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FDANovember 15, 2019device

Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by attending clinicians during use, it could result in contrast injection into the vascular or cardiac tissue which could result in serious injury or death

What to do

FDA enforcement status: Terminated

Brands named

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Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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