Recall
Active
FDA
Official source
Oscor Inc.: Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with...
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region....
- Company
- Oscor Inc.
- Deadline
- No deadline listed
- Source
- U.S. Food and Drug Administration