Catheter Introducer Kit Recall: Abiomed Removes 14fr Low Profile Introducer Kits

Abiomed Catheter Introducer Kit Recall Abiomed is recalling certain 14Fr Low Profile Introducer Kits used in catheter procedures because prolonged use may cause blood clots to form. This recall affects medical facilities that have received these kits. The recall applies specifically to the 14Fr Low Profile model of this introducer device.

Reason

Prolonged use of the Abiomed 14Fr Low Profile Introducer may lead to thrombus formation.

Category

medical device recall

Country

United States

Agency

FDA-MEDWATCH-RSS

Recall date

2026-07-31

Status

Ongoing

Official recall notice from FDA-MEDWATCH-RSS

Recall details on Nibble Recalls: https://trynibble.app/recalls/a63435a0-fbcc-4261-8857-e7619e2cf799