Recall Z-3148-2026 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, IN; Product Code: 0042-0000-IN. 4. Impella Controller, Packaged, JP; Product Code: 0042-0000-JP. 5. Impella Controller, Packaged, UK;
| Date | Sep 16, 2026 (initiated Aug 12, 2026) |
| Status | Open, Classified |
| Reason | The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly. |
| Root cause | Under Investigation by firm |
| Action | On August 12, 2026 URGENT MEDICAL DEVICE RECALL (REMOVAL) letters were sent to customers. Actions to be Taken: 1. Hospital inventory can continue to be used while awaiting service from Abiomed to ensure continuity of care. 2. Abiomed s field service team will contact you to schedule the specified replacement. 3. In the event of these purge flag component failures and associated alarms, as per IFU, first reinsert purge disc to address the alarm. If that action does not clear the alarm, switch to a backup Automated Impella Controller. 4. Ensure cleaning of the AIC housing with mild detergent a |
| Quantity | 5232 units (3733 US, 1499 OUS) 36 3 |
| Distribution | Domestic: Nationwide Distribution. International: United Arab Emirates, Austria, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Croatia, Hungary, Ir |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.