Use caution Medical device recall · FDA · Published May 24, 2019

Cook Advance Enforcer 35 Balloon Catheter Recall: Balloons May Burst During Use

Cook Inc. recalls Advance Enforcer 35 Focal Force PTA Balloon Catheter due to balloons bursting below rated pressure, risking vessel injury or procedure delays. Affected units have specific lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1758-2019Medical device Cook Inc. ›

Use caution until it’s fixed

Multiple complaints were received for balloons bursting below the rated burst pressure. Potential adverse events that may occur if an affected product is used include a delay in the procedure, additional intervention, vessel injury, and balloon fragmentation in the patient.

Take action

Contact the company

Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120

✎ GovInfoNow plain-language explainer

Cook Inc. is recalling its Advance Enforcer 35 Focal Force PTA Balloon Catheter because balloons can burst below the rated pressure during use. This may cause delays in medical procedures, additional interventions, or vessel injuries to patients. Read more at govinfonow.com/recall/67875-cook-advance-enforcer-35-balloon-catheter-recall-balloons-may-burst.

Source Summary by GovInfoNow · govinfonow.com/recall/67875-cook-advance-enforcer-35-balloon-catheter-recall-balloons-may-burst · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1758-2019

Cite this page

“Cook Advance Enforcer 35 Balloon Catheter Recall: Balloons May Burst During Use.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67875-cook-advance-enforcer-35-balloon-catheter-recall-balloons-may-burst. Based on FDA recall #Z-1758-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1758-2019%22&limit=1).

The FDA announced on May 24, 2019, that Cook Inc. is recalling the Advance Enforcer 35 Focal Force PTA Balloon Catheter due to balloons bursting below rated pressure. This Class I recall affects 73 units distributed worldwide.

How to tell if you have it

Brand: Cook Inc.
Product: Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm
Catalog Number: ASB5-35-135-6-4
REF Number: G35257
Lot Numbers: 9338194, 9234423, 9278982, 9209468, 9248603, 9320429

The hazard

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 (Nov. 12, 2021), Cook Skinny Needle with Chiba Tip Recall (Oct. 13, 2021), and Cook Transseptal Needle with Catheter Recall (Oct. 8, 2021). Other recent recalls of similar products include LeMaitre TufTex Catheter Recall (Aug. 28, 2026), Cook Aurous Sizing Catheters Recall (April 2, 2026), and Microvention Bobby Balloon Guide Catheter Recall (April 30, 2026).

How to tell if you have this one

Check the product's catalog number ASB5-35-135-6-4 and lot numbers: 9338194, 9234423, 9278982, 9209468, 9248603, 9320429. The catheter is used for peripheral artery procedures, not for cerebral or coronary vessels.

Brand
Cook Inc.
Category
Medical device

FDA recall event · 3 products

All 3 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.

Classification
Class I
Status
Terminated
Distribution
Worldwide Distribution - US Nationwide The affected product was distributed to the following states: FL, OH, WA. The products were distributed to the following foreign countries: Belgium, Denmark, Finland, Germany, Italy, Netherlands, Norway, Poland, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

Recall number	Product, codes & lots	Quantity
Z-1756-2019	Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/50cm, Catalog Number ASB5-35-50-6-4, REF Number G35248 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended 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. Not for use in the cerebral or coronary vasculature.; Lot Numbers: 9234424, 9331618	34
Z-1757-2019	Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/80cm, Catalog Number ASB5-35-80-6-4, REF Number G35252 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended 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. Not for use in the cerebral or coronary vasculature.; Lot Numbers: 9212015, 9243035, 9320430, 9386804	131
Z-1758-2019	Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35257 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended 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. Not for use in the cerebral or coronary vasculature.; Lot Numbers: 9338194, 9234423, 9278982, 9209468, 9248603, 9320429	73

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the product's catalog number and lot numbers to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 3 states.

FDA distribution: “Worldwide Distribution - US Nationwide The affected product was distributed to the following states: FL, OH, WA. The products were distributed to the following foreign countries: Belgium, Denmark, Finland, Germany, Italy, Netherlands,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Ohio, Washington.

Recall timeline

FDA terminated this recall 5 months after the firm started it.

May 24, 2019Firm started the recall
Jun 17, 2019FDA classified it Class I
Jun 26, 2019Published in FDA’s Enforcement Report
Oct 31, 2019FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/67875-cook-advance-enforcer-35-balloon-catheter-recall-balloons-may-burst">Cook Advance Enforcer 35 Balloon Catheter Recall: Balloons May Burst During Use (GovInfoNow)</a>

Where this comes from

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-1758-2019 (May 24, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1758-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 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.