Recall Z-3146-2026 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Maquet Cardiopulmonary Gmbh
Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);
| Date | Sep 11, 2026 (initiated Jul 31, 2026) |
| Status | Open, Classified |
| Reason | The packaging may not consistently maintain sterile barrier integrity. |
| Root cause | Packaging |
| Action | On July 31, 2026 URGENT MEDICAL DEVICE REMOVAL letters were sent to customers. Customer Actions: 1. Ensure all affected, unused product in your inventory has been properly quarantined. 2. Please ensure this message is forwarded to any individuals that need notification within your organization or any organization where the affected devices have been transferred. 3. Contact Customer Service via email at customersupport.us@getinge.com or 888-943-8872, option 2 / (888 9GETUSA), Monday through Friday, between the hours of 8:00 a.m. and 5:00 p.m. (Eastern Time Zone) to return your unused, unexpir |
| Quantity | 16697 units (492 USA, 16205 OUS) |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Singapore, South |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131666 | ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING Maquet Cardiopulmonary, AG, Jul 5, 2013 |