Z-0996-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2020
- Initiation Date
- January 6, 2020
- Termination Date
- August 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23212 units
Product Description
GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)
Reason for Recall
Firm has received reports of leading end catheter component separations.
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;
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.