Z-0443-2023 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 21, 2022
- Initiation Date
- October 17, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump
Reason for Recall
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Distribution Pattern
Worldwide
Code Information
UDI/DI (01) 2 0801902 17207 9, (01) 2 0801902 17207 2, All Lot/Serial Numbers