PCKUnclassifiedImplantLife-sustaining
Pediatric Ventricular Assist Device
Cardiovascular · 21 CFR 870.3545
A ventricular assist device (VAD) assists the left or right ventricle in maintaining circulatory blood flow. The device is either totally or partially implanted in the body.
MDR events6All time
Recalls0All time
Registered firms1Currently listed
510(k) clearances0All time
Recent MDR events
6 adverse event reports on file
- BERLIN HEARTMar 9, 2020MalfunctionBerlin Heart, Inc.9805365
- BERLIN HEARTApr 19, 2017InjuryBerlin HeartMW5069239
- BERLIN HEART EXCOR DEVICENov 29, 2016InjuryBerlin Heart GmbhMW5066380
- BERLIN HEART EXCOR VADApr 1, 2016MalfunctionBerlin HeartMW5061459
- BERLIN HEART EXCOR VADJul 18, 2014DeathBerlin Heart, Inc.3956940
- BERLIN HEART EXCOR DRIVING TUBEMar 5, 2013MalfunctionBerlin Heart Gmbh3004582654-2013-00004
Event type breakdown
Malfunction3
Injury2
Death1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
1 firms currently registered for this product code
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.