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

Plain-English Summary Abiomed is recalling certain Automated Impella Controller units used to operate left heart support blood pumps due to four potential hardware issues: a cable that could cause the motor to stop working, a memory card that might come loose and prevent startup, a fan wire that could break and stop the console from booting, and capacitor problems that could halt the pump or cause fuse failures. The affected devices are distributed across the U.S. and internationally in countries including Canada, the United Kingdom, Brazil, and the Middle East. This is a Class III recall, meaning there is a potential for serious injury or death, but the company is addressing these issues through a servicing process for units that have not yet received the necessary hardware updates.

Recalling firm: Abiomed, Inc.
Product: Automated Impella Controller (AIC); Product Code: 0042-0000-US;
Reason: A retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware updates have been implemented through Abiomed s servicing process; therefore, AICs that have not received service are pending these updates. Issue 1: The proximity of the internal Video Graphics Array cable to the Digital Signal Processor chipset on the Impellatronic printed circuit assembly could potentially result in Electrostatic Discharge coupling into the Digital Signal Processor which may interrupt motor controls. Issue 2: There is a...
Classification: Class III
Category: medical device recall
Country: United States
Agency: FDA-DEVICES
Recall date: 2026-04-20
Status: Open, Classified
Areas affected: AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, LA, MA, MI, MO, MS, ND, NY, OH, PA, TX, WY and the countries of Brazil, Canada, Colombia, Hong Kong, Italy, Kuwait, Saudi Arabia, UAE, United Kingdom;

Recall details on Nibble Recalls: https://trynibble.app/recalls/5e1361f8-1553-4a33-83c0-d995881f5384