PURGE CASSETTE GEN 2, STERILE, NON QSK Adverse Events: FDA MAUDE Data
Abiomed, Inc. · Temporary Left Heart Support Pump (Impella)
Total Reports
126
Reports (30d)
8
Active Signals
0
Open Recalls
43
What the reports describe · Claripulse analysis
Most commonly reported problems
Controller Error During Clinical Use
complainant reported, automated impella, purge, aic, impella controller
6
reports
Cardiac Arrest During Support
purge, scai, shock, stage, prior
2
reports
Thrombus Identified During Support
scai, artery, shock, stage, femoral
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
FDA recalls for this device
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.
Evidence
Related research
Pietrasik A, et al. · ESC heart failure · 2023
Van Edom C, et al. · European heart journal. Case reports · 2023
Borrelli G, et al. · Perfusion · 2024
Choi MS, et al. · International journal of heart failure · 2020
Citations indexed from PubMed.
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