Abiomed, Inc.: Temporary Non-roller Type Left Heart Support Blood Pump

Recall Summary Abiomed is recalling certain Automated Impella Controller units used to operate heart pump devices. The controllers have multiple issues including problems recognizing equipment components, buttons that may stick, software crashes, and potential startup failures that could delay or interrupt patient procedures. The affected units were distributed worldwide, including throughout all U.S. states and territories, as well as 30 other countries.

Recalling firm: Abiomed, Inc.
Product: Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.
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...
Classification: Class III
Category: medical device recall
Country: United States
Agency: FDA-DEVICES
Recall date: 2026-09-18
Status: Open, Classified
Areas affected: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
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,...

Recall details on Nibble Recalls: https://trynibble.app/recalls/35bd3d5d-4756-4050-8712-012a4924aae9