{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "42405", "product_res_number": "Z-0188-06", "event_date_initiated": "2005-09-22", "event_date_posted": "2005-09-24", "recall_status": "Terminated", "event_date_terminated": "2006-12-27", "res_event_number": "33491", "product_code": "DXY", "product_description": "Guidant INSIGNIA I Ultra family of pacemakers includes the following: SR (models1190); and DR (models1290, 1291). Intermedics NEXUS I Ultra family of pacemakers includes the following: SR (model 1390) and DR (model 1490, 1491). The INSIGNIA I Ultra pacemakers are multiprogrammable pacemakers from Guidant. The NEXUS I Ultra pacemakers are multiprogrammable pacemakers from Intermedics. The family consists of both dual-chamber and single-chamber models, offering adaptive-rate therapy and providing various levels of therapeutic and diagnostic functionality. These pacemakers include ventricular Automatic Capture which automatically measures the ventricular pacing threshold and adjusts the pacing output to 0.5 V above the measured threshold. Two sensors are available: these adapt the pacing rate to the patient''s changing metabolic demand. Minute ventilation responds to changes in respiration, and the accelerometer responds to patient activity (motion). INSIGNIA and NEXUS I Ultra models can use either the accelerometer or minute ventilation sensor, or a blend of both accelerometer and minute ventilation.\nSterilized with gaseous ethylene oxide. Guidant Corporation, Cardiac Rhythm Management, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. or Intermedics, Inc., 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA.", "code_info": "INSIGNIA Ultra SR (model 1190) serial no. 889963 - 891468; NEXUS Ultra SR (model 1390) serial no. 100007 - 100034. INSIGNIA Ultra DR (model 1290) serial no. 100678 - 105229; (model 1291) serial no. 100279 - 100913; NEXUS Ultra DR (model 1490) serial no. 100007, 100008, 100009, 100013, 100014, 100015, 100016, 100017, 100018; (model 1491) serial no. 100007, 100008, 100009, 100010, 100013, 100015, 100016, 100017, 100018.", "firm_fei_number": "2124215", "recalling_firm": "Guidant Corporation", "address_1": "4100 Hamline Ave N", "city": "Saint Paul", "state": "MN", "postal_code": "55112-5798", "reason_for_recall": "A failure mode occurring at a low rate, has been identified within the INSIGNIA and NEXUS families of implantable pacemakers. Device behaviors which may be observed include: Intermittent or permanent loss of pacing output without warning, intermittent or permanent loss of telemetry and appearance of a reset warning message upon interrogation.", "root_cause_description": "Other", "action": "Important Medical Device Safety Information & Corrective Action , dated 09/22/05 was sent to all affected physicians. This letter explained the failure mode, what devices are affected and gave recommendations. A press release was issued on 09/22/05.", "product_quantity": "1281", "distribution_pattern": "Nationwide and Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Denmark, \nDominican Republic, Ecuador, Finland, France, Germany, Guadeloupe, \nHong Kong, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, \nLuxembourg, Malaysia, Mexico, Monaco, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Polynesia, Portugal, Qatar, \nReunion, Saudi Arabia, Singapore, South Africa, Spain, Sweden, \nSwitzerland, Thailand, Turkey, United Kingdom and Venezuela", "openfda": { "k_number": [ "K853771", "K771262", "K853400", "K790452", "K830390", "K894267", "K950210", "K874394", "K770135", "K940039", "K863365", "K770715", "K781426", "K896809", "K840748", "K880898", "K811350", "K782146", "K904941", "K780780", "K790428", "K834096", "K861719", "K852430", "K873158", "K841230", "K881837", "K790566", "K811123", "K813534", "K780453", "K791751", "K833198", "K844794", 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"2032521", "3005334138", "2017865", "3018094310", "2649622", "3003120897", "3008494315", "1028232", "3009380063", "3008483389", "1000165971", "3008973940", "2133641", "3004209178", "3013288201", "3006705815", "2182208", "2024024", "2124215", "2135338", "3033257494", "9614453", "2648729", "3012552532", "3002806603" ], "fei_number": [ "3004593495", "3008159616", "3004369318", "3005334138", "2017865", "3018094310", "2649622", "3003120897", "1028232", "3002807576", "3009380063", "3003574398", "3008483389", "1000165971", "3008973940", "3000203466", "3013288201", "3006705815", "3005700659", "2182208", "2024024", "2124215", "3002806500", "3033257494", "3008377825", "2648729", "3012552532", "3002806603" ], "device_name": "Implantable Pacemaker Pulse-Generator", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3610", "device_class": "3" } } ] }