Regulation
Abiomed’s Impella heart pump introducer kits linked to leakage issue in FDA alert
Abiomed reported eight cases of major bleeding associated with leakage in Impella heart pump introducer kits, including three deaths, triggering an FDA safety alert. The company disclosed the issue through regulatory channels as part of ongoing device surveillance.
The source
This brief is a MedIndexer summary of reporting by Medical Device Network. To read the full story, head to the source.
Read the full story at Medical Device Network