GORE¿ EXCLUDER¿ AAA Endoprosthesis recall
GORE¿ EXCLUDER¿ AAA Endoprosthesis
Why was GORE¿ EXCLUDER¿ AAA 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 Table 1: Device Configurations for Trunk-Ipsilateral Leg Component: RLT231212X*; RLT231214X*; RLT231216X*; RLT231218X*; RLT231412X*; RLT231414X*; RLT231416X*; RLT231418X*; RLT261212X*; RLT261214X*; RLT261216X*; RLT261218X*; RLT261412X*; RLT261414X*, RLT261416X*; RLT261418X*; RLT281212X*; RLT281214X*; RLT281216X*; RLT281218X*; RLT281412X*; RLT281414X*; RLT281416X*; RLT281418X*; RLT311413X*; RLT311415X*; RLT311417X*; RLT351414X*; RLT351416X*; RLT351418X*; Table 2: Discontinued Device Configurations for Trunk-Ipsilateral Leg Component: RMT231212X*; RMT231214X*; RMT231216X*; RMT231218X*; RMT231412X*; RMT231414X*; RMT231416X*; RMT231418X*; RMT261212X*; RMT261214X*; RMT261216X*; RMT261218X*; RMT261412X*; RMT261414X*; RMT261416X*; RMT261418X*; RMT281212X*; RMT281214X*; RMT281216X*; RMT281218X*; RMT281412X*; RMT281414X*; RMT281416X*; RMT281418X*; RMT311413X*; RMT311415X*; RMT311417X*; PXT231212X*; PXT231214X*; PXT231216X*; PXT231218X*; PXT231412X*; PXT231414X*; PXT231416X*; PXT231418X*; PXT261212X*; PXT261214X*; PXT261216X*; PXT261218X*; PXT261412X*; PXT261414X*; PXT261416X*; PXT261418X*; PXT281212X*; PXT281214X*; PXT281216X*; PXT281218X*; PXT281412X*; PXT281414X*; PXT281416X*; PXT281418X*; PXT311413X*; PXT311415X*; PXT311417X* PXT311415X*; PXT311417X*. Table 3: Device Configurations for Contralateral Leg Component: PLC121000X*; PLC121200X*; PLC121400X*; PLC141000X*; PLC141200X*; PLC141400X*; PLC161000X*; PLC161200X*; PLC161400X*; PLC181000X*; PLC181200X*; PLC181400X*; PLC201000X*; PLC201200X*; PLC201400X*; PLC231000X*; PLC231200X*; PLC231400X*; PLC271000X*; PLC271200X*; PLC271400X* Table 4: Discontinued Device Configurations for Contralateral Leg Component: PXC121000X*; PXC121200X*; PXC121400X*; PXC141000X*; PXC141200X*; PXC141400X*; PXC161000X*; PXC161200X*; PXC161400X*; PXC181000X*; PXC181200X*; PXC181400X*; PXC201000X*; PXC201200X*; PXC201400X*; PXC231000X*; PXC231200X*; PXC231400X*; PXC271000X*; PXC271200X*; PXC271400X*. Table 5: Device Configurations for Iliac Extender Component: PLL161007X*; PLL161207X*; PLL161407X*. Table 6: Discontinued Device Configurations for Iliac Extender Component: PXL161007X*; PXL161207X*;PXL161407X*. Table 7: Device Configurations for Aortic Extender Component: PLA230300X*; PLA260300X*; PLA280300X*; PLA320400X*; PLA360400X*. Table 8: Discontinued Device Configurations for Aortic Extender Component: PXA230300X*; PXA260300X*; PXA280300X*; PXA320400X*. -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¿ AAA Endoprosthesis
- Recalling firm
- W. L. Gore & Associates Inc.
- Quantity
- 255861 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)