Prime Set
Catalogue number AX-xxxxx, listed by LivaNova USA, Inc., United States, under Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
40recalls 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 | LivaNova USA, 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 | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K881330 |
| Record published | 2015-09-22 |
| Record revised | 2022-12-08 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AX-xxxxx | 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 |
|---|---|
| K250937 | 2026-03-11 |
| K250283 | 2025-07-10 |
Recalls Naming This Product
41 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 |
|---|---|---|---|---|---|---|---|
| LivaNova USA, Inc. | 510(k) number | 2018-11-09 | Class II | Process control | 4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours, may leak or be occluded. | 483 | 2022-05-03 |
| LivaNova USA, Inc. | 510(k) number | 2016-01-19 | Class III | Component design/selection | The CDI System 500 monitor displays the “H/S DISCONNECT AT CUVETTE” error message when the CDI HIS Cuvette does not make a proper connection with the CDI H/S Probe. When this occurs, blood parameter values for HCT, Hgb and S02 do not displa | 6859 | 2016-10-24 |
| LivaNova USA, Inc. | 510(k) number | 2013-07-08 | Class II | Material/Component Contamination | Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch. | 18,927 packs | 2014-01-28 |
| LivaNova USA, Inc. | 510(k) number | 2010-10-07 | Not classified | Packaging process control | Defective product packaging may compromise product sterility. | 72 | 2010-12-17 |
| LivaNova USA, Inc. | 510(k) number | 2010-10-07 | Not classified | Packaging process control | Defective product packaging may compromise product sterility. | 149 | 2010-12-17 |
| LivaNova USA, Inc. | 510(k) number | 2010-10-07 | Not classified | Packaging process control | Defective product packaging may compromise product sterility. | 79 | 2010-12-17 |
| LivaNova USA, Inc. | 510(k) number | 2010-10-07 | Not classified | Packaging process control | Defective product packaging may compromise product sterility. | 77 | 2010-12-17 |
| LivaNova USA, Inc. | 510(k) number | 2010-10-07 | Not classified | Packaging process control | Defective product packaging may compromise product sterility. | 10 | 2010-12-17 |
| LivaNova USA, Inc. | 510(k) number | 2010-10-07 | Not classified | Packaging process control | Defective product packaging may compromise product sterility. | 773 | 2010-12-17 |
| LivaNova USA, Inc. | 510(k) number | 2010-10-07 | Not classified | Packaging process control | Defective product packaging may compromise product sterility. | 79 | 2010-12-17 |
| LivaNova USA, Inc. | 510(k) number | 2010-10-07 | Not classified | Packaging process control | Defective product packaging may compromise product sterility. | 69 | 2010-12-17 |
| LivaNova USA, Inc. | 510(k) number | 2010-10-07 | Not classified | Packaging process control | Defective product packaging may compromise product sterility. | 77 | 2010-12-17 |
| LivaNova USA, Inc. | 510(k) number | 2010-10-07 | Not classified | Packaging process control | Defective product packaging may compromise product sterility. | 282 | 2010-12-17 |
| LivaNova USA, Inc. | 510(k) number | 2010-10-07 | Not classified | Packaging process control | Defective product packaging may compromise product sterility. | 1016 | 2010-12-17 |
| LivaNova USA, Inc. | 510(k) number | 2010-10-07 | Not classified | Packaging process control | Defective product packaging may compromise product sterility. | 86 | 2010-12-17 |
| LivaNova USA, Inc. | 510(k) number | 2010-10-07 | Not classified | Packaging process control | Defective product packaging may compromise product sterility. | 19 | 2010-12-17 |
| LivaNova USA, Inc. | 510(k) number | 2010-10-07 | Not classified | Packaging process control | Defective product packaging may compromise product sterility. | 8 | 2010-12-17 |
| LivaNova USA, Inc. | 510(k) number | 2010-10-07 | Not classified | Packaging process control | Defective product packaging may compromise product sterility. | 98 | 2010-12-17 |
| LivaNova USA, Inc. | 510(k) number | 2010-10-07 | Not classified | Packaging process control | Defective product packaging may compromise product sterility. | 16 | 2010-12-17 |
| LivaNova USA, Inc. | 510(k) number | 2010-10-07 | Not classified | Packaging process control | Defective product packaging may compromise product sterility. | 13 | 2010-12-17 |
| LivaNova USA, Inc. | 510(k) number | 2010-10-07 | Not classified | Packaging process control | Defective product packaging may compromise product sterility. | 54 | 2010-12-17 |
| LivaNova USA, Inc. | 510(k) number | 2010-10-07 | Not classified | Packaging process control | Defective product packaging may compromise product sterility. | 20 | 2010-12-17 |
| LivaNova USA, Inc. | 510(k) number | 2010-10-07 | Not classified | Packaging process control | Defective product packaging may compromise product sterility. | 18 | 2010-12-17 |
