--- title: "ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardiove... — FDA record Z-1802-2023 | Is It on Recall" description: "There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs)" url: https://isitonrecall.com/recall/fda-device-z-1802-2023-icd-vr-dvex3e4-ev-icd-ev4-pivotal-model-number-dvex3e4-implantable-cardioverter-defibrillators/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators — FDA record Z-1802-2023 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date May 10, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL, Model Number DVEX3E4; Implantable Cardioverter Defibrillators - **Reason**: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds. - **Classification**: Class I - **Recalling firm**: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) - **Quantity**: 289 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1802-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1802-2023%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | GTIN 00763000217891, Lot Serial Numbers: EVS600719S, EVS600271S, EVS600272S, EVS600273S, EVS600274S, EVS600322S, EVS600324S, EVS600325S, EVS600326S, EVS600366S, EVS600372S, EVS600503S, EVS600504S, EVS600529S, EVS600530S, EVS600531S, EVS600547S, EVS600548S, EVS600623S, EVS600558S, EVS600559S, EVS600560S, EVS600320S, EVS600549S, EVS600550S, EVS600551S, EVS600619S, EVS600620S, EVS600633S, EVS600635S, EVS600264S, EVS600338S, EVS600339S, EVS600546S, EVS600579S, EVS600337S, EVS600578S, EVS600580S, EVS600303S, EVS600304S, EVS600305S, EVS600306S, EVS600307S, EVS600308S, EVS600319S, EVS600332S, EVS600333S, EVS600335S, EVS600340S, EVS600373S, EVS600375S, EVS600376S, EVS600377S, EVS600378S, EVS600381S, EVS600485S, EVS600486S, EVS600496S, EVS600498S, EVS600532S, EVS600541S, EVS600542S, EVS600576S, EVS600577S, EVS600616S, EVS600617S, EVS600618S, EVS600275S, EVS600277S, EVS600279S, EVS600246S, EVS600247S, EVS600248S, EVS600251S, EVS600327S, EVS600328S, EVS600095S, EVS600096S, EVS600097S, EVS600098S, EVS600252S, EVS600255S, EVS600554S, EVS600555S, EVS600561S, EVS600566S, EVS600629S, EVS600258S, EVS600259S, EVS600260S, EVS600086S, EVS600094S, EVS600256S, EVS600263S, EVS600556S, EVS600557S, EVS600085S, EVS600262S, EVS600495S, EVS600568S, EVS600534S, EVS600285S, EVS600288S, EVS600569S, EVS600570S, EVS600638S, EVS600639S, EVS600640S, EVS600393S, EVS600418S, EVS600385S, EVS600015S, EVS600016S, EVS600027S, EVS600517S, EVS600011S, EVS600012S, EVS600013S, EVS600420S, EVS600421S, EVS600014S, EVS600028S, EVS600068S, EVS600069S, EVS600070S, EVS600071S, EVS600072S, EVS600074S, EVS600078S, EVS600505S, EVS600518S, EVS600520S, EVS600720S; GTIN 00763000217907, Lot Serial Numbers: EVS600396S, EVS600061S, EVS600218S, EVS600204S, EVS600407S, EVS600646S, EVS600645S, EVS600647S, EVS600648S, EVS600179S, EVS600397S, EVS600040S, EVS600044S, EVS600048S, EVS600049S, EVS600139S, EVS600140S, EVS600232S, EVS600039S, EVS600056S, EVS600150S, EVS600231S, EVS600344S, EVS600141S, EVS600165S, EVS600166S, EVS600368S, EVS600351S, EVS600353S, EVS600354S, EVS600389S, EVS600390S, EVS600032S, EVS600033S, EVS600034S, EVS600045S, EVS600076S, EVS600055S, EVS600178S, EVS600155S, EVS600134S, EVS600209S, EVS600210S, EVS600205S, EVS600357S, EVS600653S, EVS600654S, EVS600050S, EVS600149S, EVS600161S, EVS600162S, EVS600164S, EVS600212S, EVS600664S, EVS600657S, EVS600658S, EVS600051S, EVS600053S, EVS600135S, EVS600211S, EVS600234S, EVS600236S, EVS600343S, EVS600348S, EVS600349S, EVS600350S, EVS600411S, EVS600412S, EVS600659S, EVS600254S, EVS600031S, EVS600159S, EVS600415S, EVS600206S, EVS600655S, EVS600656S, EVS600035S, EVS600060S, EVS600063S, EVS600157S, EVS600180S, EVS600364S, EVS600365S, EVS600643S, EVS600671S, EVS600052S, EVS600169S, EVS600170S, EVS600177S, EVS600199S, EVS600201S, EVS600202S, EVS600203S, EVS600207S, EVS600208S, EVS600220S, EVS600221S, EVS600367S, EVS600369S, EVS600371S, EVS600374S, EVS600380S, EVS600382S, EVS600384S, EVS600399S, EVS600400S, EVS600403S, EVS600423S, EVS600642S, EVS600644S, EVS600668S, EVS600669S, EVS600670S, EVS600672S, EVS600058S, EVS600057S, EVS600167S, EVS600168S, EVS600214S, EVS600153S, EVS600154S, EVS600156S, EVS600182S, EVS600408S, EVS600370S, EVS600662S, EVS600075S, EVS600649S, EVS600650S, EVS600652S, EVS600663S, EVS600651S, EVS600064S, EVS600065S, EVS600073S, EVS600142S, EVS600216S, EVS600239S, EVS600136S, EVS600137S, EVS600138S, EVS600143S, EVS600144S, EVS600145S, EVS600146S, EVS600147S, EVS600148S, EVS600158S, EVS600171S, EVS600172S, EVS600175S, EVS600036S, EVS600037S, EVS600038S, EVS600054S, EVS600641S | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution US Nationwide - Worldwide Distribution States below are derived from the distribution text, including nationwide wording. 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These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1802-2023%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) records](https://isitonrecall.com/brand/medtronic-inc-cardiac-rhythm-and-heart-failure-crhf/)