W L Gore recalls GORE CARDIOFORM Septal Occluder models with incomplete quality test documentation that could lead to embolization or serious injury during cardiac procedures.
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.
W L Gore is recalling a specific model of septal occluder device due to incomplete quality testing that might cause the device to become dislodged during surgery, potentially leading to serious complications like embolization or organ damage.
The septal occluder device may not properly stay in place during the procedure because of incomplete quality testing. This could cause the device to become dislodged, leading to embolization (where part of the device travels through the bloodstream), anoxic brain injury, or damage to blood vessels.
Patients who have been prescribed this specific septal occluder device for cardiac procedures are affected. Medical professionals using the device during procedures are at higher risk due to the potential for serious complications.
Check for the reference number GSX0030A on the device. The UDI-DI/Serial Numbers listed include 00733132631032/25556388 through 25556403 and 25556406.
Review the device's reference number and serial numbers to confirm if it is part of the recalled model.
The septal occluder was released with incomplete quality test documentation that could result in the device becoming dislodged during surgery, potentially causing embolization or serious injury.
Check the device's reference number and serial numbers to see if it is part of the recalled model. Contact W L Gore for further instructions.
Yes, the incomplete quality testing could lead to the device becoming dislodged during surgery, which might cause embolization, brain injury, or blood vessel damage.
We’ve drafted a message you can send W L Gore to request your refund or repair — edit it as you like.
Subject: Recall Z-1048-2023 — W L Gore W L Gore Hello, I own a W L Gore that is covered by recall Z-1048-2023 from W L Gore. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
