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
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Contact the company
📍Recalling firmArrow International Inc2400 Bernville Rd · Reading, PA 19605-9607
“Arrow Berman Angiographic Catheter 60cm Recall: Potential Balloon Leak Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66515-arrow-berman-angiographic-catheter-60cm-recall-potential-balloon-leak-risk. Based on FDA recall #Z-0716-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0716-2020%22&limit=1).
The FDA announced on November 15, 2019, that Arrow International Inc. recalled the Arrow Berman Angiographic Catheter 60cm (Item Number: AI-07130-J) due to a potential balloon leak hazard. The agency classified the recall as Class II.
How to tell if you have it
Brand: Arrow
Product: Arrow Berman Angiographic Catheter 60cm
Item Number: AI-07130-J
Lot Number: 16F19H0093
The hazard
According to the FDA, a potential leak in the balloon extension line could cause the balloon to deflate slowly after placement. If undetected during use, this could result in contrast injection into vascular or cardiac tissue, potentially causing serious injury or death.
Context
GovInfoNow's records show Arrow International Inc. has issued 52 other recalls since June 1, 2017. Recent brand recalls include the Arrow Arterial Kits and Trays recall on July 26, 2024, for packaging open seals risk, and the Arrow UltraFlex Intra-Aortic Balloon Catheter Kit recall on April 29, 2024, for serious health consequences. Other recent recalls of similar products include the Arrow Pressure Injectable Catheters Recall (March 11, 2026) and the Microvention Bobby Balloon Guide Catheter Recall (April 30, 2026).
How to tell if you have this one
Check for the item number AI-07130-J on the catheter packaging or label. The product was sold with lot number 16F19H0093.
Brand
Arrow
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
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.
Official source: FDA Recall #Z-0716-2020 (November 15, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0716-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.