Use cautionMedical device recall · FDA · Published July 12, 2021
W. L. Gore Recalls Balloon Catheter Due to Leakage Risk
W. L. Gore recalls specific balloon catheters for potential leakage during use, which could cause insufficient inflation or inability to inflate. Affected units have serial numbers between 22982051 and 23516741.
Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to inflate.
Take action
Contact the company
📍Recalling firmW. L. Gore & Associates Inc.32360 N North Valley Pkwy · Phoenix, AZ 85085-4228
“W. L. Gore Recalls Balloon Catheter Due to Leakage Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62214-w-l-gore-recalls-balloon-catheter-due-to-leakage-risk. Based on FDA recall #Z-2340-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2340-2021%22&limit=1).
The Food and Drug Administration announced on July 12, 2021, that W. L. Gore & Associates Inc. is recalling the Gore Molding & Occlusion Balloon Catheter due to leakage risks. The agency issued recall number Z-2340-2021 for the Class II device.
How to tell if you have it
Brand: W. L. Gore
Product: Gore Molding & Occlusion Balloon Catheter
REF Catalogue Number: MOB37
Serial Numbers: between 22982051 - 23516741
Size: 10 mm - 37 m 10 Fr
Guidewire Compatibility: 0.035"
Quantity: 3,364 units
The hazard
The recall addresses complaints concerning balloon catheter leakage from the guidewire lumen and the y-hub during preparation. This defect may result in either insufficient inflation or an inability to inflate the device.
Context
GovInfoNow's records show W L Gore & Associates, Inc. has 18 other recalls on record since September 25, 2017. Other recent recalls of similar products include the Microvention Bobby Balloon Guide Catheter Recall (April 30, 2026), the LeMaitre TufTex Catheter Recall (August 28, 2026), and the Medline Convenience Kits with Swan-Ganz Catheters Recalled Due to Leak Risk (May 28, 2026).
How to tell if you have this one
Check for serial numbers between 22982051 and 23516741 on the catheter packaging or label. The product is a 10 mm - 37 m 10 Fr Guidewire-compatible balloon catheter.
Brand
W. L. Gore
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Number
Look for serial numbers between 22982051 and 23516741 on the catheter or its packaging.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 46 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA published this recall 51 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
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-2340-2021 (July 12, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2340-2021 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.