | 2024-03-19 | Class II | Process control | Potential for unsealed sterile packing. | 6290 units | |
| Medtronic Perfusion Systems | 510(k) number | 2024-03-19 | Class II | Process control | Potential for unsealed sterile packing. | 17221 units | |
| Medtronic Perfusion Systems | 510(k) number | 2024-02-07 | Class II | Packaging change control | Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above. | 4343 units | |
| Medtronic Perfusion Systems | 510(k) number | 2017-06-22 | Class II | Packaging process control | Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected. | 63053 (48180 US) (14873 OUS) | 2020-07-22 |
| Medtronic Perfusion Systems | 510(k) number | 2017-06-22 | Class II | Packaging process control | Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected. | 63053 (48180 US) (14873 OUS) | 2020-07-22 |
| Medtronic Perfusion Systems | 510(k) number | 2015-07-24 | Class II | Packaging process control | EOPA Arterial Cannula Devices in this lot were shipped without the guidewire. | 221 (111 US, 110 OUS) | 2016-04-04 |
| Medtronic Perfusion Systems | 510(k) number | 2015-06-12 | Class II | Nonconforming Material/Component | Medtronic is recalling select lots of DLP Femoral Arterial Cannula product due to recent reports in which the user had difficulty or was unable to connect the cannula to the perfusion circuit tubing. | 1304 devices | 2016-03-09 |
| Medtronic, Inc. | 510(k) number | 2013-02-19 | Class II | Nonconforming Material/Component | Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula. | 13,691 (6711 USA; 6980 OUS) | 2013-11-21 |
| Medtronic, Inc. | 510(k) number | 2011-12-14 | Not classified | Labeling design | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructi | 614,382 | 2014-05-22 |
| Medtronic, Inc. | 510(k) number | 2011-12-14 | Not classified | Labeling design | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructi | 336,171 | 2014-05-22 |
| Medtronic, Inc. | 510(k) number | 2011-12-14 | Not classified | Labeling design | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructi | 120,438 | 2014-05-22 |
| Medtronic, Inc. | 510(k) number | 2011-12-14 | Not classified | Labeling design | Instructions for Use for the DLP Single Stage Venous Cannulae are in the process of being updated. The current precaution statement referencing ventricular assist procedures will be identified as a contraindication in the updated Instructi | 139,777 | 2014-05-22 |
Showing 40 of 48.
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-01-30 | Class II | Under Investigation by firm | Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. | 19483 total (7669 US, 11814 OUS) | 2014-10-06 |
| 2014-01-30 | Class II | Under Investigation by firm | Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. | 19483 total (7669 US, 11814 OUS) | 2014-10-06 |
| 2014-01-30 | Class II | Under Investigation by firm | Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. | 19483 total (7669 US, 11814 OUS) | 2014-10-06 |
| 2014-01-30 | Class II | Under Investigation by firm | Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. | 19483 total (7669 US, 11814 OUS) | 2014-10-06 |
| 2014-01-30 | Class II | Under Investigation by firm | Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar. | 19483 total (7669 US, 11814 OUS) | 2014-10-06 |
| 2013-07-17 | Class II | Process control | Medtronic was notified that Edwards Lifesciences has initiated a product recall for the Rigid Suction Wand, model S099B. The Wands are included within certain Perfusion Tubing Packs that are manufactured and distributed by Medtronic. | 758 | 2014-02-04 |
| 2012-11-19 | Class II | Package design/selection | Medtronic is initiating an Urgent Medical Device Customer Notification. We have confirmed that certain Medtronic Intersept Tubing Packs contain packaging trays that are susceptible to damage that can compromise product sterility. | 1552 | 2013-04-04 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.