Arrow recalls 60cm 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 60cm 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 slow deflation after placement. If undetected by clinicians during use, this could lead to contrast injection into blood vessels, potentially causing serious injury or death.
Healthcare professionals who use Arrow Berman Angi: 60cm angiographic catheters with item number AI-07130-J. Patients receiving procedures using these catheters are at risk if the leak goes undetected.
Check for the item number AI-07130-J on the catheter packaging or label. The product was sold with lot number 16F19H0093.
Immediately stop using the catheter if it has the item number AI-07130-J and lot number 16F19H0093.
The item number is AI-07130-J with lot number 16F19H0093.
Yes, if undetected during use, it could cause contrast injection into blood vessels, leading to serious injury or death.
Look for the item number AI-07130-J and lot number 16F19H0093 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-0716-2020 — Arrow Arrow Hello, I own a Arrow that is covered by recall Z-0716-2020 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.
