Abiomed
5 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.
- 2026-04-08FDA-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.
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