Affinity Fusion™
Affinity Fusion Recirculation Line provides a path between the recirculation port of the Affinity Fusion oxygenator and the venous reservoir. The line is used to connect tubing or devices…
Affinity Fusion Recirculation Line provides a path between the recirculation port of the Affinity Fusion oxygenator and the venous reservoir. The line is used to connect tubing or devices during cardiopulmonary bypass.
The filing describes a flexible line with a Y connector and female luer ports, intended for bypass procedures up to six hours. The listed RCL841 model is named in the product record.
Listed Item
Recir Line RCL841 FOR Fusion OXY/CVR
Device Description
The line is flexible and has a Y connector and female luer ports.
3manufacturers in China registered for this device type
1catalogue number
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) | K122913 |
| Record published | 2016-06-17 |
| Record revised | 2024-11-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment humidity 30 to 75 % RH; Storage environment temperature -30 to 50 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| RCL841 | 12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | Medtronic, Inc. | 5,237 |
| DLP™ | Medtronic, Inc. | 804 |
| 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 |
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
8 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 | 14,306 | 2014-05-22 |
| 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 |
| 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 | 883 | 2014-05-22 |
| 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 |
| 2004-09-15 | Not classified | Other | Spiral tip from DLP VAD cannula may be loose and potentially detach during use. | 753 units, 203 distributed in US to 24 customers. | 2005-11-03 |
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.