Recall Z-0208-2027 ยท OZD Temporary Non-Roller Type Left Heart Support Blood Pump
Abiomed, Inc.
Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.
| Date | Oct 28, 2026 (initiated Sep 18, 2026) |
| Status | Open, Classified |
| Reason | Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may result in failure of the AIC to recognize the purge cassette during case setup or cassette change. This issue may result in delay in procedure or therapy. 2. Potential for the rotary push button (RPB) sticking and unreliable actuation impacting operator ability to select and confirm menu entries. This can result in loss of control of the console. 3. Potential AIC instability that could result in AIC start-up failure, inability to driv |
| Root cause | Under Investigation by firm |
| Action | Abiomed notified consignees on about 09/18/2026 via "URGENT MEDICAL DEVICE RECALL (REMOVAL)" letter. Consignees were informed of the issue and that affected units can continue to be used while awaiting service from Abiomed to ensure continuity of care. Consignees were instructed to identify if affected units are on hand, Abiomed will contact each consignee to coordinate the removal, update and return of affected devices, complete and return the provided business reply form by email to: Abiomed5510@sedgwick.com (or Fax to (866) 201-9339). If you have questions regarding returning this form, ple |
| Quantity | 428 units |
| Distribution | Worldwide Distribution: US (nationwide) and OUS (foreign) to countries: Belgium, Brazil, Canada, Colombia, Croatia, Czech Republic, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Kuwait, Luxembourg, Malaysia, Mexico, Netherlands, Norway, Pakistan, Panama, Poland, Saudi Arabia, Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.