Z-2340-2021Class II

Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr...

Name: Z-2340-2021 Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr...
Creator: W. L. Gore & Associates Inc.
Published: 2021-07-12
License: https://open.fda.gov/license/

W. L. Gore & Associates, Inc. / initiated 2021-07-12 / Open, Classified

FDA source

W. L. Gore & Associates Inc. began a recall of Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797... on 2021-07-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2340-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-07-12
Posted: 2021-08-25
Recalling firm: W. L. Gore & Associates, Inc.
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
Product code: MJN Catheter, Intravascular Occluding, Temporary
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.
FDA root cause: Process change control
Action: 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 [email protected] 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 [email protected] within 2 weeks of receipt of this letter. No further action is needed.
Quantity in commerce: 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.
Product codes and lots: Serial Numbers between 22982051 - 23516741

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2340-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2340-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-01	2021-08-25

Product code MJN

K172567Class IIGORE Molding and Occlusion Balloon CatheterW. L. Gore and Associates, Inc. / cleared 2018-01-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)