Early Alert: Catheter Introducer Issue From Abiomed And Oscor

Abiomed and Oscor have identified that their 14Fr and 23Fr Catheter Introducers may leak, which could lead to bleeding at the insertion site. This early alert affects the company's catheter introducer products. The companies are notifying customers about this potential issue.

Recalling firm

Abiomed and Oscor

Product

Catheter Introducer

Reason

Abiomed and Oscor have identified a potential for introducer sheath leakage in 14Fr and 23Fr Introducers that may increase the risk of access-site bleeding.

Category

medical device recall

Country

United States

Agency

FDA-MEDWATCH-RSS

Recall date

2026-06-18

Status

Ongoing

Official recall notice from FDA-MEDWATCH-RSS

Recall details on Nibble Recalls: https://trynibble.app/recalls/46f26ba3-49a2-495d-8baa-82349d538427