{ "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": 1 } }, "results": [ { "cfres_id": "105436", "product_res_number": "Z-0430-2012", "event_date_initiated": "2011-09-23", "event_date_posted": "2012-01-11", "recall_status": "Terminated", "event_date_terminated": "2012-04-10", "res_event_number": "60134", "product_code": "DXY", "pma_numbers": [ "P030035", "P880086" ], "product_description": "Anthem CRT-P models PM3110 and PM3210\n\nSt. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.", "code_info": "Models PM3110, 3112, 3210,3212 (Anthem) and    All lots and serial numbers", "firm_fei_number": "2017865", "recalling_firm": "St Jude Medical CRMD", "address_1": "15900 Valley View Ct", "city": "Sylmar", "state": "CA", "postal_code": "91342-3577", "additional_info_contact": "818-362-6822", "reason_for_recall": "St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements. These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. The out of range readings are concluded as false.", "root_cause_description": "Pending", "action": "The firm, St. Jude Medical, sent an \"IMPORTANT PRODUCT FIELD CORRECTION\" letter dated September 22, 2011 to its customers by FedEx priority overnight service for planned receipt on September 23, 2011. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed that in order to prevent a false reading, a new programmer software version (12.1.0.1) is available. This software when used to interrogate an Accent DR or Anthem CRT-P pacemaker will eliminate the potential for this anomaly to occur. The onetime upgrade is performed automatically on affected devices and will not change the operation of the implanted device. A St. Jude Medical Sales Representative will assist the customers in loading the new programmer software onto their Merlin programmer. \n\nCustomers with questions or concerns, can contact their local St. Jude Medical representative or their Technical services department at (800) 722-3774.", "product_quantity": "14,000 units", "distribution_pattern": "Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Australia, Asia Pacific, Belgium, Bulgaria, Canada, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Iran, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latin America, Lebanon, Malaysia, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, UK, and U.A.E.", "openfda": { "k_number": [ "K792052", "K781738", "K820939", "K760669", "K841635", "K772241", "K860922", "K800838", "K853651", "K863898", "K903081", "K810036", 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"P890003", "P900070", "P970012", "P880038", "P910023", "P990001", "P910020", "P880006", "P880086", "P870054", "P060027", "P960004", "P980049", "P950037", "P890039", "P140033" ], "registration_number": [ "3003120897", "3005334138", "3018094310", "2032521", "2133641", "2135338", "2124215", "3033257494", "1000165971", "3002806603", "3009380063", "2024024", "3008159616", "3006705815", "3008483389", "2649622", "2182208", "9610139", "2648729", "3004593495", "2017865", "3008494315", "3008973940", "3013288201", "9614453", "3012552532", "1028232", "3004209178" ], "fei_number": [ "3003120897", "3005334138", "3018094310", "2124215", "3033257494", "1000165971", "3005700659", "3003574398", "3002806603", "3002807576", "3009380063", "2024024", "3008159616", "3004369318", "3006705815", "3008483389", "2649622", "2182208", "3008377825", "3002806500", "2648729", "3004593495", "2017865", "3008973940", "3013288201", "3000203466", "3012552532", "1028232" ], "device_name": "Implantable Pacemaker Pulse-Generator", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3610", "device_class": "3" } } ] }