Impella Adverse Events: FDA MAUDE Data

Abiomed, Inc. · Temporary Left Heart Support Pump (Impella) · First cleared Mar 2015 · 38 device variants grouped

Total Reports

38,616

Reports (30d)

1,566

Active Signals

Open Recalls

Monthly Report Volume

No timeline data available.

Event Type Breakdown

No event type data available.

Detection

Active safety signals

Disproportionate reportinghighDisproportionate reportinghighDisproportionate reportinghighVolume spikemediumIncreasing trendcriticalDisproportionate 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.

Evidence

Related research

Hemolysis associated with Impella heart pump positioning: In vitro hemolysis testing and computational fluid dynamics modeling

Nicholas J. Roberts, et al. · The International Journal of Artificial Organs · 2020

Short-Term Outcomes of Impella Support in Japanese Patients With Cardiogenic Shock Due to Acute Myocardial Infarction　― Japanese Registry for Percutaneous Ventricular Assist Device (J-PVAD) ―

Yuki Ikeda, et al. · Circulation Journal · 2023

Improved clinical outcomes associated with the Impella 5.5 compared to the Impella 5.0 in contemporary cardiogenic shock and heart failure patients

Danny Ramzy, et al. · The Journal of Heart and Lung Transplantation · 2023

Complications and Outcomes of Impella Treatment in Cardiogenic Shock Patients With and Without Acute Myocardial Infarction

Yuichi Saito, et al. · Journal of the American Heart Association · 2023

Impella and Venoarterial Extracorporeal Membrane Oxygenation in Cardiogenic Shock Complicating Acute Myocardial Infarction

Margriet Bogerd, et al. · European Journal of Heart Failure · 2023

Citations indexed from PubMed.

Keep exploring

Related devices in MCS

HVAD Pump Implant Kit

MEDTRONIC, INC. · 37,256 reports

→

HeartMate 3

Thoratec Corporation · 22,317 reports

→

HeartMate

Thoratec Corporation · 16,109 reports

→

CARDIOSAVE HYBRID, TYPE B PLUG

Datascope Corp. · 12,800 reports

→

THORATEC HEARTMATE, LVAS IMPLANT KIT (WITH SEALED GRAFTS)

Thoratec Corporation · 7,148 reports

→

ARROW IABP

TELEFLEX INCORPORATED · 4,724 reports

→

Want automated safety signal detection?

Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 25 active signals detected right now.

Get Early Access

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.

→

How a safety signal is detected

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

→

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.