Arrow Berman Angiographic Catheter Recalled for Potential Leak
Arrow International Inc. is recalling 71 units of Arrow Berman Angiographic Catheters due to a potential leak in the balloon extension line that could cause serious injury or death.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the defect could result in serious injury or death, which aligns with the rubric criteria for a Severe (4) rating involving significant injury reports or potential for serious harm.
Plain-English summary
Arrow International Inc. is recalling 71 units of Arrow Berman Angiographic Catheter 50cc (Item Number: AI-07130, Lot Number: 16F19H0089). The recall is due to a potential leak in the balloon extension line. The affected products were distributed nationwide in the U.S. and in Canada.
If a leak is present and goes undetected during pre-use testing, the balloon may deflate slowly after placement. If the leak is not detected by clinicians during use, it could result in contrast injection into vascular or cardiac tissue, which could lead to serious injury or death.
Healthcare providers and facilities that have received these products should stop using them and contact Arrow International Inc. for instructions on return or disposal.
The recalled product
- Product
- Arrow Berman Angiographic Catheter 50cc Item Number: AI-07130
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 71
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 16F19H0089
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Arrow International Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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