FDA recall Z-0715-2020

Product

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

Reason for recall

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

Distribution

U.S. Nationwide, Canada

Key facts

Status

Terminated

Initiation date

2019-11-15

Report date

2019-12-25

Termination date

2020-06-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Reading, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0715-2020