FDA MedWatch Safety AlertsOriginal article
Catheter Introducer Correction: Abiomed and Oscor Issue Correction for Catheter Introducer
Regulatory14Fr Introducer23Fr IntroducerNegative
AI Analysis
Summary
Abiomed and Oscor have issued a correction for 14Fr and 23Fr catheter introducers due to a potential sheath leakage issue that may increase the risk of access-site bleeding.
Outcome Details
Potential for introducer sheath leakage identified, may increase risk of access-site bleeding
Importance:4/10
Sentiment:
-0.70
medical devicesafety issuecathetercorrection noticebleeding risk
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Published by FDA MedWatch Safety Alerts on August 10, 2026 4:00 AM