Automated Impella Controller (AIC) labeled as the following with corresponding Product Codes: 1. AIC w/Impella Connect f
FDA device recall Z-0136-2026 · posted 2025-10-17 · Open, Classified
Recall details
- Recalling firm
- Abiomed, Inc.
- Reason for recall
- Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
- Action taken
- Abiomed 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 (https://www.heartrecovery.com/en-us/resources/downloads/field-safety-notification-aic-purge-retainer).
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- OZD
- Quantity affected
- 9,177 total distributed units (754 pending correction)
- Distribution
- Worldwide distribution. US Nationwide, Australia, Austria, Belgium, Brazil, Canada, Columbia, Croatia, Czechia, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Isreal, Italy, Japan, Kuwai
- Date initiated
- 2025-09-16
- Date posted
- 2025-10-17
- Location
- Danvers, MA
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