Recall Z-0440-2024 ยท OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Abiomed, Inc.
Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
| Date | Dec 1, 2023 (initiated Oct 10, 2023) |
| Status | Terminated |
| Reason | Pump not detected as connected to controller due to software issue. |
| Root cause | Software design |
| Action | An Urgent Medical Device Correction was issued vail mail October 24. 2023. Customers are advised to examine inventory for product running AIC software version: V8.4 or V8.4.1. Do not to use the product unless software is updated. Contact adminsfs@abiomed.com to schedule the software update and return the business reply form. Forward this information to relevant personnel and any facility product may have been transferred to. |
| Distribution | US: AZ, CA, FL, NY & VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.