Class 2 Device Recall GORE CARDIOFORM SEPTAL OCCLUDER

• Date Initiated by Firm: September 02, 2021
• Create Date: October 22, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0169-2022
• Recall Event ID: 88683
• PMA Number: P050006S044
• Product Classification: Transcatheter septal occluder - Product Code MLV
• Product: REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661 *Not distributed within the US
• Code Information: serial numbers 22689696 through 23569078
• Recalling Firm/ Manufacturer: W L Gore & Associates, Inc.; 3750 W Kiltie Ln; Flagstaff AZ 86005-8712
• For Additional Information Contact: Gore Customer Service; 800-528-8763
• Manufacturer Reason for Recall: Septal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs.
• FDA Determined Cause: Software change control
• Action: Gore initiated distribution of "Urgent Medical Device Recall" Notification to affected consignees between the dates of September 2, 2021 - September 21, 2021. The customer communication was distributed via Email and UPS. In addition, to informing consignees about the recall, Gore asked consignees to take the following actions: 1. Identify and return any unused devices within the scope of this voluntary recall. Return Authorization number can be found on the CUSTOMER RESPONSE FORM. 2. Please complete and sign the enclosed CUSTOMER RESPONSE FORM and return to WLGore3120@sedgwick.com within 3 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 WLGore3120@sedgwick.com within 3 weeks of receipt of this letter. No further action is needed. 5. Please contact your local Gore field sales associate with any questions regarding this notice, and to coordinate the return and replacement of any unused affected devices. Additionally, you may also contact Gore Customer Service (Email: MPDCustomerCare@wlgore.com; or by phone (U.S. toll free: (800) 528-8763)). 6. In the event that an adverse event occurs: Any adverse event involving the GORE¿ CARDIOFORM Septal Occluder should be reported to the manufacturer and the country specific regulatory authorities immediately. To report an event to W. L. Gore & Associates, email: medcomplaints@wlgore.com or contact: USA: 800 528 1866 Ext. 44922 / 928 864 4922, Fax 928 864 4364 Healthcare professionals and consumers may report adverse events or quality problems directly to FDA using the FDA MedWatch Website: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Quantity in Commerce: 846 units
• Distribution: US: AL,AR, AZ, CA, CO, CT, DC, 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,SC,SD,TN,TX,UT,VA,VT,WA,WI, WV OUS: AUS, AUT, CAN, CHE, DEU, DNK, ESP, FRA, GBR, GRC, IRL, ITA, MEX, NLD, NOR, PRT, SAU, SWE
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = MLV and Original Applicant = W.L. GORE & ASSOCIATES,INC