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

Recall Summary Abiomed is recalling Impella Connect Optical AIC units, which are control interfaces used with heart pump catheters, due to multiple technical issues including problems recognizing equipment components, a sticky button that could limit operator control, potential console startup failures, and a software error affecting pressure calculations. The affected devices were distributed worldwide across the U.S., Canada, and numerous other countries. These issues may delay or impact heart support procedures.

Recalling firm: Abiomed, Inc.
Product: Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a 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/fd07082f-9ed2-4f61-9012-80f8c0a2d14e