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.
W. L. Gore is recalling certain balloon catheters that may leak during preparation, leading to insufficient or failed inflation. This could affect medical procedures requiring precise catheter function.
The catheter may leak from the guidewire lumen and y-hub during preparation. This leakage can cause the catheter to not inflate properly, potentially leading to failed medical procedures.
Healthcare professionals using these catheters for medical procedures are most at risk. Patients undergoing procedures with the recalled catheters could experience complications.
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.
Look for serial numbers between 22982051 and 23516741 on the catheter or its packaging.
The recalled catheter is a Gore Molding & Occlusion Balloon Catheter with REF Catalogue Number MOB37 and serial numbers between 22982051 and 23516741.
Complaints indicate the catheter may leak from the guidewire lumen and y-hub during preparation, causing insufficient or failed inflation.
The recall record does not specify a remedy, so contact the manufacturer for guidance.
We’ve drafted a message you can send W. L. Gore to request your refund or repair — edit it as you like.
Subject: Recall Z-2340-2021 — W. L. Gore W. L. Gore Hello, I own a W. L. Gore that is covered by recall Z-2340-2021 from W. L. Gore. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
