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

Recall date

November 15, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0715-2020

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

U.S. Nationwide, Canada

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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