Recall Z-2211-2026 ยท OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Abiomed, Inc.
Automated Impella Controller (AIC); Product Code: 0042-0000-US;
| Date | May 22, 2026 (initiated Apr 20, 2026) |
| Status | Open, Classified |
| Reason | A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. Issue 2: There is a potentia |
| Root cause | Under Investigation by firm |
| Action | On April 20, 2026 URGENT MEDICAL DEVICE RECALL (REMOVAL) letters were sent to customers via 1-day direct mail (US). OUS notification process will be commensurate with local requirements. Actions to be taken: 1. For the devices identified, the Abiomed servicing team will contact you to coordinate the return of the device(s) to implement necessary changes. To ensure continuity of care, hospital inventory can continue to be used. 2. Upon contact from Abiomed s field servicing team, please work with them to return the identified device(s) for the change to be implemented. Refer to Attachment 2 fo |
| Quantity | 91 units |
| Distribution | Worldwide - US Nationwide distribution in the states of CA, CT, FL, LA, MA, MI, MO, MS, ND, NY, OH, PA, TX, WY and the countries of Brazil, Canada, Colombia, Hong Kong, Italy, Kuwait, Saudi Arabia, UAE, United Kingdom; |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.