Cook recalls Advance 35LP Low-Profile PTA Balloon Dilatation Catheters with incorrect balloon size labels. Product labeled as 6mm x 2cm may have a 4mm x 4cm balloon, causing potential misuse during medical procedures.
“Cook Advance 35LP Catheter Recall: Incorrect Balloon Size Labeling.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/71381-cook-advance-35lp-catheter-recall-incorrect-balloon-size-labeling. Based on FDA recall #Z-1521-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1521-2018%22&limit=1).
The FDA announced on April 16, 2018, that Cook Inc. is recalling Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheters due to incorrect product labeling. The hazard involves mismatched balloon sizes and labels for catalog numbers PTA5-35-135-6-2 .0 and PTA5-35-135-4-4 .0.
According to the FDA, products labeled as 6mm x 2cm balloons are packaged with a 4mm x 4 cm balloon label, and vice-versa. The recall affects 40 total products distributed worldwide, including in Arizona, Delaware, Florida, Georgia, Idaho, Illinois, Kentucky, Michigan, Missouri, New Hampshire, New Jersey, Pennsylvania, Rhode Island, Texas, Utah, Peru, and nationwide.
Context
GovInfoNow's records show Cook Inc. has 38 other recalls on record since July 31, 2017. Other recent recalls of similar products include Cook Flexor Check-Flo Introducer Ansel Modification Recall (Nov. 12, 2021), Cook Skinny Needle with Chiba Tip Recall (Oct. 13, 2021), and Cook Transseptal Needle Recall (Oct. 8, 2021). Other recent recalls of similar products include Cook Centimeter Sizing Catheters Recall (April 2, 2026), Cook Aurous Sizing Catheters Recall (April 2, 2026), and Olympus EZDilate Balloon Dilator Recall (Aug. 19, 2026).
How to tell if you have this one
Check for catalog numbers PTA5-35-135-6-2 .0 or PTA5-35-135-4-4 .0. The product was sold with UDI numbers 10827002522647 and 10827002522524.
Brand
Cook
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Label
Verify the balloon size label on the catheter to ensure it matches the catalog number.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 15 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide Distribution - US Nationwide in the states of AZ, DE, FL, GA, ID, IL, KY, MI, MO, NH, NJ, PA, RI, TX, UT and the country of Peru” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Delaware, Florida, Georgia, Idaho, Illinois, Kentucky, Michigan, Missouri, New Hampshire, New Jersey, Pennsylvania, Rhode Island, Texas, Utah.
Recall timeline
FDA terminated this recall 14 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1521-2018 (April 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1521-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.