Recall Z-2360-2026 ยท OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Abiomed, Inc.
Automated Impella Controller (AIC), for use with left heart support blood pump. Labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, AU; Product Code: 0042-0000-AU. 2. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 3. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 4. Impella Controller, Packaged, IN; Product Code: 0042-00
| Date | Jun 12, 2026 (initiated May 14, 2026) |
| Status | Open, Classified |
| Reason | Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices. |
| Root cause | Under Investigation by firm |
| Action | Abiomed notified consignees on about 05/14/2026 via letter titled "URGENT MEDICAL DEVICE RECALL (CORRECTION)." Consignees were made aware of the issue and potential risk and were informed that devices were not being removed, and hospital inventory can continue to be used. Specific, outlined scenarios were explained and that if they were to occur, that a console exchange is unnecessary as the phenomenon will recur on the exchange device. Abiomed is actively working on a software update to the AIC to address this issue. Consignees were instructed to complete and return the provided business rep |
| Quantity | 10,297 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Brunei, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.