Recall Z-0531-2015 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Medtronic Perfusion Systems
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated heat exchanger and arterial filter. The oxygenator is bonded on its primary blood contacting surfaces with a non-leaching biocompatible surface to reduce platelet activation and adhesion and preserve
| Date | Dec 16, 2014 (initiated Oct 31, 2014) |
| Status | Terminated |
| Reason | Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenation Systems with Carmeda Bioactive Surface due to damaged heat exchangers. Product affected by this issue is limited to model CB841 sold stand alone or incorporated in Total Systems TS1614R1 and TS1595R7. UPDATED: Recall was updated to incorporate three additional lots affected. |
| Root cause | Process control |
| Action | On October 31, 2014, Medtronic field representatives began verbally notifying consignees of the issue, requesting the quarantine and return of un-used, affected product. As a follow-up to these verbal notifications, on November 12, 2014, a Medtronic "Urgent Medical Device Recall" letter dated November 2014 was hand delivered by Medtronic field personnel, and was also sent to account risk managers via UPS. The letter described the problem, the product affected by the recall and actions to be taken. Consignees were asked to immediately quarantine, remove and return all affected product to Medtro |
| Quantity | 66, UPDATE: 168 additional devices. |
| Distribution | US Distribution to states of: CA and FL. UPDATED: OUS: Czech Republic and Switzerland. |
| FDA record | Open on fda.gov |