{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 3 } }, "results": [ { "cfres_id": "194667", "product_res_number": "Z-1495-2022", "event_date_initiated": "2022-06-17", "event_date_created": "2022-08-02", "recall_status": "Open, Classified", "res_event_number": "90530", "product_code": "DXY", "pma_numbers": [ "P880086", "P140033", "P030035" ], "product_description": "Merlin PCS 3650 programmer Model 3330 software", "code_info": "Software Model 3330 v26.0.1 rev 1 or earlier; UDI/DI 05414734509725", "firm_fei_number": "2017865", "recalling_firm": "St. Jude Medical, Cardiac Rhythm Management Division", "address_1": "15900 Valley View Ct", "city": "Sylmar", "state": "CA", "postal_code": "91342-3577", "additional_info_contact": "Ms. Alicia Swanson\n408-845-3427", "reason_for_recall": "There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain pacemakers.", "root_cause_description": "Software design", "action": "On June 16, 2022 Abbott issued a \"Medical Device Correction\" via: XXXX to affected consignees. The customer notification ask consignees to take the following action: \n\n1. Prophylactic device replacement is not recommended, as device functionality, actual longevity, and ERI indicator are not impacted (device functionality remains normal and within specifications).\n\n2. Routine follow-up should remain as per local standard of care and clinical protocol, and ERI should continue to serve as an indicator of the need for device replacement scheduling.\n\n3. Please direct any questions about device longevity to Abbott Technical Support at 1-800-722-3774 (U.S.).\n\n4.Upon programmer software / remote monitoring software update, the improved longevity estimate will be displayed at the patient s next interrogation. Please note that until programmers are updated, a difference in longevity estimates between programmers and remote monitoring (Merlin.net) may be observed.", "product_quantity": "29,996 programs", "distribution_pattern": "US: AK\tAL\tAR\tAZ\tCA\tCO\tCT\tDC\tDE\tFL\tGA\tHI\tIA\tID\tIL\tIN\tKS\tKY\tLA\tMA\tMD\tME\tMI\tMN\tMO\tMS\tMT\tNC\tND\tNE\tNH\tNJ\tNM\tNV\tNY\tOH\tOK\tOR\tPA\tPR\tRI\tSC\tSD\tTN\tTX\tUT\tVA\tVI\tVT\tWA\tWI\tWV\tWY\t, Guam\n\nOUS: ALBANIA\tALGERIA\tANGOLA\tArgentina\tARMENIA\tAustralia\tAUSTRIA\tAZERBAIJAN\tBAHRAIN\tBangladesh\tBELGIUM\tBENIN\tBOLIVIA\tBOSNIA-HERZ.\tBRAZIL\tBULGARIA\tBurnei\tCambodia\tCAMEROON\tCanada\tChile\tChina \tColombia\tCOTE D'IVOIRE\tCUBA\tCYPRUS\tCZECH REPUBLIC\tDENMARK\tDOMINICAN REP.\tECUADOR\tEGYPT\tEL SALVADOR\tESTONIA\tETHIOPIA\tFAROE ISLANDS\tFINLAND\tFRANCE\tGEORGIA\tGERMANY\tGREECE\tGREENLAND\tGUATEMALA\tHong Kong\tHUNGARY\tICELAND\tIndia\tIndonesia\tIRELAND\tISRAEL\tITALY\tJORDAN\tKAZAKHSTAN\tKOSOVO\tKUWAIT\tKYRGYZSTAN\tLATVIA\tLEBANON\tLIBYA\tLIECHTENSTEIN\tLITHUANIA\tLUXEMBOURG\tMACEDONIA\tMalaysia\tMALTA\tMAURITIUS\tMexico\tMONGOLIA\tMONTENEGRO\tMOROCCO\tMyanmar\tNepal\tNETHERLANDS\tNew Zealand\tNORWAY\tOMAN\tPakistan\tPALESTINE\tPANAMA\tPARAGUAY\tPERU\tPhilippines\tPOLAND\tPORTUGAL\tQATAR\tROMANIA\tRUSSIAN FED.\tSAUDI ARABIA\tSENEGAL\tSingapore\tSLOVAKIA\tSLOVENIA\tSOUTH AFRICA\tSouth Korea\tSPAIN\tSrilanka\tSUDAN\tSWEDEN\tSWITZERLAND\tTaiwan\tThailand\tTRINIDAD\tTUNISIA\tTURKEY\tUKRAINE\tUnited Arab Emirates\tUNITED KINGDOM\tUZBEKISTAN\tVENEZUELA\tVietnam\tVIRGIN ISLAND\tYEMEN\tZAMBIA", "openfda": { "k_number": [ "K770507", "K772240", "K812464", "K920601", "K791379", "K770211", "K792526", "K810808", "K863878", "K790100", "K863582", "K853400", "K791219", "K771262", "K840701", "K901535", "K772238", "K770657", "K840748", "K833428", "K850384", "K873202", "K781377", "K820774", "K993434", 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"P990001", "P960004", "P060027" ], "registration_number": [ "3004209178", "3012552532", "3008494315", "3013288201", "2032521", "3018094310", "3005334138", "2135338", "1028232", "3008483389", "3003120897", "3008973940", "2133641", "2648729", "9610139", "1000165971", "2124215", "9614453", "2649622", "2024024", "3006705815", "3033257494", "2017865", "3009380063", "3008159616", "2182208", "3002806603", "3004593495" ], "fei_number": [ "3012552532", "3004369318", "3005700659", "3013288201", "3018094310", "3002806500", "3005334138", "3003574398", "1028232", "3000203466", "3008483389", "3003120897", "3008973940", "2648729", "1000165971", "3002807576", "3008377825", "2124215", "2649622", "2024024", "3006705815", "3033257494", "2017865", "3009380063", "3008159616", "2182208", "3002806603", "3004593495" ], "device_name": "Implantable Pacemaker Pulse-Generator", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.3610", "device_class": "3" } } ] }