{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 599 } }, "results": [ { "cfres_id": "140324", "product_res_number": "Z-0022-2016", "event_date_initiated": "2015-09-15", "event_date_posted": "2015-10-05", "recall_status": "Terminated", "event_date_terminated": "2016-04-14", "res_event_number": "72245", "product_code": "DTB", "k_numbers": [ "K883743", "K932172", "K940703" ], "product_description": "Medtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components currently registered to the patient. The back of the card lists patient's following physician as well as specific messaging regarding the MR conditional status of the device components, where applicable. This card is provided to the patient by Medtronic after device registration.", "code_info": "no codes on the cards", "firm_fei_number": "2182208", "recalling_firm": "Medtronic Inc. Cardiac Rhythm Disease Management", "address_1": "8200 Coral Sea St NE", "city": "Saint Paul", "state": "MN", "postal_code": "55112-4391", "additional_info_contact": "Medtronic Patient Services\n800-551-5544", "reason_for_recall": "Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional system, when in fact, not all of their implanted leads have been FDA approved as MR Conditional.", "root_cause_description": "Process control", "action": "On September 15, 2015, Medtronic began mailing an Important Medical Device Identification Card Notification letter, including a corrected Medical Device Identification Card, to impacted patients. The letter described the issue, provided a new corrected Identification Card, asked that the old card be destroyed immediately, and to begin using the new card. Patients can contact Medtronic Patient Services at 1-800-551-5544, option 1, followed by option 3, Monday - Friday, 8am - 5pm Central time.", "product_quantity": "777 cards", "distribution_pattern": "US nationwide distribution.", "openfda": { "k_number": [ "K812807", "K790261", "K792321", "K874183", "K890644", "K801792", "K871580", "K844265", "K864428", "K853294", "K842031", "K810494", "K932172", "K862258", "K843707", "K830743", "K890045", "K853398", "K771566", "K890018", "K883743", "K040569", "K790344", "K932892", "K810582", "K901402", "K930876", "K061212", "K861110", "K770214", "K844260", "K925347", "K831997", "K863781", "K813134", "K810333", "K990142", "K910609", "K853568", "K780246", "K781570", "K913204", "K823898", "K820989", "K922042", "K823896", "K961679", "K852915", "K772203", "K853747", "K791377", "K790983", "K911273", "K883602", "K771565", "K871333", "K812816", "K770284", "K895136", "K892528", "K803042", "K883265", "K020669", "K781456", "K823447", "K800347", "K001413", 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"2182208", "9610139", "2648729", "2017865", "3008494315", "3008973940", "1928237", "3013288201", "1720929", "3005029049", "1028232" ], "fei_number": [ "3008988055", "3018094310", "2124215", "3033257494", "3003574398", "1035166", "3009380063", "3000203000", "3016678045", "3006705815", "2183744", "2649622", "2183787", "2182208", "3008377825", "3002806500", "2648729", "2017865", "3008973940", "1928237", "3002618605", "3013288201", "1720929", "3005029049", "1028232" ], "device_name": "Permanent Pacemaker Electrode", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3680", "device_class": "3" } } ] }