Class II — W. L. Gore & Associates Inc.
| Recalling firm | W. L. GORE & ASSOCIATES, INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Firm has received reports of leading end catheter component separations. |
| Product | GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE) |
| Quantity | 23212 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; |
| Initiated | 2020-01-06 |
| Classified | 2020-02-04 |
| Terminated | 2022-08-09 |
| Recall number | Z-0996-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — W. L. Gore & Associates Inc. (Z-0996-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84533/
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