FDA Medical Device Recalls (openFDA)
W L Gore & Associates, Inc.: GORE CARDIOFORM Septal Occluder, REF: GSX0030A
- Recall number
- Z-1048-2023
- Recalling firm
- W L Gore & Associates, Inc.
- Product
- GORE CARDIOFORM Septal Occluder, REF: GSX0030A
- Status
- Open, Classified
- Initiated
- 2022-12-14
- Posted
- 2023-02-01
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Employee error
- Action
- 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
- Quantity
- 14
- Distribution
- US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA.
- Lot, serial or model codes
- UDI-DI/Serial Numbers: 00733132631032/25556388, 25556389, 25556390, 25556391, 25556392, 25556393, 25556394, 25556398, 25556399, 25556400, 25556401, 25556402, 25556403, 25556406
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MLV
- Firm FEI
- 2017233
- Firm city
- Flagstaff
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28