Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0715-2020 — Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130

U.S. FDA — Device Enforcement · United States · 2019-11-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0715-2020
Date of alert
2019-11-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Arrow International Inc
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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