| LivaNova USA, Inc. | 510(k) number | 2010-10-07 | Not classified | Packaging process control | Defective product packaging may compromise product sterility. | 4 | 2010-12-17 |
| LivaNova USA, Inc. | 510(k) number | 2010-10-07 | Not classified | Packaging process control | Defective product packaging may compromise product sterility. | 2 | 2010-12-17 |
| LivaNova USA, Inc. | 510(k) number | 2009-12-30 | Not classified | Packaging process control | Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility. | 21 units | 2010-03-15 |
| LivaNova USA, Inc. | 510(k) number | 2009-12-30 | Not classified | Packaging process control | Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility. | 2 units | 2010-03-15 |
| LivaNova USA, Inc. | 510(k) number | 2009-12-30 | Not classified | Packaging process control | Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility. | 16 units | 2010-03-15 |
| LivaNova USA, Inc. | 510(k) number | 2009-12-30 | Not classified | Packaging process control | Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility. | 2 units | 2010-03-15 |
| LivaNova USA, Inc. | 510(k) number | 2009-12-30 | Not classified | Packaging process control | Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility. | 57 units | 2010-03-15 |
| LivaNova USA, Inc. | 510(k) number | 2009-12-30 | Not classified | Packaging process control | Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility. | 12 units | 2010-03-15 |
| LivaNova USA, Inc. | 510(k) number | 2009-12-30 | Not classified | Packaging process control | Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility. | 12 units | 2010-03-15 |
| LivaNova USA, Inc. | 510(k) number | 2009-12-30 | Not classified | Packaging process control | Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility. | 16 units | 2010-03-15 |
| LivaNova USA, Inc. | 510(k) number | 2009-12-30 | Not classified | Packaging process control | Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility. | 20 units | 2010-03-15 |
| LivaNova USA, Inc. | 510(k) number | 2009-12-30 | Not classified | Packaging process control | Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility. | 4 units | 2010-03-15 |
| LivaNova USA, Inc. | 510(k) number | 2009-12-30 | Not classified | Packaging process control | Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility. | 11 units | 2010-03-15 |
| LivaNova USA, Inc. | 510(k) number | 2009-12-30 | Not classified | Packaging process control | Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility. | 2 units | 2010-03-15 |
| LivaNova USA, Inc. | 510(k) number | 2009-12-30 | Not classified | Packaging process control | Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility. | 17 units | 2010-03-15 |
| LivaNova USA, Inc. | 510(k) number | 2009-12-30 | Not classified | Packaging process control | Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility. | 9 units | 2010-03-15 |
| LivaNova USA, Inc. | 510(k) number | 2009-12-30 | Not classified | Packaging process control | Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility. | 71 units | 2010-03-15 |
Showing 40 of 41.
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 |
|---|---|---|---|---|---|
| 2020-04-24 | Class II | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specif | 325 units | 2022-02-17 |
| 2020-04-24 | Class II | Packaging process control | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specif | 150 units | 2022-02-17 |
| 2017-09-28 | Class II | Process change control | A specific lot of the FlexFlowTM Venous Cannula, 200-200, is being recalled because it is sharper or pointier than expected. | 40 units | 2018-10-17 |
| 2017-06-09 | Class II | Process control | Identification of excess plastic on the tip of the cannula. | 105,770 units | 2023-11-09 |
| 2016-08-12 | Class II | Process control | The tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement. | 1205 units worldwide | 2017-03-27 |
| 2016-08-12 | Class II | Process control | Sorin Group USA, Inc. announces a voluntary field for the Aortic Arch Cannula and Coronary Artery Perfusion Cannula With Ballon because the tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned wher | 200 units worldwide | 2017-03-27 |
| 2016-06-22 | Class II | Process control | Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified. The defective cannula are showing an angle that is about 15-20 degrees instead of approximately 45 degr | 5740 | 2017-03-27 |
| 2016-01-25 | Class II | Employee error | Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case. | 60 | 2016-10-24 |
| 2010-06-18 | Not classified | PMA | Although accessories were designed for use with two models, the HLM C5 and the HLM S5, the submission that included references to the Mast Roller Pump, B-Care5, and the Electrical Venous Line Occluder accessories covered the new HLM S5 syst | 1 unit | 2010-07-21 |
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.