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Arrow International Inc recalls Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130
Recalled December 25, 2019 · FDA recall Z-0715-2020 · Arrow International
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 · FDA Class II
Units
71 units
Sold at
U.S. Nationwide, Canada
Description
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
Product
Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130
Manufacturer(s)
Arrow International Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →