Recall Z-2164-2025 ยท OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Abiomed, Inc.
Automated Impella Controller (AIC), used in left heart support blood pump, including the following: 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, EU, Loaner; Product Code: 0042-0000-EU-L. 5. Impella Controller,
| Date | Jul 26, 2025 (initiated Jun 23, 2025) |
| Status | Open, Classified |
| Reason | A potential issue with the Automated Impella Controller (AIC) not detecting an Impella pump when it is connected |
| Root cause | Device Design |
| Action | Initially Abiomed posted their recall notification on their website, HeartRecover.com on 06/23/2025. Consignees were also notified on 06/25/2025 via letter. Consignees were advised that devices were not being removed. They were advised to have a back-up Automated Impella Controller (AIC) available in the event of a device failure and were provided work around instruction for console-to-console transfer and case starts. Additionally, consignees were instructed to forward the notification to all pertinent personnel and customers if further distributed and complete and return the business respon |
| Quantity | 11,031 units |
| Distribution | Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brunei Darussalam, Canada, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Pakistan, Panama, Poland, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.