{
  "meta": {
    "disclaimer": "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. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Phoenix",
      "state": "AZ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "84533",
      "recalling_firm": "W. L. Gore & Associates Inc.",
      "address_1": "32360 N North Valley Pkwy",
      "address_2": "N/A",
      "postal_code": "85085-4228",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "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": "Z-0995-2020",
      "product_description": "GORE¿ EXCLUDER¿ AAA Endoprosthesis",
      "product_quantity": "255861 units",
      "reason_for_recall": "Firm has received reports of leading end catheter component separations.",
      "recall_initiation_date": "20200106",
      "center_classification_date": "20200204",
      "termination_date": "20220809",
      "report_date": "20200212",
      "code_info": "-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."
    }
  ]
}