{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "159884",
      "product_res_number": "Z-0896-2018",
      "event_date_initiated": "2017-08-09",
      "event_date_created": "2018-03-03",
      "recall_status": "Open, Classified",
      "res_event_number": "78609",
      "product_code": "LKK",
      "pma_numbers": [
        "P860004"
      ],
      "product_description": "Medtronic Synchromed II Model 8637 supplied in 20mL and 40 mL reservoir size and a catheter.\n\nProduct Usage:\nThe implantable Model 8637 SynchroMed II programmable pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a Model 8637 SynchroMed II pump, supplied in 20 ml and 40 ml reservoir sizes, and a catheter. In the United States, the SynchroMed II Pump is specifically approved (indicated) for drugs as referenced in Indications Drug Stability and Emergency Procedures Reference Manual (refer to attached labeling # MA08927A006).",
      "code_info": "US: CFN #:\t         GTIN:\t                             PIN: 8637-20\t00643169508149\t863702012H 8637-40\t00643169508156\t863704012H OUS: CFN#:                   GTIN :                                  PIN: 8637-20\t00643169700901\t863700221K 8637-20\t00643169700918\t863700222K 8637-20\t00643169700925\t863700223K 8637-20\t00643169700932\t863700224K 8637-20\t00643169700949\t863700225K 8637-20\t00643169700956\t863700226K 8637-20\t00643169700963\t863700227K 8637-20\t00643169700970\t863700228K 8637-20\t00643169700987\t863700229K 8637-20\t00643169700994\t863700230K 8637-20\t00643169732247\t863700241K 8637-20\t00643169732254\t863700242K 8637-20\t00643169732261\t863700243K 8637-20\t00643169732278\t863700244K 8637-20\t00643169732285\t863700245K 8637-20\t00643169732292\t863700246K 8637-20\t00643169732308\t863700247K 8637-20\t00643169732315\t863700248K 8637-20\t00643169732322\t863700249K 8637-20\t00643169732339\t863700250K 8637-40\t00643169701007\t863700231K 8637-40\t00643169701014\t863700232K 8637-40\t00643169701021\t863700233K 8637-40\t00643169701038\t863700234K 8637-40\t00643169701045\t863700235K 8637-40\t00643169701052\t863700236K 8637-40\t00643169701069\t863700237K 8637-40\t00643169701076\t863700238K 8637-40\t00643169701083\t863700239K 8637-40\t00643169701090\t863700240K 8637-40\t00643169732346\t863700251K 8637-40\t00643169732353\t863700252K 8637-40\t00643169732360\t863700253K 8637-40\t00643169732377\t863700254K 8637-40\t00643169732384\t863700255K 8637-40\t00643169732391\t863700256K 8637-40\t00643169732407\t863700257K 8637-40\t00643169732414\t863700258K 8637-40\t00643169732421\t863700259K 8637-40\t00643169732438\t863700260K",
      "firm_fei_number": "2182207",
      "recalling_firm": "Medtronic Neuromodulation",
      "address_1": "7000 Central Ave Ne",
      "city": "Minneapolis",
      "state": "MN",
      "postal_code": "55432-3568",
      "additional_info_contact": "Medtronic Technical Services \n800-707-0933",
      "reason_for_recall": "Medtronic implemented a final design change intended to address the motor stall due to corrosion and is recalling devices with the previous design that are not implanted.",
      "root_cause_description": "Device Design",
      "action": "Medtronic sent an Urgent Medical Device Recall letter dated September 2017, to their customers.  The letter identified the affected product, problem and actions to be taken.   Customers were instructed to complete and return the enclosed Customers Confirmation form.  For questions contact Technical Services at 1-888-854-0978.",
      "product_quantity": "27,547 US and 13,025 OUS",
      "distribution_pattern": "US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY",
      "openfda": {
        "pma_number": [
          "P140032",
          "P860004",
          "P080012",
          "P990034",
          "P800036",
          "P890055"
        ],
        "registration_number": [
          "3018094310",
          "2183319",
          "3009183442",
          "3003174284",
          "2523676",
          "3004593495",
          "3015537318",
          "3003120897",
          "2246552",
          "2032227",
          "2182207",
          "3030198397",
          "3007829657",
          "1422634",
          "1526611",
          "1722746",
          "2135338",
          "2124215",
          "3004209178"
        ],
        "fei_number": [
          "3018094310",
          "1000514656",
          "3009183442",
          "3003174284",
          "2523676",
          "3004593495",
          "3015537318",
          "1000306216",
          "3003120897",
          "3004369318",
          "2182207",
          "3030198397",
          "3003166194",
          "3007829657",
          "2246552",
          "1526611",
          "2183319",
          "3005700659",
          "2124215"
        ],
        "device_name": "Pump, Infusion, Implanted, Programmable",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}