GORE CARDIOFORM ASD Occluder. cardiovascular implant.

FDA device recall Z-0136-2023 · posted 2022-10-26 · Open, Classified

Recall details

Recalling firm

W L Gore & Associates, Inc.

Reason for recall

Due to manufacturing records (Release Test Results) indicating "Failed".

Action taken

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

Root cause

Employee error

Status

Open, Classified

Product code

MLV

Quantity affected

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.

Date initiated

2022-09-21

Date posted

2022-10-26

Location

Flagstaff, AZ