Class 2 Device Recall GORE CARDIOFORM ASD Occluder

• Date Initiated by Firm: September 21, 2022
• Date Posted: October 26, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0136-2023
• Recall Event ID: 90912
• Product Classification: Transcatheter septal occluder - Product Code MLV
• Product: GORE CARDIOFORM ASD Occluder. cardiovascular implant.
• Code Information: Model Numbers: ASD37A UDI-DI Codes: 00733132636501 Serial Numbers: 24468090 24468092 24468093 24468096 24468097 24468098 24468099 24468103 24468104 24480314 24480315 24480316 24480318 24468102 24468094 24468100 24468101 24480317 24468091 24468095 Model Number: ASD44A UDI-DI Code: 00733132636518 Serial Numbers: 24281498 24281499 24281500 24281501 24281502 24281507 24281509 24281511 24281512 24429270 24429271 24429276 24429278 24429279 24480351 24480352 24480353 24545359 24550148 24550149 24578446 24578447 24281506 24429272 24429273 24429274 24429277 24545360 24545362 24550147 24550150 24550151 24578443 24578445 24281503 24281504 24281505 24281508 24281510 24429275 24480354 24480355 24545358 Model Number: ASD44E UDI-DI Code: 00733132636617 Serial Numbers: 24305083 24305081 24550693 24550694 24305079 24305080 24305082 24550695 24550696 24550697
• Recalling Firm/ Manufacturer: W L Gore & Associates, Inc.; 3750 W Kiltie Ln; Flagstaff AZ 86005-8712
• For Additional Information Contact: MPD Customer Care; 800-528-8763
• Manufacturer Reason for Recall: Due to manufacturing records (Release Test Results) indicating "Failed".
• FDA Determined Cause: Employee error
• Action: Between 09/21-32/2022, the firm sent an "URGENT MEDICAL DEVICE RECALL/FIELD SAFETY NOTICE" via FedEx 2nd Day (U.S.), Postal Mail (EMEA), and Personal Delivery (Japan), informing customers that W.L. Gore & Associates (Gore) identified devices that were incorrectly released following a documented failure of a subset of quality tests. A failure of the subset of quality tests could potentially result in increased risks during the release of the device from the delivery system for the affected devices. Customer are instructed to: ¿ Identify and return any unused devices within the scope of this recall. ¿ Complete and sign the enclosed CUSTOMER RESPONSE FORM and return to FieldActionTeam@wlgore.com within 2 weeks of receipt of this notification. ¿ Share this letter with others in their institution as appropriate. Transfer this notice to other organization(s) as appropriate. ¿ If a listed device has been used, there is no patient follow-up needed and no further actions required other than informing Gore the device was used. Indicate the used device(s) on the CUSTOMER RESPONSE FORM and return to FieldActionTeam@wlgore.com. For questions, contact Gore Customer Service via email - MPDCustomerCare@wlgore.com
• Quantity in Commerce: 98 units
• Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AZ, CA, CO, DC, FL, GA, IA, ID, IL, ME, MN, NC, NY, JPA, TN, TX, WA, and WI. The countries of Denmark, and Japan.
• 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.