PUMP 381 PUMP SET (US) Adverse Events: FDA MAUDE Data

Aug 12, 2026 · Open, Classified

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

Aug 12, 2026 · Open, Classified

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

Aug 12, 2026 · Open, Classified

The potential for purge cassette recognition issues due to the failure of the purge flag component of the purge pressure sensor assembly.

May 18, 2026 · Open, Classified

Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.

May 14, 2026 · Open, Classified

Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.

Apr 20, 2026 · Open, Classified

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.