{
  "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": "2026-06-04",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "219579",
      "product_res_number": "Z-2160-2026",
      "event_date_initiated": "2026-04-22",
      "event_date_posted": "2026-05-22",
      "recall_status": "Open, Classified",
      "res_event_number": "98729",
      "product_code": "MIH",
      "pma_numbers": [
        "P200045"
      ],
      "product_description": "RelayPro Thoracic Stent-Graft System (various sizes)\nReference numbers: 28-N4-32-104-32U\t28-N4-32-164-28U\t28-N4-32-164-32U\t28-N4-32-209-28U\t28-N4-32-209-32U\t28-N4-32-259-32U\t28-N4-34-109-34U\t28-N4-34-154-30U\t28-N4-34-154-34U\t28-N4-34-209-30U\t28-N4-34-209-34U\t28-N4-34-259-34U\t28-N4-36-109-36U\t28-N4-36-154-32U\t28-N4-36-154-36U\t28-N4-36-199-32U\t28-N4-36-199-36U\t28-N4-36-259-36U\t28-N4-38-109-38U\t28-N4-38-154-34U\t28-N4-38-154-38U\t28-N4-38-199-34U\t28-N4-38-199-38U\t28-N4-38-259-38U\t28-N4-40-114-40U\t28-N4-40-154-36U\t28-N4-40-154-40U\t28-N4-40-204-36U\t28-N4-40-204-40U\t28-N4-40-259-40U\t28-N4-42-114-42U\t28-N4-42-159-38U\t28-N4-42-159-42U\t28-N4-42-204-38U\t28-N4-42-204-42U\t28-N4-42-259-42U\t28-N4-44-114-44U\t28-N4-44-164-40U\t28-N4-44-164-44U\t28-N4-44-209-40U\t28-N4-44-209-44U\t28-N4-44-259-40U\t28-N4-44-259-44U\t28-N4-46-114-46U\t28-N4-46-164-42U\t28-N4-46-164-46U\t28-N4-46-209-42U\t28-N4-46-209-46U\t28-N4-46-259-42U",
      "code_info": "All Lots/(Ref Number/Proximal Diameter/DI)28-N4-32-104-32U/\t32/\t(01)00843576150461;\n28-N4-32-164-28U/\t32/\t(01)00843576150959;\n28-N4-32-164-32U/\t32/\t(01)00843576150591;\n28-N4-32-209-28U/\t32/\t(01)00843576151055;\n28-N4-32-209-32U/\t32/\t(01)00843576150720;\n28-N4-32-259-32U/\t32/\t(01)00843576150850;\n28-N4-34-109-34U/\t34/\t(01)00843576150478;\n28-N4-34-154-30U/\t34/\t(01)00843576150966;\n28-N4-34-154-34U/\t34/\t(01)00843576150607;\n28-N4-34-209-30U/\t34/\t(01)00843576151062;\n28-N4-34-209-34U/\t34/\t(01)00843576150737;\n28-N4-34-259-34U/\t34/\t(01)00843576150867;\n28-N4-36-109-36U/\t36/\t(01)00843576150485;\n28-N4-36-154-32U/\t36/\t(01)00843576150973;\n28-N4-36-154-36U/\t36/\t(01)00843576150614;\n28-N4-36-199-32U/\t36/\t(01)00843576151079;\n28-N4-36-199-36U/\t36/\t(01)00843576150744;\n28-N4-36-259-36U/\t36/\t(01)00843576150874;\n28-N4-38-109-38U/\t38/\t(01)00843576150492;\n28-N4-38-154-34U/\t38/\t(01)00843576150980;\n28-N4-38-154-38U/\t38/\t(01)00843576150621;\n28-N4-38-199-34U/\t38/\t(01)00843576151086;\n28-N4-38-199-38U/\t38/\t(01)00843576150751;\n28-N4-38-259-38U/\t38/\t(01)00843576150881;\n28-N4-40-114-40U/\t40/\t(01)00843576150508;\n28-N4-40-154-36U/\t40/\t(01)00843576150997;\n28-N4-40-154-40U/\t40/\t(01)00843576150638;\n28-N4-40-204-36U/\t40/\t(01)00843576151093;\n28-N4-40-204-40U/\t40/\t(01)00843576150768;\n28-N4-40-259-40U/\t40/\t(01)00843576150898;\n28-N4-42-114-42U/\t42/\t(01)00843576150515;\n28-N4-42-159-38U/\t42/\t(01)00843576151000;\n28-N4-42-159-42U/\t42/\t(01)00843576150645;\n28-N4-42-204-38U/\t42/\t(01)00843576151109;\n28-N4-42-204-42U/\t42/\t(01)00843576150775;\n28-N4-42-259-42U/\t42/\t(01)00843576150904;\n28-N4-44-114-44U/\t44/\t(01)00843576150522;\n28-N4-44-164-40U/\t44/\t(01)00843576151017;\n28-N4-44-164-44U/\t44/\t(01)00843576150652;\n28-N4-44-209-40U/\t44/\t(01)00843576151116;\n28-N4-44-209-44U/\t44/\t(01)00843576150782;\n28-N4-44-259-40U/\t44/\t(01)00843576151215;\n28-N4-44-259-44U/\t44/\t(01)00843576150911;\n28-N4-46-114-46U/\t46/\t(01)00843576150539;\n28-N4-46-164-42U/\t46/\t(01)00843576151024;\n28-N4-46-164-46U/\t46/\t(01)00843576150669;\n28-N4-46-209-42U/\t46/\t(01)00843576151123;\n28-N4-46-209-46U/\t46/\t(01)00843576150799;\n28-N4-46-259-42U/\t46/\t(01)00843576151222",
