--- title: "CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; Implantable Cardiovert... — FDA record Z-1758-2023 | 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-1758-2023-crtd-dtma2d4-claria-mri-ous-df4-model-number-dtma2d4-implantable-cardioverter-defibrillators/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; Implantable Cardioverter Defibrillators — FDA record Z-1758-2023 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**: CRTD DTMA2D4 CLARIA MRI OUS DF4, Model Number DTMA2D4; 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**: 4593 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1758-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1758-2023%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 00643169720664, Lot Serial Numbers: RPD605666S, RPD602978S, RPD602979S, RPD603034S, RPD604592S, RPD601674S, RPD603271S, RPD604163S, RPD605225S, RPD604970S, RPD601851S, RPD602346S, RPD602637S, RPD603019S, RPD605081S, RPD605207S, RPD604558S, RPD604927S, RPD604980S, RPD601671S, RPD601672S, RPD601677S, RPD601678S, RPD602218S, RPD602277S, RPD602303S, RPD602369S, RPD602439S, RPD602443S, RPD602581S, RPD602724S, RPD602728S, RPD602781S, RPD602793S, RPD602910S, RPD602940S, RPD603033S, RPD603173S, RPD603180S, RPD603254S, RPD603677S, RPD603733S, RPD603756S, RPD603966S, RPD603967S, RPD604091S, RPD604124S, RPD604201S, RPD604897S, RPD605386S, RPD605444S, RPD605446S, RPD605524S, RPD605667S, RPD605679S, RPD605428S, RPD604405S, RPD604954S, RPD604941S, RPD605596S, RPD601962S, RPD602692S, RPD602918S, RPD602973S, RPD602982S, RPD605595S, RPD605601S, RPD603067S, RPD602895S, RPD604445S, RPD602694S, RPD604443S, RPD604552S, RPD605084S, RPD603878S, RPD602612S, RPD602015S, RPD602203S, RPD602244S, RPD602348S, RPD602512S, RPD602649S, RPD602813S, RPD602835S, RPD602924S, RPD603046S, RPD603061S, RPD603062S, RPD603483S, RPD603567S, RPD603785S, RPD603849S, RPD603850S, RPD603860S, RPD603870S, RPD603888S, RPD604408S, RPD604562S, RPD604598S, RPD604616S, RPD604823S, RPD604923S, RPD605011S, RPD605053S, RPD605395S, RPD605403S, RPD605624S, RPD605673S, RPD601592S, RPD603971S, RPD604019S, RPD604497S, RPD604806S, RPD604924S, RPD605172S, RPD605252S, RPD605645S, RPD603584S, RPD605643S, RPD602423S, RPD604221S, RPD601924S, RPD602113S, RPD602179S, RPD602635S, RPD602963S, RPD603087S, RPD603108S, RPD603310S, RPD604038S, RPD604062S, RPD604349S, RPD604412S, RPD604563S, RPD604795S, RPD604990S, RPD605006S, RPD605122S, RPD605124S, RPD605140S, RPD605267S, RPD605337S, RPD605588S, RPD605674S, RPD601625S, RPD602073S, RPD604042S, RPD604347S, RPD604727S, RPD602999S, RPD604462S, RPD605042S, RPD602526S, RPD604432S, RPD602723S, RPD603149S, RPD603672S, RPD605231S, RPD601933S, RPD602094S, RPD602872S, RPD603885S, RPD604355S, RPD605208S, RPD605286S, RPD603649S, RPD603719S, RPD603729S, RPD603758S, RPD604197S, RPD602590S, RPD603135S, RPD603268S, RPD603297S, RPD604365S, RPD604528S, RPD604556S, RPD604565S, RPD605108S, RPD605158S, RPD603980S, RPD604184S, RPD604270S, RPD604577S, RPD605480S, RPD605039S, RPD601471S, RPD603435S, RPD603900S, RPD603976S, RPD604361S, RPD604467S, RPD605247S, RPD605636S, RPD603985S, RPD605298S, RPD605495S, RPD605614S, RPD603740S, RPD603450S, RPD603598S, RPD603613S, RPD604148S, RPD604194S, RPD604302S, RPD604485S, RPD604517S, RPD604606S, RPD604626S, RPD604401S, RPD604464S, RPD604532S, RPD605178S, RPD605204S, RPD605471S, RPD605531S, RPD605533S, RPD603775S, RPD604305S, RPD604609S, RPD605034S, RPD602289S, RPD602968S, RPD603504S, RPD603550S, RPD603862S, RPD604407S, RPD605061S, RPD605062S, RPD605063S, RPD605184S, RPD605249S, RPD605522S, RPD602469S, RPD603038S, RPD603523S, RPD604359S, RPD604391S, RPD604984S, RPD603615S, RPD603722S, RPD604617S, RPD602566S, RPD602571S, RPD603654S, RPD603757S, RPD604193S, RPD602115S, RPD602169S, RPD602516S, RPD603327S, RPD604266S, RPD604634S, RPD604826S, RPD605515S, RPD602118S, RPD601903S, RPD603680S, RPD603869S, RPD604409S, RPD604862S, RPD605050S, RPD605101S, RPD605259S, RPD601638S, RPD603717S, RPD602047S, RPD602192S, RPD602240S, RPD602598S, RPD602646S, RPD602687S, RPD602747S, RPD602812S, RPD602946S, RPD603074S, RPD603910S, RPD603969S, RPD603992S, RPD602145S, RPD602705S, RPD603749S, RPD604151S, RPD604217S, RPD604350S, RPD605163S, RPD605195S, RPD605209S, RPD605246S, RPD605589S, RPD602018S, RPD602364S, RPD602446S, RPD602626S, RPD603024S, RPD603650S, RPD603829S, RPD603972S, RPD604252S, RPD604298S, RPD604484S, RPD604650S, RPD605176S, RPD605292S, RPD605490S, RPD605501S, RPD601868S, RPD601930S, RPD602120S, RPD602320S, RPD602358S, RPD602464S, RPD603103S, RPD603156S, RPD603166S, RPD603187S, RPD603605S, RPD603981S, RPD603990S, RPD604035S, RPD604045S, RPD604611S, RPD605030S, RPD605248S, RPD605482S, RPD605492S, RPD601778S, RPD602250S, RPD604268S, RPD604289S, RPD604476S, RPD603927S, RPD603072S, RPD603812S, RPD603952S, RPD604324S, RPD604685S, RPD605427S, RPD605468S, RPD605532S, RPD602397S, RPD603264S, RPD603510S, RPD603660S, RPD603747S, RPD602792S, RPD603815S, RPD602396S, RPD602436S, RPD602776S, RPD603028S, RPD603699S, RPD603769S, RPD604150S, RPD605334S, RPD602187S, RPD601474S, RPD602065S, RPD601603S, RPD601610S, RPD602124S, RPD602184S, RPD602915S, RPD603754S, RPD602037S, RPD602053S, RPD604050S, RPD602359S, RPD601608S, RPD601705S, RPD601754S, RPD602183S, RPD602313S, RPD602315S, RPD602409S, RPD602557S, RPD602775S, RPD602778S, RPD603582S, RPD603827S, RPD604089S, RPD604212S, RPD604274S, RPD604312S, RPD604470S, RPD604509S, RPD605200S, RPD605212S, RPD601612S, RPD601639S, RPD601686S, RPD601950S, RPD602076S, RPD602123S, RPD602797S, RPD603208S, RPD603610S, RPD603723S, RPD603755S, RPD604510S, RPD604654S, RPD604683S, RPD601618S, RPD604456S, RPD604995S, RPD605377S, RPD601478S, RPD601503S, RPD601598S, RPD602798S, RPD604637S, RPD604855S, RPD605049S, RPD605236S, RPD605455S, RPD601606S, RPD602375S, RPD602938S, RPD603143S, RPD604939S, RPD605283S, RPD605637S, RPD601600S, RPD604186S, RPD603489S, RPD603592S, RPD603617S, RPD603806S, RPD601553S, RPD601684S, RPD602783S, RPD602998S, RPD603499S, RPD604105S, RPD604204S, RPD604458S, RPD602371S, RPD601917S, RPD603714S, RPD601642S, RPD601643S, RPD601616S, RPD601798S, RPD605475S, RPD603300S, RPD604154S, RPD604725S, RPD605676S, RPD603296S, RPD602204S, RPD602207S, RPD601796S, RPD602374S, RPD603279S, RPD603452S, RPD603500S, RPD603562S, RPD603702S, RPD604211S, RPD604265S, RPD604303S, RPD604313S, RPD604785S, RPD604979S, RPD605307S, RPD605362S, RPD605627S, RPD602606S, RPD603877S, RPD602485S, RPD604292S, RPD605133S, RPD605299S, RPD605