Catheter Introducer Correction

1 recall on record · Last recall: Aug 10, 2026

Safety Score

97/100

Excellent

Based on recall frequency and severity over the past 3 years, with older recalls weighted less.

Severity Breakdown

Class I — Serious

Class II — Moderate

Class III — Low Risk

Unclassified

Recall Timeline

FDAAug 10, 2026

Catheter Introducer Correction: Abiomed and Oscor Issue Correction for Catheter Introducer

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.

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