Recall Z-1953-2020 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Cardiac Assist, Inc
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
| Date | Mar 6, 2020 |
| Status | Terminated |
| Reason | Failure to prime due to an assembly error |
| Root cause | Under Investigation by firm |
| Action | LivaNova dba Tandem Life notified consignees via 1st class mail (certified return receipt) on March 06th, 2020, states reason for recall, health risk, and action to take: Check your inventory for the presence of potentially affected TandemHeart pump contained within your ordered kit as per Table 1 provided in Attachment 1; - Ensure any affected kit containing the potentially affected TandemHeart pump still in inventory gets quarantined before they can be returned. 2. Please fill and return Response Form by email to LivaNova.FSCA@livanova.comto confirm appropriate corrective actions have been |
| Quantity | 6 |
| Distribution | US Nationwide distributions. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110493 | TANDEMHEART PUMP Cardiacassist, Inc., Sep 20, 2011 |