Abiomed, Inc.: Temporary Non-roller Type Left Heart Support Blood Pump
Recall Summary Abiomed is recalling Impella Optical Controller units used to operate Impella heart pumps due to multiple technical issues: an RFID firmware problem that may prevent the device from recognizing cassettes, a sticky button that could cause loss of console control, software instability that may prevent the pump from starting, and a calculator error affecting pressure readings. The recall affects units distributed nationwide in the U.S. and in numerous countries worldwide.
- Recalling firm
- Abiomed, Inc.
- Product
- Impella Optical Controller, 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/7f81923d-9dfa-4f0c-b450-2ef178713ec0