GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Reported: February 8, 2023 Initiated: December 14, 2022 #Z-1048-2023
Product Description
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
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.
Details
- Recalling Firm
- W L Gore & Associates, Inc.
- Units Affected
- 14
- Distribution
- US Nationwide distribution in the states of NY, CA, FL, CT, TX, AR, IN, MA, MO, SD, VA.
- Location
- Flagstaff, AZ
Frequently Asked Questions
What product was recalled? ▼
GORE CARDIOFORM Septal Occluder, REF: GSX0030A. Recalled by W L Gore & Associates, Inc.. Units affected: 14.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 8, 2023. Severity: Moderate. Recall number: Z-1048-2023.
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