Recall Z-2238-2026 ยท OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Abiomed, Inc.
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.
| Date | May 28, 2026 (initiated Jan 17, 2011) |
| Status | Open, Classified |
| Reason | Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console. |
| Root cause | Under Investigation by firm |
| Action | No customer notifications were sent. The retrospectively reported recall does not currently affect any Automated Impella Controllers (AICs) in the field pending the correction. The hardware update was implemented to AICs in the field through servicing to address potential safety concerns. |
| Quantity | 625 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Denmark, France, Germany, Italy, Kuwait, Netherlands, Norway, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.