{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "158354", "product_res_number": "Z-0399-2018", "event_date_initiated": "2017-07-14", "event_date_created": "2018-01-19", "recall_status": "Terminated", "event_date_terminated": "2024-06-28", "res_event_number": "77964", "product_code": "NVZ", "pma_numbers": [ "P890003" ], "product_description": "MyCareLink Patient Monitors.\n\nIt is intended for used with a compatible Medtronic patient implanted heart device. The monitor is an external electronic device that interfaces with Medtronic implanted heart devices and a telecommunications connection to transmit stored implanted heart device data to the physician or clinician.", "code_info": "Model (UPN/GTIN): 24950 (00643169292284, 00643169292345, 00643169292260, 00643169292529, 00643169292208, 00643169292192, 00643169292222, 00643169292239, 00643169292321, 00643169292215, 00643169292246, 00643169409132, 00643169292253, 00643169292277, 00643169292291, 00643169292307, 00643169292314, 00643169292338); 24950D (643169467163, 00643169441484, 00643169441101, 00643169367173, 00643169367227, 00643169367159, 00643169409156, 00643169367296, 00643169367302, 00643169367258, 00643169367180, 00643169367166, 00643169367210, 00643169367289, 00643169409149, 00643169367197, 00643169367142, 00643169367241, 00643169367203); 24950D1 (00643169486744); 24950E (00643169493667, 00643169493681, 00643169493698, 00643169493674, 00643169451988, 00643169452015, 00643169452107, 00643169452039, 00643169452121, 00643169452008,  00643169452145, 00643169452046, 00643169452022, 00643169452053, 00643169452138, 00643169452060, 00643169451995, 00643169452114, 00643169452152, 00643169452077, 00643169452084, 00643169452091); 24950F (00643169545274, 00643169552074); 24950G (00643169663039 00643169624337, 00643169599987, 00643169599994, 00643169624368, 00643169624351, 00643169624344, 00643169552104); 24950GLQ (00643169552289, 00643169552050, 00643169552067); 24950J (00643169840591, 00643169658011, 00643169658066, 00643169657892, 00643169658073, 00643169786196, 00643169658059, 00643169658028, 00643169658004, 00643169657908, 00643169657915, 00643169657946, 00643169657953, 00643169657960, 00643169657977, 00643169657984, 00643169657991, 00643169657922, 00643169657939, 00643169658042, 00643169658080, 00643169658097, 00643169657885, 00643169705746, 00643169658035); 24950JLQ (00643169658127, 00643169658134, 00643169658141, 00643169947115, 00643169705753); 24950K (00643169725270, 00643169725324, 00643169725201, 00643169725355, 00643169725331, 00643169725317, 00643169725287, 00643169725263, 00643169725294, 00643169725218, 00643169725232, 00643169725249, 00643169725256, 00643169725225, 00643169725300, 00643169725348, 00643169725195); 24950KLQ (00643169725362, 00643169725379, 00643169725386)", "firm_fei_number": "2182208", "recalling_firm": "Medtronic Inc., Cardiac Rhythm and Heart Failure", "address_1": "8200 Coral Sea St NE", "city": "Mounds View", "state": "MN", "postal_code": "55112-4391", "additional_info_contact": "Ryan Mathre\n763-514-9625", "reason_for_recall": "Patients monitored on two (2) or more implanted Medtronic heart devices in the Medtronic CareLink Network may have potential impact on the ability to remotely monitor the patient's heart devices. Potential impacts could lead to missed CareAlert notifications or device reports.", "root_cause_description": "Error in labeling", "action": "Customers were notified via letter on 07/14/2017. Medtronic communicated that an updated Clinician Instructions for Use has been released with the following updated information: In patients with more than one Medtronic implanted hear device, device data may not be able to transmit from any of the implanted devices to the physician via the Monitor; The patient could potentially transmit device data unintentionally from one of the implanted heart devices when attempting to transmit from another device implanted in the same patient; and a Medtronic Programmer can be used to obtain data from each implanted heart device. Instructions included to ensure all appropriate personnel are notified of this correction.", "product_quantity": "1,519,984 enrollments total", "distribution_pattern": "Domestic: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, \n\nInternationally: Austria, Belgium, Brunei, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lithuania, Malaysia, Malta, Netherlands, Norway, Philippines, Poland, Portugal, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, United Kingdom", "openfda": { "pma_number": [ "P910023", "P990001", "P880038", "P950029", "P960013", "P010031", "P880086", "P950037", "P890003", "P830045", "P980035", "P880006", "P900070", "P970012", "P010015", "P930022" ], "registration_number": [ "3015453963", "3008159616", "3008483389", "3018094310", "3013288201", "3003120897", "2017865", "3009144177", "2182208", "3013500228", "3005334138", "3006705815", "2124215", "3008494315", "9614453", "2135338", "2649622", "3004209178", "3008973940", "1028232", "3013596024", "3012552532", "2133641", "1220452", "2024024", "3002806603", "2030624", "3004593495", "3033257494", "2032521", "3009380063", "3011120183", "9610139", "3005941719", "1000165971" ], "fei_number": [ "3005700659", "3015453963", "3003574398", "3008159616", "3008483389", "3018094310", "3013288201", "3003120897", "2017865", "3009144177", "2182208", "3013500228", "3005334138", "3006705815", "2124215", "3002807576", "2649622", "3000203466", "3008973940", "3004369318", "1028232", "3013596024", "3012552532", "3002806500", "1220452", "2024024", "3000206435", "3002806603", "3004593495", "3033257494", "3009380063", "3008377825", "3002807111", "3011120183", "1000165971" ], "device_name": "Pulse Generator, Permanent, Implantable", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ] }