Device product
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump
Z-0443-2023
Product summary
- Event
- Event 91021
- Status
- Ongoing
- Classification
- Class I
- Quantity
- N/A
- Official record key
device-enforcement:Z-0443-2023
Official wording
Reason: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information: UDI/DI (01) 2 0801902 17207 9, (01) 2 0801902 17207 2, All Lot/Serial Numbers
Distribution pattern: Worldwide
Derived failure modes
-
Unknown
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.