W.L. Gore & Associates,inc
FDA adverse event reports naming W.L. Gore & Associates,inc as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: W.L. GORE & ASSOCIATES,INC.
- Total reports
- 1,115
- Deaths
- 112
- Injuries
- 943
- Malfunctions
- 48
Reports per year
Source: FDA adverse event reports by year received, 1999–2016. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- System, Endovascular Graft, Aortic Aneurysm TreatmentMIH822
- Prosthesis, Vascular Graft, Of 6mm And Greater DiameterDSY72
- Introducer, CatheterDYB48
- Stent, Superficial Femoral ArteryNIP46
- Mesh, Surgical, PolymericFTL44
- Transcatheter Septal OccluderMLV23
- Prosthesis, Tracheal, ExpandableJCT19
- Suture, Nonabsorbable, Synthetic, PolypropyleneGAW10
- Shunt, Portosystemic, EndoprosthesisMIR7
- Catheter, PercutaneousDQY3
Recent recalls
- 2024-08-06Open, ClassifiedProcess control
GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
Devices were labeled with an expiration date of four years and ten days rather than the validated two years.
- 2024-02-22Open, ClassifiedPackaging process control
GORE VIABIL Short Wire Biliary Endoprosthesis, Product labeled as (1) Catalog Number VSWVH1008, 10 mm x 8 cm; with holes; and (2) Catalog Number VSWVN1008, 10 mm x 8 cm; no holes
Devices without transmural drainage holes may be mislabeled as devices with transmural drainage holes, or vice versa. Potential health impact includes extending procedure time, unplanned device removal, secondary procedure, cholangitis, cholecystitis, and/or pain. The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct which may be obstructed. The endoprosthesis is radially compressed and secured onto the distal end of a catheter-based delivery system for deployment. The catheter provides a means for accessing and implanting the GORE VIABIL Short Wire Biliary Endoprosthesis at the target site in the biliary tract.
- TerminatedProcess change control
GORE VIBIL Biliary Endoprosthesis: stents, drains and dilators for the biliary ducts. Catalogue numbers: VH1008040, VH1010040, VN1010040, VN0808200 - Product Usage: intended for palliation of malignant strictures in the biliary tree.
The Gore post market surveillance team received a complaint that a GORE VIABIL Biliary Endoprosthesis appeared shorter than the labeled length.
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