Arrow recalls 50cc angiographic catheters with potential balloon extension line leaks that could cause slow deflation or contrast injection into vascular tissue, risking serious injury or death.
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
Arrow is recalling 50cc angiographic catheters that may have a leak in the balloon extension line. If undetected during use, this leak could cause the balloon to deflate slowly or lead to contrast injection into blood vessels, potentially causing serious injury or death.
The catheter's balloon extension line may leak, causing the balloon to deflate slowly after placement. If the leak goes undetected by clinicians during use, contrast dye could enter blood vessels or cardiac tissue, potentially causing serious injury or death.
Healthcare professionals who use Arrow Berman Angi: 50cc angiographic catheters with item number AI-07130. Those most at risk are clinicians who may have used the catheter without detecting a leak during pre-use testing.
Check for the item number AI-07130 on the catheter packaging or label. This specific model was sold with lot number 16F19H0089.
Immediately stop using the catheter if it has the item number AI-07130.
No, the catheter may have a leak that could cause serious injury or death if undetected during use.
Stop using it immediately and contact Arrow for further instructions.
Look for the item number AI-07130 on the catheter packaging or label.
We’ve drafted a message you can send Arrow to request your refund or repair — edit it as you like.
Subject: Recall Z-0715-2020 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-0715-2020 from Arrow. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
