CLASS II ONGOING Device recall · Reported 1 Sep 2021 · FDA Enforcement Report
Gore Molding & Occlusion Balloon Catheter recalled
W. L. Gore & Associates is recalling Gore Molding & Occlusion Balloon Catheter, distributed nationwide in the US. The recall was initiated on 12 Jul 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2340-2021
- FDA event ID
- 88331
- Recalling firm
- W. L. Gore & Associates, Phoenix, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Jul 2021
- FDA classified
- 25 Aug 2021
- Reported
- 1 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 12 Jul 2021 | Recall initiated by company | |
| 25 Aug 2021 | Classified by FDA | +44 days |
| 1 Sep 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesota
Questions about this recall
Why was it 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 lots are affected?
Serial Numbers between 22982051 - 23516741
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from W. L. Gore & Associates
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | The Gore Viabil Short Wire Biliary Endoprosthesis recalled | W L Gore & Associates | Labeling Errors | Nationwide |
| Device | CLASS II | Gore Viabil Short Wire Biliary Endoprosthesis recalled | W L Gore & Associates | Labeling Errors | Nationwide |
| Device | CLASS II | Gore Viabil Short Wire Biliary Endoprosthesis recalled | W L Gore & Associates | Labeling Errors | Nationwide |
| Device | CLASS II | GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component recalled | W L Gore & Associates | Other | Nationwide |
| Device | CLASS II | Gore Acuseal Vascular Graft recalled by W L Gore & Associates | W L Gore & Associates | Packaging Defects | 51 states |
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