Z-0995-2020Class II

GORE EXCLUDER AAA Endoprosthesis

Name: Z-0995-2020 GORE EXCLUDER AAA Endoprosthesis
Creator: W. L. Gore & Associates Inc.
Published: 2020-01-06
License: https://open.fda.gov/license/

W. L. Gore & Associates, Inc. / initiated 2020-01-06 / Terminated / root cause: manufacturing process

FDA source

W. L. Gore & Associates Inc. began a recall of GORE EXCLUDER AAA Endoprosthesis on 2020-01-06. FDA classified it as Class II and gives the reason as "Firm has received reports of leading end catheter component separations". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0995-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-06
Posted: 2020-02-04
Terminated: 2022-08-09
Recalling firm: W. L. Gore & Associates, Inc.
Product: GORE EXCLUDER AAA Endoprosthesis
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Reason for recall: Firm has received reports of leading end catheter component separations.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The recall consists of corrections with no proposed product removal. The correction will consist of: A Medical Device Safety Correction letter sent to US physicians and hospitals and OUS hospitals and Distributors, along with an IFU Summary of Changes document Updates to the products Instruction for Use Updates to physician didactic training Additional manufacturing process error-proofing The firm is also instructing customers to share the letter with others in their hospital or clinic as appropriate, and contact the firm's Customer Service (email: [email protected] or by phone at 800-528- 8763) with any questions related to the letter. Any adverse event should be reported to the manufacturer and the country specific regulatory authorities immediately. To report an event to Recalling Firm, email: [email protected] or contact: USA: +1.800.528.1866, Ext. 44922, +1.928.864.4922, Fax: +1.928.864.4364 China: +86 21 5172 8237, Fax: +86 21 5172 8236 Japan: +81 3 6746 2562, Fax: +81 3 6746 2563 Brazil: +55 11 5502-7953, Fax: +55 11 5502-7965 EMEA: +49 89 4612 3440, Fax: +49 89 4612 43440
Quantity in commerce: 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;
Product codes and lots: -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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0995-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0995-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0996-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04

Product code MIH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)