W. L. Gore & Associates Inc. 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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

On July 23, 2021 issue a "Urgent Medical Device Recall" notification to affected consignees via UPS. In addition to informing consignees about the recall the customer notification ask consignees to take the following actions: 1. Identify and return any unused devices within the scope of this voluntary recall. 2. Please complete and sign the enclosed CUSTOMER RESPONSE FORM and return to WLGore4731@stericycle.com within 2 weeks of receipt of this notification. 3. Please share this letter with others in your hospital or clinic as appropriate. 4. If a listed device has been used, there is no patient-follow up needed and there are no further actions needed other than informing Gore the device was used. Please indicate the used devices on the CUSTOMER RESPONSE FORM and return to WLGore4731@stericycle.com within 2 weeks of receipt of this letter. No further action is needed.