PURGE CASSETTE GEN 2, STERILE, NON QSK Adverse Events: FDA MAUDE Data
Abiomed, Inc. · Temporary Left Heart Support Pump (Impella)
Total Reports
100
Reports (30d)
4
Active Signals
1
Open Recalls
39
What the reports describe · Claripulse analysis
Most commonly reported problems
Placement Signal Not Reliable Alarm
scai, shock, stage, year old, year
13
reports
Cardiogenic Shock in Out-of-Hospital Arrest
scai, shock, cardiogenic, stage, cardiogenic shock
7
reports
Controller Failure to Read Purge Cassette
replacement, purge cassette, icu, remained, cassette
4
reports
Leak at Purge Connection Site
mechanical circulatory, artery, purge cassette, cassette, circulatory support
2
reports
False Aortic Alarm with Stable Position
position, aortic, placement signal, arterial, supported
1
reports
Pump Explanted with Hemolysis
site, hematoma, hemolysis, bleeding, explanted
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
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.
Feb 18, 2026 · Open, Classified
Increased risk of purge leaks with Generation 1 purge cassettes.
Feb 16, 2026 · Open, Classified
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.
Dec 4, 2025 · Open, Classified
Device packaged in incorrect outer box carton.
Evidence
Related research
Sharaf OM, et al. · Journal of surgical case reports · 2023
Satashia P, et al. · Perfusion · 2023
Coyan G, et al. · Medicina (Kaunas, Lithuania) · 2022
Van Edom C, et al. · European heart journal. Case reports · 2023
Szymanski TW, et al. · ASAIO journal (American Society for Artificial Internal Organs : 1992) · 2020
Citations indexed from PubMed.
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