ClearanceBrief
Recall Z-0136-2026 ยท OZD Temporary Non-Roller Type Left Heart Support Blood Pump

Abiomed, Inc.

Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect for ECP, Product Code: 1000432. 2. Dbl optical, AIC Impella Connect, Phg US, Product Code: 1000201. 3. Impella Controller, Packaged, AU, Product Code: 0042-0000-AU. 4. Impella Controller, Packaged, CA, Product Code: 0042-0000-CA. 5. Impella Controller, Packaged, EU, Product C

DateOct 17, 2025 (initiated Sep 16, 2025)
StatusOpen, Classified
ReasonPotential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
Root causeDevice Design
ActionAbiomed notified consignees on about 09/16/2025, via URGENT MEDICAL DEVICE RECALL (REMOVAL) letter. Consignees were instructed that hospital inventory can continue to be used to ensure continuity of care, upon contact from Abiomed's field servicing team, please work with them to return the identified device(s) for the change to be implemented, forward the recall notification to all affected personnel, notify customers if units were further distributed or transferred, and complete and return the provided response form. Additionally, the customer letter has been posted on heartrecovery.com (htt
Quantity9,177 total distributed units (754 pending correction)
DistributionWorldwide distribution. US Nationwide, Australia, Austria, Belgium, Brazil, Canada, Columbia, Croatia, Czechia, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Isreal, Italy, Japan, Kuwait, Luxembourg, Mexico, Netherlands, Pakistan, Panama, Poland, Saudi Arabia, Singapore, Spain, Sweden
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.