--- title: "ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable C... — FDA record Z-1716-2023 | 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-1716-2023-icd-dr-ddmc3d4-evera-mri-s-is-1-df4-glob-model-number-ddmc3d4-implantable-cardioverter-defibrillator/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators — FDA record Z-1716-2023 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-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; 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**: 37,547 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1716-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1716-2023%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 00643169720527, Lot Serial Numbers: PHZ203294H, PHZ204099H, PHZ202880H, PHZ202731H, PHZ203576H, PHZ203873H, PHZ202558H, PHZ202949H, PHZ203163H, PHZ204430H, PHZ203645H, PHZ204171H, PHZ204583H, PHZ204585H, PHZ204589H, PHZ204600H, PHZ204629H, PHZ204676H, PHZ204879H, PHZ204932H, PHZ204991H, PHZ205067H, PHZ205076H, PHZ205168H, PHZ205219H, PHZ205254H, PHZ205303H, PHZ204750H, PHZ202687H, PHZ203913H, PHZ203379H, PHZ203419H, PHZ203421H, PHZ203422H, PHZ203423H, PHZ203425H, PHZ203426H, PHZ203427H, PHZ203435H, PHZ203798H, PHZ203805H, PHZ203808H, PHZ203809H, PHZ203811H, PHZ203816H, PHZ203819H, PHZ203820H, PHZ203822H, PHZ203828H, PHZ203829H, PHZ203830H, PHZ203831H, PHZ204440H, PHZ204442H, PHZ204444H, PHZ204445H, PHZ204446H, PHZ204447H, PHZ204448H, PHZ204449H, PHZ204451H, PHZ205205H, PHZ205206H, 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PHZ205328H, PHZ205392H, PHZ205443H, PHZ202535H, PHZ202643H, PHZ202653H, PHZ202744H, PHZ202762H, PHZ202881H, PHZ202934H, PHZ203039H, PHZ203059H, PHZ203103H, PHZ203261H, PHZ203370H, PHZ203535H, PHZ203567H, PHZ203625H, PHZ203840H, PHZ203842H, PHZ203878H, PHZ204058H, PHZ204281H, PHZ204323H, PHZ204520H, PHZ204635H, PHZ204670H, PHZ204812H, PHZ204838H, PHZ204851H, PHZ204908H, PHZ205015H, PHZ205028H, PHZ205185H, PHZ205453H, PHZ203644H, PHZ204356H, PHZ204379H, PHZ203922H, PHZ203969H, PHZ204091H, PHZ204098H, PHZ204100H, PHZ204164H, PHZ204317H, PHZ204654H, PHZ204661H, PHZ204761H, PHZ202553H, PHZ202746H, PHZ202787H, PHZ203174H, PHZ203510H, PHZ203526H, PHZ203568H, PHZ203674H, PHZ203690H, PHZ204226H, PHZ204306H, PHZ204522H, PHZ204549H, PHZ204914H, PHZ204918H, PHZ205031H, PHZ205147H, PHZ203415H, PHZ202623H, PHZ202800H, PHZ202928H, PHZ203189H, PHZ203240H, PHZ203331H, PHZ203547H, PHZ203558H, PHZ204071H, PHZ204131H, PHZ204773H, PHZ205010H, PHZ205374H, PHZ202659H, PHZ202888H, PHZ202897H, PHZ202906H, 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PHZ202802H, PHZ202989H, PHZ203115H, PHZ203150H, PHZ203207H, PHZ203348H, PHZ203375H, PHZ203414H, PHZ203452H, PHZ203565H, PHZ203664H, PHZ203738H, PHZ203740H, PHZ203741H, PHZ203743H, PHZ203744H, PHZ205121H, PHZ204648H, PHZ204883H, PHZ204897H, PHZ204916H, PHZ202705H, PHZ202755H, PHZ202935H, PHZ203242H, PHZ204961H, PHZ204922H, PHZ204923H, PHZ205181H, PHZ203468H, PHZ203579H, PHZ203614H, PHZ203679H, PHZ204478H, PHZ204382H, PHZ204880H, PHZ205183H, PHZ203654H, PHZ203748H, PHZ203585H, PHZ203593H, PHZ202564H, PHZ202662H, PHZ202663H, PHZ202667H, PHZ202712H, PHZ202742H, PHZ202752H, PHZ202759H, PHZ202765H, PHZ202771H, PHZ202785H, PHZ202810H, PHZ202815H, PHZ202958H, PHZ202964H, PHZ203004H, PHZ203013H, PHZ203017H, PHZ203045H, PHZ203116H, PHZ203129H, PHZ203139H, PHZ203183H, PHZ203206H, PHZ203211H, PHZ203236H, PHZ203246H, PHZ203443H, PHZ203454H, PHZ203481H, PHZ203485H, PHZ203515H, PHZ203592H, PHZ203622H, PHZ203647H, PHZ203773H, PHZ203794H, PHZ203821H, PHZ203824H, PHZ203826H, PHZ203860H, PHZ203915H, PHZ203919H, PHZ203964H, PHZ204038H, PHZ204148H, PHZ204165H, PHZ204169H, PHZ204180H, PHZ204264H, PHZ204302H, PHZ204324H, PHZ204357H, PHZ204397H, PHZ204403H, PHZ204412H, PHZ204557H, PHZ204647H, PHZ204655H, PHZ204712H, PHZ204764H, PHZ204775H, PHZ2... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1716-2023%22). 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. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Jun 28, 2023 - **Recall initiation date**: May 10, 2023 - **Center classification date**: Jun 16, 2023 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. 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-1716-2023%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/)