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

Abiomed, Inc. · Temporary Left Heart Support Pump (Impella)

Total Reports

347

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Significant Hemolysis During Support

factors, scai, ami, urine, presenting

reports

Hematoma Development at Access Site

scai, hematoma, consistent, requirements, artery year

reports

Complications During Coronary Intervention

chest, coronary intervention, laboratory, catheterization, percutaneous coronary

reports

Vascular Compromise Leading to Limb Ischemia

factors, limb, scai, consistent, ischemia

reports

Hematoma at Insertion Site During Support

patient admitted, scai stage, scai, support year, presenting

reports

Death Following Pump Explantation

hemoglobin, hematoma, urine, resuscitation, death

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Detection

Active safety signals

Disproportionate reportinghigh

Regulatory

FDA recalls for this device

Class I

Feb 18, 2026 · Open, Classified

Increased risk of purge leaks with Generation 1 purge cassettes.

Class I

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.

Class II

Dec 4, 2025 · Open, Classified

Device packaged in incorrect outer box carton.

Class I

Oct 1, 2025 · Open, Classified

Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).

Class I

Sep 16, 2025 · Open, Classified

Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.

Class I

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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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.