Recall Z-1192-2021 · DTN Reservoir, Blood, Cardiopulmonary Bypass
Medtronic Perfusion Systems
Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are co
| Date | Mar 17, 2021 (initiated Feb 4, 2021) |
| Status | Terminated |
| Reason | Products being recalled due to potentially elevated level of bacterial endotoxin. Patients exposed to elevated levels of bacterial endotoxins may develop an acute inflammatory response. |
| Root cause | Device Design |
| Action | A written Medical Device Correction letter will be mailed via UPS 2-day delivery to consignees who have received affected product according to Medtronic records. Consignees will be asked to complete the enclosed Customer Confirmation Form and email to rs.cfqfca@medtronic.com. Consignees will also be asked to return all unused affected product in your inventory to Medtronic. Contact Medtronic Customer Service at800-854-3570 to initiate a product return. |
| Quantity | 3 units |
| Distribution | Worldwide distribution: US nationwide, Afghanistan, Argentina, Chile, China, Colombia, Egypt, Germany, Iraq, Italy, Japan, Korea, Kyrgyzstan, Latvia, Nicaragua, Paraguay, Poland, Qatar, Romania, Tanzania, United Arab Emirates, United Kingdom, Uzbekistan, and Viet Nam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183511 | Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Res Medtronic, Inc., Mar 18, 2019 |