FDA Database
110,447 reports · 32 product codes · Updated weekly
44 results for “impella”
Abiomed, Inc.
Temporary Left Heart Support Pump (Impella)
Abiomed, Inc.
Temporary Left Heart Support Pump (Impella)
Abiomed, Inc.
Temporary Left Heart Support Pump (Impella)
ABIOMED EUROPE GMBH - 3007904765
Temporary Left Heart Support Pump (Impella)
ABIOMED EUROPE
Temporary Left Heart Support Pump (Impella)
IMPELLA CP
Temporary Left Heart Support Pump (Impella)
DANVERS, MA
Temporary Left Heart Support Pump (Impella)
ABIOMED EUROPE
Temporary Left Heart Support Pump (Impella)
Abiomed, Inc.
Temporary Left Heart Support Pump (Impella)
Abiomed, Inc.
Temporary Left Heart Support Pump (Impella)
UNKNOWN
Temporary Left Heart Support Pump (Impella)
ABIOMED EUROPE GMBH
Temporary Left Heart Support Pump (Impella)
DANVERS, MA
Temporary Left Heart Support Pump (Impella)
IMPELLA 5.5
Temporary Left Heart Support Pump (Impella)
ABIOMED EUROPE GMBH
Temporary Left Heart Support Pump (Impella)
ABIOMED EUROPE GMBH
Temporary Left Heart Support Pump (Impella)
Abiomed, Inc.
Temporary Left Heart Support Pump (Impella)
ABIOMED ,INC
Temporary Left Heart Support Pump (Impella)
AUTOMATED IMPELLA CONTROLLER
Temporary Left Heart Support Pump (Impella)
22 CHERRY HILL DR
Temporary Left Heart Support Pump (Impella)
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more.
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MAUDE (Manufacturer and User Facility Device Experience) is the FDA's public database of medical device adverse event reports submitted by manufacturers, importers, device user facilities, and the public. It is the most comprehensive public source of device safety reports in the United States.
Yes. This lookup tool is free to use. It reads the same publicly available openFDA data and refreshes weekly.
We pull from the openFDA API every week, so the device counts and timelines reflect the most recent reports the FDA has published.
No. MAUDE is passive surveillance, so report counts reflect reporting behavior rather than true event rates. Counts can be affected by sales volume, publicity, and recalls. Use the data to spot patterns worth investigating, not to rank devices by safety.
This tool covers 32 cardiac device types across eight categories, including pacemakers and ICDs, ablation catheters, TAVR and structural heart devices, coronary stents, and mechanical circulatory support devices such as Impella and LVADs.
