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
Reported: September 1, 2021 Initiated: July 12, 2021 #Z-2340-2021
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.
Details
- Recalling Firm
- W. L. Gore & Associates Inc.
- Units Affected
- 3,364 units
- 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, UT, VA, WA, WI, WV, WY and the countries of AUS, CAN, CHE, DEU, DNK, ESP, FIN, FRA, GBR, GRC, HRV, HUN, IRL, ISR, ITA, JPN, MEX, NLD, NOR, POL, PRT, SMR, SWE.
- Location
- Phoenix, AZ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by W. L. Gore & Associates Inc.. Units affected: 3,364 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 1, 2021. Severity: Moderate. Recall number: Z-2340-2021.
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