390S, RPD602210S, RPD601477S, RPD601755S, RPD601952S, RPD605275S, RPD602200S, RPD602202S, RPD602208S, RPD601499S, RPD601685S, RPD602064S, RPD602133S, RPD602519S, RPD603530S, RPD604189S, RPD604196S, RPD604207S, RPD604219S, RPD604687S, RPD604819S, RPD605187S, RPD605234S, RPD605251S, RPD605341S, RPD605372S, RPD605474S, RPD605638S, RPD605659S, RPD602231S, RPD603874S, RPD603975S, RPD604435S, RPD605573S, RPD601607S, RPD602532S, RPD604001S, RPD604531S, RPD605215S, RPD602558S, RPD603940S, RPD603941S, RPD603943S, RPD601954S, RPD602111S, RPD602952S, RPD603202S, RPD603893S, RPD601759S, RPD601972S, RPD602082S, RPD604267S, RPD602140S, RPD602225S, RPD601835S, RPD601843S, RPD601899S, RPD601986S, RPD601987S, RPD602071S, RPD602430S, RPD603236S, RPD603653S, RPD604253S, RPD604337S, RPD605013S, RPD605510S, RPD605609S, RPD605422S, RPD605548S, RPD605591S, RPD602339S, RPD604000S, RPD605302S, RPD605477S, RPD602642S, RPD603614S, RPD604224S, RPD604520S, RPD603589S, RPD605146S, RPD603022S, RPD604832S, RPD604877S, RPD605094S, RPD605670S, RPD605649S, RPD603081S, RPD603289S, RPD605131S, RPD605205S, RPD605605S, RPD603021S, RPD603112S, RPD604455S, RPD604742S, RPD604817S, RPD605544S, RPD601824S, RPD602475S, RPD603673S, RPD603655S, RPD604320S, RPD601998S, RPD602007S, RPD602543S, RPD602710S, RPD602749S, RPD602753S, RPD602995S, RPD603070S, RPD603228S, RPD603318S, RPD603549S, RPD603661S, RPD603902S, RPD604123S, RPD604220S, RPD604474S, RPD604597S, RPD604781S, RPD603897S, RPD603983S, RPD604160S, RPD605496S, RPD605576S, RPD602639S, RPD604066S, RPD604542S, RPD602641S, RPD603153S, RPD605107S, RPD601655S, RPD601825S, RPD601827S, RPD601855S, RPD602146S, RPD602174S, RPD602333S, RPD602843S, RPD602845S, RPD604065S, RPD605279S, RPD605285S, RPD605546S, RPD602366S, RPD602426S, RPD602427S, RPD602734S, RPD602790S, RPD602819S, RPD602931S, RPD603088S, RPD603834S, RPD603842S, RPD602628S, RPD602664S, RPD603521S, RPD603690S, RPD603851S, RPD604861S, RPD601734S, RPD601828S, RPD601859S, RPD601860S, RPD603181S, RPD603278S, RPD605206S, RPD601536S, RPD602961S, RPD602994S, RPD602818S, RPD604064S, RPD604280S, RPD604442S, RPD604461S, RPD604780S, RPD604815S, RPD605075S, RPD605303S, RPD605304S, RPD605542S, RPD605497S, RPD602002S, RPD602253S, RPD602951S, RPD602981S, RPD603090S, RPD603950S, RPD605652S, RPD605083S, RPD605593S, RPD601791S, RPD601981S, RPD603899S, RPD604417S, RPD605005S, RPD605309S, RPD601715S, RPD602148S, RPD602338S, RPD604643S, RPD605628S, RPD605633S, RPD602196S, RPD602334S, RPD602561S, RPD602811S, RPD604063S, RPD604255S, RPD601640S, RPD605106S, RPD605141S, RPD602980S, RPD604315S, RPD603788S, RPD602052S, RPD602083S, RPD602084S, RPD602841S, RPD602922S, RPD603146S, RPD603443S, RPD603444S, RPD604638S, RPD604739S, RPD604740S, RPD601254S, RPD601511S, RPD601912S, RPD602323S, RPD603267S, RPD603627S, RPD603642S, RPD603796S, RPD605610S, RPD601469S, RPD601864S, RPD601988S, RPD602652S, RPD602972S, RPD603831S, RPD603852S, RPD604041S, RPD604127S, RPD605026S, RPD605103S, RPD605626S, RPD605640S, RPD602848S, RPD603837S, RPD604282S, RPD603177S, RPD604390S, RPD601708S, RPD602957S, RPD603069S, RPD603397S, RPD603441S, RPD603602S, RPD603603S, RPD603608S, RPD604336S, RPD604400S, RPD604788S, RPD604813S, RPD602449S, RPD603114S, RPD601532S, RPD601571