The Recall Desk
HighFDA (Devices)·Z-2340-2021·Announced 2021-09-01

Gore Balloon Catheter Leakage Recall Affects 3,364 Units Worldwide

W.L. Gore is recalling 3,364 units of its Molding & Occlusion Balloon Catheter due to leakage from the guidewire lumen and y-hub that can prevent proper inflation. No injuries have been reported.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a medical device where the defect can result in loss of intended function. No injuries or deaths have been reported, limiting the score to a maximum of 3 per the rubric criterion for risk-of-harm products without reported injury.

Plain-English summary

W.L. Gore & Associates Inc. is recalling 3,364 units of the Gore Molding & Occlusion Balloon Catheter (REF MOB37) due to a leakage defect affecting the guidewire lumen and y-hub connection. The leakage can occur during catheter preparation and may result in insufficient inflation or complete inability to inflate the balloon, compromising the device's intended function.

The recalled units were distributed worldwide and throughout the United States. The affected serial numbers range from 22982051 to 23516741. Healthcare facilities and providers who have received this product should immediately discontinue use of affected units.

No injuries or illnesses have been reported to date. Healthcare providers should contact their hospital supply personnel or W.L. Gore directly regarding return or replacement of affected units. The FDA is monitoring this recall.

The recalled product

Product
Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489
Manufacturer
W. L. Gore & Associates Inc.
Category
Medical Device — Vascular Catheter
Hazard
  • catheter-leakage
  • inflation-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Numbers between 22982051 - 23516741

Distribution

Distributed nationwide across the United States.

Related recalls

Same category