GORE CARDIOFORM Septal Occluder, REF: GSX0030A

FDA device recall Z-1048-2023 · posted 2023-02-01 · Open, Classified

Recall details

Recalling firm

W L Gore & Associates, Inc.

Reason for recall

Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could potentially result could result in occluder embolization, anoxic brain injury, central venous or arterial perforation or rupture.

Action taken

On 12/14/22, recall notices were mailed to customers informing them to take the following actions: 1) Identify and return any unused devices. 2) Complete and return the customer response form to to FieldActionTeam@wlgore.com 3) This notice needs to be shared with those who should be aware within your institution or to any organization where potentially affected devices have been transferred. Customers with questions can contact the firm at MPDCustomerCare@wlgore.com

Root cause

Employee error

Status

Open, Classified

Product code

MLV

Quantity affected

14

Distribution

US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA.

Date initiated

2022-12-14

Date posted

2023-02-01

Location

Flagstaff, AZ