Oscor Inc.: Introducer, Catheter
Recall Summary Oscor Inc. is recalling certain Impella heart pump introducer kits (14Fr and 23Fr sizes) distributed in Massachusetts due to manufacturing defects that could cause leaking from multiple points on the device. The leaking could occur from the sidearm, under the sheath cap, or along the hub area. This is a Class II recall affecting devices distributed in Massachusetts.
- Recalling firm
- Oscor Inc.
- Product
- Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 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/9945aab9-8644-4509-8c56-e535eeb520c9