Oscor Inc.: Introducer, Catheter
Recall Summary Oscor Inc. is recalling certain Abiomed introducer kits used with Impella heart pumps because the sheaths may leak from multiple points, including the sidearm, under the sheath cap, and at hub connection areas. The recalled products are 14Fr and 23Fr hemostatic peel away introducer systems with infusion sideports that were distributed in Massachusetts. This is a Class II recall, meaning the product could cause serious health problems or failure, but is not expected to cause death.
- Recalling firm
- Oscor Inc.
- Product
- Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-10
- Status
- Open, Classified
- Areas affected
- MA
- Distribution
- Distribution in the US state of MA
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/f9edc7c2-c2f2-4cad-ad94-83a983a5249b