Abiomed, Inc. · Temporary Left Heart Support Pump (Impella)
Total Reports
106
Reports (30d)
3
Active Signals
0
Open Recalls
35
What the reports describe · Claripulse analysis
Purge Cassette Recognition Failure
harm reported, automated impella, patient harm, purge cassette, cassette
21
reports
Purge System Failure Resolved by Exchange
purge pressure, aic, purge cassette, exchange, cassette
19
reports
Purge Solution Leak from Connection
purge pressure, implanted impella, purge cassette, patient implanted, cassette
10
reports
Cardiac Arrest During Catheterization
chest, laboratory, cardiac arrest, catheterization, arrest
1
reports
Access Site Hematoma Post-Transfer
pump placement, patient admitted, history shared, support year, shared
1
reports
Post-Implant Hematoma with Resuscitation
hematoma, manual, bleed, urine, resuscitation
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
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.
Oct 1, 2025 · Open, Classified
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
Sep 16, 2025 · Open, Classified
Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.
Aug 20, 2025 · Open, Classified
Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.
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