FDA Medical Device Recalls (openFDA)
W. L. Gore & Associates Inc.: GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)
- Recall number
- Z-0996-2020
- Recalling firm
- W. L. Gore & Associates Inc.
- Product
- GORE EXCLUDER Iliac Branch Endoprosthesis (IBE)
- Status
- Terminated
- Initiated
- 2020-01-06
- Posted
- not on file
- Terminated
- 2022-08-09
- Reason
- Firm has received reports of leading end catheter component separations.
- Root cause
- Employee error
- Action
- The recall consists of corrections with no proposed product removal. The correction will consist of: A Medical Device Safety Correction letter sent to US physicians and hospitals and OUS hospitals and Distributors, along with an IFU Summary of Changes document Updates to the products Instruction for Use Updates to physician didactic training Additional manufacturing process error-proofing The firm is also instructing customers to share the letter with others in their hospital or clinic as appropriate, and contact the firm's Customer Service (email: MPDCustomerCare@wlgore.com or by phone at 800-528- 8763) with any questions related to the letter. Any adverse event should be reported to the manufacturer and the country specific regulatory authorities immediately. To report an event to Recalling Firm, email: medcomplaints@wlgore.com or contact: USA: +1.800.528.1866, Ext. 44922, +1.928.864.4922, Fax: +1.928.864.4364 China: +86 21 5172 8237, Fax: +86 21 5172 8236 Japan: +81 3 6746 2562, Fax: +81 3 6746 2563 Brazil: +55 11 5502-7953, Fax: +55 11 5502-7965 EMEA: +49 89 4612 3440, Fax: +49 89 4612 43440
- 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;
- Lot, serial or model codes
- -Catalog numbers PLC*, PLA*, PLL*, RLT23*, RLT26*, RLT28*, RLT31*, RLT35*, HGB*, and CEB* *= size -not specific to any particular lot or serial numbers. For full details of affected products see 806 Attachment 1 - Catalog Numbers and Sizes.
- 510(k) numbers
- not on file
- PMA numbers
- ["P020004"]
- Product code
- MIH
- Firm FEI
- 3007284313
- Firm city
- Phoenix
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28