Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
Reported: December 25, 2019 Initiated: November 15, 2019 #Z-0716-2020
Product Description
Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
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
Details
- Recalling Firm
- Arrow International Inc
- Units Affected
- 1 unit
- Distribution
- U.S. Nationwide, Canada
- Location
- Reading, PA
Frequently Asked Questions
What product was recalled? ▼
Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J. Recalled by Arrow International Inc. Units affected: 1 unit.
Why was this product 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 25, 2019. Severity: Moderate. Recall number: Z-0716-2020.
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