Z-0715-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2019
- Initiation Date
- November 15, 2019
- Termination Date
- June 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 71 units
Product Description
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 Pattern
U.S. Nationwide, Canada
Code Information
Lot Number: 16F19H0089