FDADecember 14, 2022device
GORE CARDIOFORM Septal Occluder, REF: GSX0030A
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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 to do
FDA enforcement status: Ongoing
Brands named
w l gore associates
UPCs
00733132631032
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- CPSCMissry Associates Recalls Misco Sports Light-Up Racket Sets Due to Risk of Serious Injury or Death from Battery Ingestion; Violate Mandatory Standard for Toys2026-05-28
- CPSCMissry Associates Recalls Misco Sports Badminton Toy Sets Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Toys2026-05-14
- CPSCClark Associates Recalls Lancaster Table & Seating Powder-Coated Aluminum Outdoor Restaurant Chairs and Barstools Due to Fall Hazard2026-02-05
- FDAGORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.2025-08-26
- FDAGuaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16 fl oz (473 ml) bottles, PAI Pharmaceutical Associates, Inc., Greenville, SC 29605, NDC 0121-0775-162025-01-07
- CPSCClark Associates Recalls Lancaster Table & Seating Plastic Restaurant High Chairs Due to Fall Hazard2024-07-25
- FDAGORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;2024-07-03
- FDAHeparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference numbers: United States: BXB055902C, BXB063902C, BXB065902C, BXB067902C, BXB073902C, BXB075902C, BXB077902C, BXB083902C, BXB085902C, BXB087902C, BXB093902C, BXB095902C, BXB097902C *For Clinical use.2024-07-01
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