S, RPD601661S, RPD602009S, RPD602170S, RPD603344S, RPD603345S, RPD604814S, RPD601832S, RPD602324S, RPD602954S, RPD602955S, RPD601955S, RPD602638S, RPD605668S, RPD601829S, RPD602172S, RPD601852S, RPD602028S, RPD602242S, RPD602291S, RPD602379S, RPD602444S, RPD603082S, RPD603234S, RPD603502S, RPD603743S, RPD604181S, RPD604291S, RPD604341S, RPD604397S, RPD604686S, RPD604765S, RPD605143S, RPD605467S, RPD605528S, RPD601865S, RPD602155S, RPD602156S, RPD602163S, RPD602331S, RPD602854S, RPD602867S, RPD604300S, RPD604667S, RPD604717S, RPD605662S, RPD602305S, RPD603216S, RPD603448S, RPD603449S, RPD603451S, RPD603453S, RPD603462S, RPD604049S, RPD604459S, RPD604475S, RPD604503S, RPD604561S, RPD604594S, RPD604645S, RPD604682S, RPD604732S, RPD604851S, RPD605192S, RPD605244S, RPD605502S, RPD605584S, RPD605631S, RPD602697S, RPD602822S, RPD604656S, RPD604782S, RPD605223S, RPD605347S, RPD605481S, RPD605574S, RPD605360S, RPD601786S, RPD601949S, RPD602034S, RPD602161S, RPD602402S, RPD602500S, RPD603376S, RPD603474S, RPD603830S, RPD603889S, RPD603924S, RPD604052S, RPD605007S, RPD602209S, RPD605213S, RPD601491S, RPD601569S, RPD601736S, RPD601990S, RPD602171S, RPD602173S, RPD602844S, RPD601487S, RPD602592S, RPD603492S, RPD604843S, RPD605393S, RPD605648S, RPD601465S, RPD601502S, RPD603121S, RPD603125S, RPD603663S, RPD603664S, RPD605296S, RPD604879S, RPD602177S, RPD602831S, RPD603063S, RPD604967S, RPD605201S, RPD605366S, RPD604074S, RPD603999S, RPD601943S, RPD602185S, RPD602478S, RPD602699S, RPD602751S, RPD602864S, RPD603974S, RPD604128S, RPD605306S, RPD605367S, RPD601878S, RPD602384S, RPD602576S, RPD602611S, RPD603335S, RPD604460S, RPD604850S, RPD605211S, RPD605289S, RPD605644S, RPD602540S, RPD602644S, RPD602743S, RPD605029S, RPD602414S, RPD603505S, RPD604719S, RPD604722S, RPD604891S, RPD605041S, RPD605287S, RPD603179S, RPD603390S, RPD603421S, RPD603595S, RPD603669S, RPD604079S, RPD604082S, RPD604226S, RPD604242S, RPD604244S, RPD604583S, RPD604816S, RPD604909S, RPD604910S, RPD604921S, RPD605370S, RPD605408S, RPD601897S, RPD602932S, RPD602936S, RPD605268S, RPD605269S, RPD605326S, RPD605517S, RPD605654S, RPD605291S, RPD604540S, RPD605647S, RPD603391S, RPD603456S, RPD605077S, RPD603576S, RPD603577S, RPD603578S, RPD604017S, RPD601876S, RPD602021S, RPD602181S, RPD602666S, RPD602740S, RPD602828S, RPD605635S, RPD605093S, RPD603544S, RPD601523S, RPD601682S, RPD601738S, RPD602035S, RPD602085S, RPD602144S, RPD602245S, RPD602340S, RPD602341S, RPD602380S, RPD602506S, RPD602509S, RPD602912S, RPD602987S, RPD602989S, RPD603048S, RPD603367S, RPD603369S, RPD603853S, RPD603854S, RPD604342S, RPD604343S, RPD604631S, RPD604774S, RPD604779S, RPD601995S, RPD605549S, RPD601766S, RPD601773S, RPD602919S, RPD603838S, RPD601548S, RPD603394S, RPD601940S, RPD602107S, RPD602584S, RPD602585S, RPD603346S, RPD603347S, RPD603383S, RPD603384S, RPD603426S, RPD604628S, RPD601964S, RPD602038S, RPD602226S, RPD602352S, RPD603190S, RPD603248S, RPD601963S, RPD604824S, RPD604543S, RPD601466S, RPD601578S, RPD602091S, RPD602599S, RPD602643S, RPD602674S, RPD6... | 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-1758-2023%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-1758-2023%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/)