      "firm_fei_number": "1000135961",
      "recalling_firm": "Bolton Medical Inc.",
      "address_1": "799 International Pkwy",
      "city": "Sunrise",
      "state": "FL",
      "postal_code": "33325-6220",
      "additional_info_contact": "Kimberly Feitl\n954-838-9699",
      "reason_for_recall": "Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On April 22, 2026 Bolton Medical Inc. (subsidiary of Terumo Aortic). Bolton Medical ask consignees to take the following actions: \n\n1. Consider alternative stent-graft options prior to use of the RelayPro devices impacted until the root cause evaluation is completed and effective mitigation measures are in place.\n2. Inform all users of Relay Pro of the additional guidance for managing cases where the stent graft cannot be released from the delivery system.\n3. Please post a copy of this notification where the devices are stored and keep with the IFU.\n4. Complete acknowledgment form acknowledging receipt and communication of this medical device correction notice. Return to Terumo6732@sedgwick.com.\n5. If devices have been transferred to another facility, please provide them with a copy of the notification and instruct them to follow the actions in this section.",
      "distribution_pattern": "Worldwide - distribution in the US Territory of Puerto Rico and the countries of Argentina, Chile, Canada, Colombia, Mexico, United Kingdom.",
      "openfda": {
        "pma_number": [
          "P100021",
          "P190015",
          "P120006",
          "P040002",
          "P040043",
          "P210032",
          "P070007",
          "P180001",
          "P110038",
          "P110032",
          "P150002",
          "P200045",
          "P990017",
          "P020004",
          "P140016",
          "P070016",
          "P100040",
          "P020018",
          "P070027",
          "P990020",
          "P200030"
        ],
        "registration_number": [
          "3007738736",
          "3011063223",
          "3007284313",
          "2030624",
          "2247858",
          "3008307705",
          "3002807314",
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          "3004497303",
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          "1721676",
          "2017233",
          "9617601",
          "1721686",
          "3013164176",
          "9710641",
          "3009380063",
          "2953200",
          "9680271",
          "1219313",
          "3005580113",
          "3009526575",
          "2011171",
          "1820334"
        ],
        "fei_number": [
          "3007738736",
          "3011063223",
          "3007284313",
          "3008307705",
          "3007530363",
          "3002807314",
          "3012102437",
          "3008011247",
          "3016521833",
          "3003565456",
          "3011324393",
          "3003678543",
          "3002534070",
          "3006131984",
          "1000114185",
          "3004497303",
          "3002808486",
          "3005562917",
          "1721676",
          "2017233",
          "3000206435",
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          "3001452571",
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          "3009380063",
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          "1219313",
          "3005580113",
          "3009526575",
          "3003528016",
          "2011171",
          "1820334",
          "3003259710"
        ],
        "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}