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U.S. Department of Health and Human Services

Class 2 Device Recall GORE EXCLUDER AAA Endoprosthesis

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  Class 2 Device Recall GORE EXCLUDER AAA Endoprosthesis see related information
Date Initiated by Firm January 06, 2020
Create Date February 04, 2020
Recall Status1 Open3, Classified
Recall Number Z-0995-2020
Recall Event ID 84533
PMA Number P020004 
Product Classification System, endovascular graft, aortic aneurysm treatment - Product Code MIH
Product GORE¿ EXCLUDER¿ AAA Endoprosthesis
Code Information -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. 
Recalling Firm/
Manufacturer
W. L. Gore & Associates Inc.
32360 N North Valley Pkwy
Phoenix AZ 85085-4228
For Additional Information Contact
623-234-5000
Manufacturer Reason
for Recall
Firm has received reports of leading end catheter component separations.
FDA Determined
Cause 2
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: MPDCustomerCare@wlgore.com 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: medcomplaints@wlgore.com 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;
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA Database PMAs with Product Code = MIH and Original Applicant = W.L. GORE & ASSOCIATES,INC
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