W. L. Gore & Associates Inc.: Medical Device Recall in 2020 - (Recall #: Z-0996-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)

Product Classification:

Class II

Date Initiated: January 6, 2020

Date Posted: February 12, 2020

Recall Number: Z-0996-2020

Event ID: 84533

Reason for Recall:

Firm has received reports of leading end catheter component separations.

Status: Terminated

Product Quantity: 23212 units

Code Information:

-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.

Distribution Pattern:

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;

Voluntary or Mandated:

Voluntary: Firm initiated