{ "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": "2026-09-24", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "214616", "product_res_number": "Z-2127-2025", "event_date_initiated": "2025-06-17", "event_date_posted": "2025-07-17", "recall_status": "Open, Classified", "res_event_number": "97125", "product_code": "KRG", "pma_numbers": [ "P890003", "P980016", "P980035", "P010015", "P010031", "P150033" ], "product_description": "Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: \n1.\tAzure Astra application, Software Model Number D00U003; \n2.\tPercepta Serena Solara application, Software Model Number D00U004; \n3.\tCobalt Crome application, Software Model Number D00U005; \n4.\tMicra VR application, Software Model Number D00U006; \n5.\tMicra AV application, Software Model Number D00U007; \n6.\tViva Consulta Syncra Advisa Ensura application, Software Model Number D00U008; \n7.\tClaria Amplia Compia application, Software Model Number D00U009; \n8.\tEvera MRI application, Software Model Number D00U010; \n9.\tVisia AF application, Software Model Number D00U011; \n10.\tViva Brava Evera application, Software Model Number D00U012; \n11.\tMicra VR2 AV2 application, Software Model Number D00U022.", "code_info": "1.\tSoftware Model Number, D00U003, GTIN 00763000002039, Updated Software Version 6.5.5; \n2.\tSoftware Model Number, D00U004, GTIN 00763000002046, Updated Software Version 6.5.5; \n3.\tSoftware Model Number, D00U005, GTIN 00763000002053, Updated Software Version 9.5.2; \n4.\tSoftware Model Number, D00U006, GTIN 00763000397852, Updated Software Version 4.4.6; \n5.\tSoftware Model Number, D00U007, GTIN 00763000397869, Updated Software Version 4.4.6; \n6.\tSoftware Model Number, D00U008, GTIN 00763000397876, Updated Software Version 3.5.5; \n7.\tSoftware Model Number, D00U009, GTIN 00763000397883, Updated Software Version 3.4.2; \n8.\tSoftware Model Number, D00U010, GTIN 00763000397890, Updated Software Version 3.4.2;\n9.\tSoftware Model Number, D00U011, GTIN 00763000397906, Updated Software Version 3.4.2;\n10.\tSoftware Model Number, D00U012, GTIN 00763000397913, Updated Software Version 3.4.2;\n11.\tSoftware Model Number, D00U022, GTIN 00763000544300, Updated Software Version 3.7.5.", "firm_fei_number": "2182208", "recalling_firm": "Medtronic, Inc.", "address_1": "8200 Coral Sea St Ne", "city": "Mounds View", "state": "MN", "postal_code": "55112-4391", "additional_info_contact": "Technical Services\n800-929-4043", "reason_for_recall": "A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous message indicates an electrical reset has occurred. However, no reset has actually occurred and there are no parameter changes or loss of diagnostics. Prior to this software update, if an erroneous SmartSync message was displayed, confusion regarding the message could have caused a clinician to consider an unnecessary system revision. Medtronic has received 39 reports of this display error with two instances of unnecessary device explant through 30 April 2025.", "root_cause_description": "Software design", "action": "Medtronic issued an URGENT MEDICAL DEVICE CORRECTION NOTIFICATION to its consignees on 06/18/2025 via UPS 2nd day delivery. The notice announced that a software update was available for the Medtronic CareLink SmartSync Device Manager (SmartSync), explained the issue which the update was correcting, risk, and requested the following: \nCustomer Actions:\n\" Update SmartSync (to version 4.2.3 or higher). Refer to release notes provided by your local Medtronic representative for update instructions. If needed, Medtronic representatives are available to work with you to install or update the SmartSync application(s) on your tablet. See Appendix for instructions on how to verify the software update is complete.\n\" Sign and return the enclosed confirmation form and share this notice with those who need to be aware within your organization or with any organization where SmartSync may be in use. Questions regarding this information should be directed to the local Medtronic Representative or Medtronic Programmer Technical Services at 800-638-1991, Option 1.", "product_quantity": "3909 units", "distribution_pattern": "Worldwide", "openfda": { "k_number": [ "K812761", "K863046", "K810552", "K860584", "K771855", "K812813", "K811217", "K844485", "K933278", "K860546", "K792580", "K842364", "K791419", "K844483", "K880738", "K820230", "K790220", "K864712", "K780175", "K884522", "K863045", "K882429", "K800376", "K844484", "K871986" ], "pma_number": [ "P880086", "P890003", "P880006", "P010031", "P830045", "P900070", "P910077", "P940031" ], "device_name": "Programmer, Pacemaker", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3700", "device_class": "3", "registration_number": [ "2030624", "3008483389", "3009380063", "3003120897", "2135338", "2182208", "9610139", "3033257494", "2032521", "3013288201", "3015453963", "3018094310", "3008494315", "2017865", "9616693", "2124215", "3005334138", "3006705815", "2649622", "1028232", "9614453", "3011120183" ], "fei_number": [ "3008483389", "3000206435", "3009380063", "3003120897", "3005700659", "2182208", "3002807576", "3033257494", "3002618605", "3003574398", "3013288201", "3015453963", "3002806500", "3018094310", "2017865", "2124215", "3005334138", "3006705815", "2649622", "1028232", "3008377825", "3011120183" ] } } ] }