W L Gore & Associates, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1048-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

GORE CARDIOFORM Septal Occluder, REF: GSX0030A

Product Classification:

Class II

Date Initiated: December 14, 2022

Date Posted: February 8, 2023

Recall Number: Z-1048-2023

Event ID: 91380

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.

Status: Ongoing

Product Quantity: 14

Code Information:

UDI-DI/Serial Numbers: 00733132631032/25556388, 25556389, 25556390, 25556391, 25556392, 25556393, 25556394, 25556398, 25556399, 25556400, 25556401, 25556402, 25556403, 25556406

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated