medical Class II Updated 2019-12-25

Arrow International Inc recalls Arrow Berman Angiographic Catheter 50cc Item Number: AI-07

Recalled Product

Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130


Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number: 16F19H0089
View official government recall

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