Abiomed
8 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Abiomed and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-06-03FDA-DeviceClass IAbiomed Impella Controller recalled for electrical and alignment faults
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.
- 2026-06-03FDA-DeviceClass IAbiomed Impella Controller recalled for hardware defects
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 potential for the Compact Flash Memory Card dislodgement due to external applied forces, which could result in AIC startup failures and data logging issues. Issue 3: Improper routing of the fan wire within the AIC could lead to fan wire damage, which may result in console boot-up failure. Issue 4: Potential capacitor related issues on the Power Battery Manager, including the potential for the capacitors to cause pump stop, purge stop, and/or single fan fuse failures.
- 2026-04-08FDA-DeviceClass ICheck your Impella Controller serial number
Potential that the "Purge System Blocked" alarm display on the Automated Impella Controller (AIC) could be delayed when using first generation Impella 5.5 (0550-0008*) pumps.
- 2026-04-08FDA-DeviceClass ICheck your Abiomed Impella pump cassette
Increased risk of purge leaks with Generation 1 purge cassettes.
- 2026-03-11FDA-DeviceClass IStop using affected Abiomed Impella RP devices
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
- 2026-03-11FDA-DeviceClass IStop using affected Abiomed Impella RP devices
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
- 2026-03-11FDA-DeviceClass IStop using Abiomed Impella RP devices
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
- 2026-01-14FDA-DeviceClass IICheck Abiomed Impella 5.5 packaging
Device packaged in incorrect outer box carton.
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