Recall Z-0440-2023 ยท DSP System, Balloon, Intra-Aortic And Control
ARROW INTERNATIONAL Inc.
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac pump
| Date | Dec 15, 2022 (initiated Oct 17, 2022) |
| Status | Open, Classified |
| Reason | There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. |
| Root cause | Pending |
| Action | The firm issued an URGENT MEDICAL DEVICE NOTIFICATION to its consignees on 10/17/2022 by FedEx 2-day mail. To reduce the risk of short battery run time: .Plug IABP into an AC outlet during patient use, and when not in use. .Ensure the battery is fully charged prior to transporting patients, and a fully charged backup IABP device is available. .Replace the batteries when Battery Run Time is less than 90 minutes, there is visual damage to the battery, or Battery has been in service for 3 years. . Perform Battery Load Test at least every 12 months by qualified service personnel. If t |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201112 | AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP Arrow International, Inc., May 27, 2020 |