--- title: "ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defi... — FDA record Z-1727-2023 | 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-1727-2023-icd-crome-dr-mri-is1-df1-model-number-ddpc3d1-implantable-cardioverter-defibrillators/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defibrillators — FDA record Z-1727-2023 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 CROME DR MRI IS1 DF1, Model Number DDPC3D1; 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**: 487 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1727-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1727-2023%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 00763000178413, Lot Serial Numbers: RSP600249S, RSP600057S, RSP600253S, RSP600085S, RSP600014S, RSP600150S, RSP600148S, RSP600089S, RSP600091S, RSP600114S, RSP600189S, RSP600210S, RSP600394S, RSP600130S, RSP600216S, RSP600256S, RSP600386S, RSP600149S, RSP600245S, RSP600066S, RSP600068S, RSP600069S, RSP600083S, RSP600112S, RSP600132S, RSP600136S, RSP600404S, RSP600076S, RSP600731S, RSP600954S, RSP600955S, RSP600953S, RSP600070S, RSP600145S, RSP600157S, RSP600200S, RSP600226S, RSP600082S, RSP600139S, RSP600141S, RSP600152S, RSP600163S, RSP600074S, RSP600732S, RSP600204S, RSP600369S, RSP600726S, RSP600748S, RSP600048S, RSP600080S, RSP600363S, RSP600396S, RSP600397S, RSP600408S, RSP600444S, RSP600544S, RSP600335S, RSP600383S, RSP600400S, RSP600808S, RSP600862S, RSP600939S, RSP600949S, RSP600950S, RSP600218S, RSP600288S, RSP600246S, RSP600193S, RSP600395S, RSP600725S, RSP600360S, RSP600413S, RSP600202S, RSP600736S, RSP600138S, RSP600049S, RSP600065S, RSP600095S, RSP600346S, RSP600372S, RSP600059S, RSP600219S, RSP600079S, RSP600190S, RSP600398S, RSP600217S, RSP600230S, RSP600723S, RSP600203S, RSP600221S, RSP600187S, RSP600250S, RSP600276S, RSP600060S, RSP600267S, RSP600392S, RSP600813S, RSP600154S, RSP600209S, RSP600211S, RSP600224S, RSP600729S, RSP600758S, RSP600134S, RSP600096S, RSP600734S, RSP600273S, RSP600722S, RSP600945S, RSP600946S; GTIN 00763000178420, Lot Serial Numbers: RSP600738S, RSP601022S, RSP600759S, RSP600761S, RSP600976S, RSP600984S, RSP601035S, RSP601038S, RSP600783S, RSP600912S, RSP600930S, RSP601015S, RSP601085S, RSP601112S, RSP601105S, RSP600988S, RSP600871S, RSP601089S, RSP600824S, RSP600100S, RSP600155S, RSP600517S, RSP600627S, RSP600845S, RSP600523S, RSP600639S, RSP600861S, RSP600654S, RSP600575S, RSP600521S, RSP600609S, RSP600614S, RSP600640S, RSP600650S, RSP600742S, RSP600616S, RSP600513S, RSP600151S, RSP600641S, RSP600649S, RSP600850S, RSP600860S, RSP600651S, RSP600520S, RSP600618S, RSP600837S, RSP600794S, RSP600179S, RSP600594S, RSP600741S, RSP600524S, RSP600648S, RSP600143S, RSP600753S, RSP600056S, RSP600061S, RSP600064S, RSP600171S, RSP600172S, RSP600543S, RSP600554S, RSP600587S, RSP600633S, RSP600634S, RSP600652S, RSP600766S, RSP600789S, RSP600799S, RSP600811S, RSP600823S, RSP600836S, RSP600839S, RSP600841S, RSP600859S, RSP601013S, RSP601016S, RSP601064S, RSP601076S, RSP601093S, RSP601094S, RSP600876S, RSP600882S, RSP600653S, RSP600516S, RSP600877S, RSP600878S, RSP601101S, RSP601102S, RSP600842S, RSP600602S, RSP600727S, RSP600615S, RSP600561S, RSP600579S, RSP600027S, RSP600563S, RSP600591S, RSP600855S, RSP600041S, RSP600872S, RSP600034S, RSP600536S, RSP600595S, RSP600596S, RSP600538S, RSP600559S, RSP600724S, RSP600564S, RSP600508S, RSP600510S, RSP600511S, RSP600519S, RSP600522S, RSP600525S, RSP600526S, RSP600552S, RSP600662S, RSP600752S, RSP600760S, RSP600795S, RSP600816S, RSP600924S, RSP600515S, RSP600528S, RSP600747S, RSP600785S, RSP600786S, RSP600788S, RSP600790S, RSP600642S, RSP600643S, RSP600644S, RSP600693S, RSP600776S, RSP600621S, RSP600622S, RSP600623S, RSP600624S, RSP600625S, RSP600657S, RSP600695S, RSP600704S, RSP600744S, RSP600784S, RSP600797S, RSP600818S, RSP600819S, RSP600910S, RSP600547S, RSP600553S, RSP600555S, RSP600556S, RSP600557S, RSP600588S, RSP600592S, RSP600626S, RSP600655S, RSP600676S, RSP600685S, RSP600687S, RSP600688S, RSP600746S, RSP600822S, RSP600826S, RSP600827S, RSP600931S, RSP600414S, RSP600755S, RSP600542S, RSP600645S, RSP600659S, RSP600664S, RSP600665S, RSP600666S, RSP600667S, RSP600668S, RSP600669S, RSP600678S, RSP600698S, RSP600702S, RSP600769S, RSP600778S, RSP600779S, RSP600820S, RSP600829S, RSP600832S, RSP600880S, RSP600881S, RSP600888S, RSP600914S, RSP600915S, RSP600918S, RSP600934S, RSP600967S, RSP600968S, RSP601004S, RSP601005S, RSP601010S, RSP601017S, RSP601027S, RSP601029S, RSP600919S, RSP600975S, RSP600983S, RSP601058S, RSP600838S, RSP600165S, RSP600401S, RSP600590S, RSP600777S, RSP601100S, RSP600927S, RSP600593S, RSP600077S, RSP600767S, RSP600774S, RSP600909S, RSP600887S, RSP600537S, RSP600540S, RSP600125S, RSP600617S, RSP600852S, RSP600512S, RSP600531S, RSP600549S, RSP600574S, RSP600546S, RSP600606S, RSP600607S, RSP600610S, RSP600612S, RSP600613S, RSP600656S, RSP600658S, RSP600660S, RSP600663S, RSP600671S, RSP600672S, RSP600673S, RSP600674S, RSP600675S, RSP600679S, RSP600680S, RSP600681S, RSP600682S, RSP600683S, RSP600686S, RSP600696S, RSP600697S, RSP600699S, RSP600701S, RSP600771S, RSP600772S, RSP600791S, RSP600803S, RSP600804S, RSP600805S, RSP600806S, RSP600809S, RSP600810S, RSP600812S, RSP600825S, RSP600830S, RSP600886S, RSP600890S, RSP600906S, RSP601025S, RSP601059S, RSP600605S, RSP600597S, RSP600598S, RSP600599S, RSP600600S, RSP600601S, RSP600603S, RSP600604S, RSP600620S, RSP600661S, RSP600677S, RSP600690S, RSP600692S, RSP600703S, RSP600754S, RSP600802S, RSP600821S, RSP600884S, RSP600889S, RSP600897S, RSP600898S, RSP600913S, RSP600935S, RSP600985S, RSP600864S, RSP600865S, RSP600866S, RSP600560S, RSP600843S, RSP600670S, RSP600807S, RSP600920S, RSP600735S, RSP600743S, RSP600750S, RSP600757S, RSP600765S, RSP600775S, RSP600782S, RSP600793S, RSP600831S, RSP600833S, RSP600834S, RSP600846S, RSP600851S, RSP600856S, RSP600863S, RSP600867S, RSP600868S, RSP600879S, RSP600883S, RSP600885S, RSP600891S, RSP600892S, RSP600893S, RSP600894S, RSP600895S, RSP600896S, RSP600899S, RSP600900S, RSP600901S, RSP600907S, RSP600916S, RSP600917S, RSP600921S, RSP600923S, RSP600925S, RSP600926S, RSP600928S, RSP600929S, RSP600974S, RSP600977S, RSP600978S, RSP600981S, RSP600982S, RSP600986S, RSP600989S, RSP600990S, RSP600991S, RSP601002S, RSP601003S, RSP601011S, RSP601012S, RSP601014S, RSP601020S, RSP601023S, RSP601024S, RSP601028S, RSP601030S, RSP601034S, RSP601037S, RSP601040S, RSP601045S, RSP601046S, RSP601047S, RSP601056S, RSP601067S, RSP601069S, RSP601086S, RSP601098S, RSP601104S, RSP601106S, RSP601107S, RSP600684S, RSP601113S, RSP601114S, RSP600980S, RSP601096S | 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-1727-2023%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/)