GORE¿ EXCLUDER¿ AAA Endoprosthesis
Reported: February 12, 2020 Initiated: January 6, 2020 #Z-0995-2020
Product Description
GORE¿ EXCLUDER¿ AAA Endoprosthesis
Reason for Recall
Firm has received reports of leading end catheter component separations.
Details
- Recalling Firm
- W. L. Gore & Associates Inc.
- Units Affected
- 255861 units
- Distribution
- US: OUS: Australia; Austria; Canada; China; Taiwan; United Arab Emirates; Argentina; Brazil; Switzerland; Chile; Colombia; Costa Rica; Czechia; Spain; Greece; Croatia; Hungary; Ireland; Israel; Italy; United Kingdom; Lebanon; Mexico; New Zealand; Panama; Poland; Saudi Arabia; Slovenia; Germany; Netherlands; Norway; Finland; France; Sweden; Monaco;
- Location
- Phoenix, AZ
Frequently Asked Questions
What product was recalled? ▼
GORE¿ EXCLUDER¿ AAA Endoprosthesis. Recalled by W. L. Gore & Associates Inc.. Units affected: 255861 units.
Why was this product recalled? ▼
Firm has received reports of leading end catheter component separations.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 12, 2020. Severity: Moderate. Recall number: Z-0995-2020.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11