Gore EXCLUDER AAA Endoprosthesis Recall: Risk of Catheter Component Separation
Gore recalls certain AAA endoprosthesis models due to reports of leading end catheter component separations. Affected products include specific catalog numbers and sizes. Consumers should contact Gore for details.
Use caution until it’s fixed
Firm has received reports of leading end catheter component separations.
Contact the company
What happened, in plain English
W. L. Gore & Associates recalls specific AAA endoprosthesis models because reports indicate leading end catheter components can separate. This could lead to complications during medical procedures if not addressed. Read more at govinfonow.com/recall/66161-gore-excluder-aaa-endoprosthesis-recall-risk-of-catheter-component-separation.
Source Summary by GovInfoNow · govinfonow.com/recall/66161-gore-excluder-aaa-endoprosthesis-recall-risk-of-catheter-component-separation · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0995-2020
Cite this page
“Gore EXCLUDER AAA Endoprosthesis Recall: Risk of Catheter Component Separation.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66161-gore-excluder-aaa-endoprosthesis-recall-risk-of-catheter-component-separation. Based on FDA recall #Z-0995-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0995-2020%22&limit=1).
Why it’s dangerous
The recall is based on reports of leading end catheter components separating. This separation could cause complications during medical procedures, potentially leading to device failure or injury if not properly addressed.
Who’s affected
Patients who have received the recalled endoprosthesis models are most at risk. Healthcare providers using these devices for surgeries may also need to take action.
How to tell if you have this one
Check for catalog numbers listed in the recall, such as PLC*, PLA*, PLL*, RLT23*, RLT26*, RLT28*, RLT31*, RLT35*, HGB*, and CEB*. The products are available in specific sizes and configurations as detailed in the recall notice.
- Brand
Gore- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- 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 number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0995-2020 | 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. | 255861 units |
| Z-0996-2020 | 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. | 23212 units |
What to do — step by step
Contact Gore
Reach out to W. L. Gore & Associates for specific information about your product and instructions on next steps.
How this recall unfolded
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using the product immediately?
No immediate stop is required, but you should contact Gore to determine if your specific model is affected and follow their instructions.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0995-2020 (January 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0995-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.