W L Gore & Associates, Inc. 2023-02-08 Health serious FDA
Health · FDA · Recall #FDA-Z-1048-2023
GORE CARDIOFORM Septal Occluder, REF: GSX0030A Recall
Issued February 8, 2023 · W L Gore & Associates, Inc.
In February 2023, W L Gore & Associates, Inc. recalled the GORE CARDIOFORM Septal Occluder, REF: GSX0030A, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using GORE CARDIOFORM Septal Occluder, REF: GSX0030A right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact W L Gore & Associates, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- W L Gore & Associates, Inc.
- Category
- Health
- Recall date
- February 8, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA.
- Recall number
- FDA-Z-1048-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- W L Gore & Associates, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.