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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

W. L. Gore & Associates Inc.: Firm has received reports of leading end catheter component separations.

Agency Publication Date: February 4, 2020
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Affected Products

Product: GORE¿ EXCLUDER¿ AAA Endoprosthesis

-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¿ Iliac Branch Endoprosthesis (IBE)

-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.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84533
Status: Resolved
Manufacturer: W. L. Gore & Associates Inc.
Manufactured In: United States
Units Affected: 2 products (255861 units; 23212 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.