Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130 Recalled by Arrow International Inc Due to Potential leak in the balloon extension line. If...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Arrow International Inc directly.
Affected Products
Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130
Quantity: 71 units
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Arrow International Inc
Arrow International Inc has 431 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report