{ "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": "211346", "product_res_number": "Z-0773-2025", "event_date_initiated": "2024-11-21", "event_date_posted": "2024-12-27", "recall_status": "Open, Classified", "res_event_number": "95845", "product_code": "LKK", "pma_numbers": [ "P860004S404" ], "product_description": "SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900D CLINICIAN TABLET GLOBAL with the A810 CP app version 2.x, CFN CT900D", "code_info": "GTIN: 00763000094027\n00763000077730\n00763000421007\n00763000447090;\nSerial Numbers: 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"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": "Naomi Rodiles\n763-514-2000", "reason_for_recall": "Software issues were identified in application version 2.x.", "root_cause_description": "Under Investigation by firm", "action": "An URGENT: MEDICAL DEVICE CORRECTION notification letter dated November 2024 was sent to customers.\n\nActions\n Share this notice with all those who need to be aware of this issue within your organization and maintain a copy of this notice in your records.\n \nPlease complete and return the Customer Confirmation Form enclosed with this letter, acknowledging that you have received this information. The form may be emailed to neuro.quality@medtronic.com.\n\nAdditional Information\nMedtronic is actively working on a permanent solution and will inform you as soon as it becomes available.\n\nMedtronic is communicating this information to the appropriate regulatory agencies. Adverse events or quality problems experienced with this product should be reported to Medtronic and the FDA MedWatch Adverse Event Reporting program via:\n Medtronic email at RS.NeuAdverseEventReporting@Medtronic.com or Medtronic Technical Services at 1-800-707-0933 weekdays 7:00 AM 6:00 PM CT.\n\n***Update January 2026***\n\nAn URGENT: MEDICAL DEVICE CORRECTION notification letter dated January 2026 was sent to customers.\n\nThe purpose of this letter is to inform you that a new version of the Model A810 SynchroMed Clinician Programmer Application (CP App), v2.0.3320, is now available for installation. This update addresses previously communicated software issues associated with earlier versions used for the Model 8637 SynchroMed II and Model 8667 SynchroMed III infusion pumps.\n\nThese issues were initially communicated to you in the letter enclosed from November 2024. The new version of the A810 CP App resolves these issues.\n\nCustomer Actions:\n\" Download and install A810 CP App v2.0.3320 at your earliest convenience and contact your local Medtronic representative if you have any questions related to the update.\n\" Sign and return the Confirmation Form enclosed with this letter, acknowledging that you have received this information. The form may be emailed to neuro.quality@medtronic.com. Retain a copy of this lette", "product_quantity": "566 systems", "distribution_pattern": "Worldwide - US Nationwide distribution.", "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" } } ] }