Arrow Berman Angiographic Catheter Recalled for Potential Balloon Leak
Arrow International Inc is recalling specific Arrow Berman Angiographic Catheters due to a potential leak in the balloon extension line that could cause serious injury or death.
What this means for you
Illness, injury, or structural failure has been reported. 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 the Arrow Berman Angiographic Catheter 60cm (Item Number: AI-07130-J). The recall involves units with Lot Number 16F19H0093. These products were distributed nationwide in the United States and in Canada.
The recall is being issued because of a potential leak in the balloon extension line. If a leak is present and goes undetected during pre-use testing, it could cause the balloon to 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 facilities and consumers should check their inventory for the specific item number and lot number listed above. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Arrow Berman Angiographic Catheter 60cm Item Number: AI-07130-J
- Manufacturer
- Arrow International Inc
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 1
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: 16F19H0093
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.
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