Recall Z-2340-2021— W. L. Gore & Associates Inc.

Name: FDA recall Z-2340-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-12

Class II · Ongoing

Class II FDA medical device recall by W. L. Gore & Associates Inc., initiated 2021-07-12. It names one FDA 510(k) clearance: K172567. 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. Reason: 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..

Recalling firm: W. L. Gore & Associates Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-07-12
Firm location: Phoenix, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K172567 — GORE Molding and Occlusion Balloon CatheterW. L. Gore and Associates, Inc.·cleared 2018-01-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.