Oscor Inc.: Introducer, Catheter
Recall Summary Oscor Inc. is recalling certain introducer sheaths (medical tubes) used with Abiomed Impella heart pump systems because they may leak at connection points due to manufacturing defects. The recall affects 14Fr and 23Fr sized sheaths distributed in Massachusetts. This is classified as a Class II recall, indicating a potential health risk but not an immediate life-threatening situation.
- Recalling firm
- Oscor Inc.
- Product
- Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. 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/50c6f063-3abd-43cc-adf1-675fb8b6833d