Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter Recalled by Cook Inc. Due to Incorrect product labeling. Product labeled as 6mm x...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cook Inc. directly.
Affected Products
Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0; UDI: 10827002522647 and 10827002522524 Product Usage: The Advance¿ 35LP Low Profile PTA Balloon Dilation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
Quantity: 40 total products
Why Was This Recalled?
Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cook Inc.
Cook Inc. has 262 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report