GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis recall
GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)
Why was GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis recalled?
Firm has received reports of leading end catheter component separations.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
-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.
- Product
- GORE¿ EXCLUDER¿ Iliac Branch Endoprosthesis (IBE)
- Recalling firm
- W. L. Gore & Associates Inc.
- 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;
- Recall date
- February 12, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)