GORE CARDIOFORM ASD Occluder. cardiovascular implant.
FDA Recall Z-0136-2023 · Posted 2022-10-26
Recalling FirmW L Gore & Associates, Inc.
Recall StatusOpen, Classified
Product CodeMLV
Date Initiated2022-09-21
Product Quantity98 units
Reason for Recall
Due to manufacturing records (Release Test Results) indicating "Failed".
Firm 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
[email protected] 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
[email protected].
For questions, contact Gore Customer Service via email - [email protected]
Root Cause
Employee error
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.