Recall Z-0069-2026 ยท OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Abiomed, Inc.
Automated Impella Controller (AIC), used for 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, EU, Loaner; Product Code: 0042
| Date | Oct 9, 2025 (initiated Oct 1, 2025) |
| Status | Open, Classified |
| Reason | Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC). |
| Root cause | Software design |
| Action | Abiomed notified consignees via UPS delivery on about 10/01/2025. Consignees were informed of the potential cybersecurity vulnerabilities related to network and physical access. Next steps included that product was not being removed, to maintain the affected device in a secure environment with restricted access, and an Abiomed field representative will contact consignees to arrange disabling the AIC's network capabilities. Consignees were instructed to review the notice and forward it to applicable personnel or customers if further distributed, report any suspicions of a cybersecurity event, |
| Quantity | 10,153 units |
| Distribution | Nationwide distribution. International distribution to United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Colombia, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom of Great Britain and Northern Ireland, Greece, Hong Kong, Croatia, Ire |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.