Recall Z-2416-2020 ยท DSP System, Balloon, Intra-Aortic And Control
Arrow International Inc
Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/EMEA, Product Code IAP-0700
| Date | Jun 26, 2020 (initiated May 20, 2020) |
| Status | Terminated |
| Reason | A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP. |
| Root cause | Component design/selection |
| Action | Urgent Medical Device Correction notification letters dated 5/20/20 were sent to customers. ACTIONS TO BE TAKEN BY FACILITIES (Immediate): Please immediately check your inventory of Arrow AutoCAT2 and Arrow AC3 Optimus IABPs, whether stored or in use, and determine if you have an IABP with a model number listed above. Please see Appendix 1 for product codes and serial numbers. If an IABP in the scope of this Medical Device Correction displays a System Error 3 or High Baseline alarm, now or at any point in the future until the Long-Term Corrective Action detailed below occurs, immediately |
| Quantity | 2123 total |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162820 | AC3 Series IABP System Arrow International, Inc., Mar 31, 2017 |