Recall archive / FDA device enforcement

ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; Implantable Cardioverter Defibrillators — FDA record Z-1804-2023

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. Source coverage and dates.

What the record says

Product: ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; 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: 34350 units
Agency-reported status: Ongoing
Source record identifier: Z-1804-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
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PKX236776H, PKX236779H, PKX236780H, PKX237303H, PKX237823H, PKX238856H, PKX2...

Label field

Details supplied by the agency

Lot, code or applicability

GTIN 00643169720794, Lot Serial Numbers: PKX219646H, PKX220040H, PKX220056H, PKX221681H, PKX222407H, PKX222934H, PKX223422H, PKX225541H, PKX228394H, PKX228784H, PKX228814H, PKX230405H, PKX231486H, PKX232877H, PKX233043H, PKX236253H, PKX238847H, PKX238969H, PKX224741H, PKX224742H, PKX226542H, PKX230306H, PKX231799H, PKX231802H, PKX234882H, PKX234889H, PKX236705H, PKX236715H, PKX239415H, PKX240693H, PKX234754H, PKX237931H, PKX221151H, PKX222802H, PKX224257H, PKX227009H, PKX227059H, PKX227453H, PKX229189H, PKX231976H, PKX232346H, PKX233404H, PKX235182H, PKX236627H, PKX240315H, PKX219199H, PKX221009H, PKX221252H, PKX221253H, PKX221256H, PKX221257H, PKX221262H, PKX221264H, PKX221271H, PKX221272H, PKX221273H, PKX221276H, PKX224585H, PKX224586H, PKX224589H, PKX224590H, PKX224592H, PKX224593H, PKX224594H, PKX224595H, PKX229231H, PKX229232H, PKX229234H, PKX229237H, PKX229239H, PKX229240H, PKX230943H, PKX230945H, PKX230956H, PKX230960H, PKX230961H, PKX230962H, PKX230965H, PKX230967H, PKX234196H, PKX234197H, PKX234214H, PKX234215H, PKX234216H, PKX234217H, PKX234220H, PKX234221H, PKX236947H, PKX237017H, PKX237021H, PKX237022H, PKX237023H, PKX237024H, PKX237037H, PKX237040H, PKX237043H, PKX237044H, PKX237045H, PKX237046H, PKX237048H, PKX237049H, PKX237051H, PKX237052H, PKX237054H, PKX237055H, PKX237056H, PKX239045H, PKX239046H, PKX239050H, PKX239053H, PKX239056H, PKX239057H, PKX239063H, PKX239064H, PKX239065H, PKX239066H, PKX239067H, PKX239068H, PKX239069H, PKX218877H, PKX221372H, PKX221452H, PKX221877H, PKX222446H, PKX224263H, PKX225312H, PKX225546H, PKX227161H, PKX228117H, PKX228815H, PKX228816H, PKX229323H, PKX230703H, PKX232371H, PKX233385H, PKX233534H, PKX234142H, PKX234885H, PKX235109H, PKX235523H, PKX235764H, PKX237365H, PKX237711H, PKX237771H, PKX239911H, PKX222254H, PKX225474H, PKX227405H, PKX230389H, PKX231519H, PKX231797H, PKX233081H, PKX233268H, PKX233842H, PKX235225H, PKX235355H, PKX238652H, PKX239523H, PKX239862H, PKX239109H, PKX239281H, PKX220770H, PKX220852H, PKX220991H, PKX221324H, PKX221329H, PKX221332H, PKX221367H, PKX221687H, PKX223042H, PKX223118H, PKX223138H, PKX224303H, PKX225070H, PKX225333H, PKX225446H, PKX225491H, PKX225519H, PKX225789H, PKX225800H, PKX226463H, PKX226588H, PKX227195H, PKX227895H, PKX229310H, PKX230606H, PKX231077H, PKX231080H, PKX231082H, PKX233426H, PKX235052H, PKX235053H, PKX235054H, PKX235056H, PKX235057H, PKX235058H, PKX235065H, PKX235066H, PKX235069H, PKX237488H, PKX237670H, PKX239890H, PKX240068H, PKX228358H, PKX219394H, PKX219395H, PKX222161H, PKX222163H, PKX222165H, PKX224861H, PKX224862H, PKX224864H, PKX224868H, PKX224871H, PKX231088H, PKX231093H, PKX234361H, PKX234362H, PKX234363H, PKX234366H, PKX237892H, PKX238540H, PKX238541H, PKX239130H, PKX232620H, PKX219461H, PKX220299H, PKX224934H, PKX237831H, PKX239614H, PKX240182H, PKX218955H, PKX219179H, PKX219514H, PKX219943H, PKX220302H, PKX220482H, PKX220584H, PKX220846H, PKX222838H, PKX223791H, PKX225167H, PKX225279H, PKX225280H, PKX226264H, PKX226925H, PKX227464H, PKX227898H, PKX228211H, PKX229778H, PKX230320H, PKX230432H, PKX230594H, PKX230618H, PKX230751H, PKX230894H, PKX230928H, PKX232987H, PKX233075H, PKX233184H, PKX233784H, PKX234498H, PKX234696H, PKX235131H, PKX235184H, PKX235812H, PKX236021H, PKX236540H, PKX236630H, PKX236823H, PKX237631H, PKX237636H, PKX237677H, PKX238342H, PKX238923H, PKX220324H, PKX220915H, PKX230111H, PKX218724H, PKX219674H, PKX219788H, PKX220190H, PKX220247H, PKX220410H, PKX220586H, PKX220800H, PKX220842H, PKX221177H, PKX221521H, PKX222932H, PKX223022H, PKX223088H, PKX223305H, PKX223721H, PKX223916H, PKX223964H, PKX224219H, PKX224747H, PKX224918H, PKX225364H, PKX225699H, PKX226090H, PKX226431H, PKX227173H, PKX230070H, PKX230240H, PKX230470H, PKX230496H, PKX230964H, PKX231090H, PKX231147H, PKX231224H, PKX232867H, PKX233324H, PKX239004H, PKX240415H, PKX221788H, PKX221801H, PKX221802H, PKX224379H, PKX226579H, PKX226580H, PKX229292H, PKX229560H, PKX229571H, PKX229577H, PKX233827H, PKX235529H, PKX239538H, PKX220298H, PKX220313H, PKX220443H, PKX222355H, PKX223184H, PKX223582H, PKX224085H, PKX225037H, PKX225673H, PKX227072H, PKX228139H, PKX228404H, PKX229863H, PKX229865H, PKX229867H, PKX230407H, PKX233691H, PKX234944H, PKX234948H, PKX234950H, PKX235907H, PKX235942H, PKX235957H, PKX236979H, PKX237688H, PKX237692H, PKX238134H, PKX238466H, PKX239152H, PKX239155H, PKX239238H, PKX239665H, PKX229061H, PKX219196H, PKX219202H, PKX225041H, PKX225048H, PKX225053H, PKX225055H, PKX225058H, PKX225061H, PKX229645H, PKX229646H, PKX229661H, PKX229668H, PKX229673H, PKX230054H, PKX234449H, PKX234450H, PKX234452H, PKX228388H, PKX230507H, PKX231118H, PKX233577H, PKX235885H, PKX237938H, PKX220052H, PKX220425H, PKX220872H, PKX222368H, PKX222879H, PKX228915H, PKX229453H, PKX229991H, PKX231447H, PKX232359H, PKX236437H, PKX237400H, PKX237886H, PKX238624H, PKX238895H, PKX222570H, PKX228473H, PKX229660H, PKX238205H, PKX236116H, PKX220509H, PKX227574H, PKX234191H, PKX235833H, PKX238321H, PKX220546H, PKX221369H, PKX224008H, PKX224129H, PKX224143H, PKX227468H, PKX229966H, PKX232828H, PKX233659H, PKX233751H, PKX235834H, PKX236303H, PKX238798H, PKX240218H, PKX218818H, PKX218939H, PKX219555H, PKX228008H, PKX228009H, PKX228019H, PKX228022H, PKX230476H, PKX230521H, PKX231865H, PKX232322H, PKX232666H, PKX233210H, PKX235215H, PKX236238H, PKX236248H, PKX236400H, PKX236402H, PKX236470H, PKX236511H, PKX237569H, PKX237654H, PKX237668H, PKX237669H, PKX238373H, PKX238498H, PKX239149H, PKX239473H, PKX239608H, PKX239662H, PKX239672H, PKX239889H, PKX239894H, PKX240192H, PKX240533H, PKX240810H, PKX218917H, PKX219254H, PKX219975H, PKX220161H, PKX220231H, PKX220756H, PKX222571H, PKX223290H, PKX225330H, PKX225558H, PKX225742H, PKX227659H, PKX228158H, PKX229523H, PKX229602H, PKX230120H, PKX231606H, PKX233628H, PKX233824H, PKX234131H, PKX234274H, PKX234308H, PKX234574H, PKX235708H, PKX236014H, PKX239837H, PKX219193H, PKX225586H, PKX229325H, PKX229326H, PKX229822H, PKX230911H, PKX231431H, PKX232029H, PKX234544H, PKX235079H, PKX235388H, PKX237424H, PKX238441H, PKX218784H, PKX219839H, PKX220047H, PKX220108H, PKX220112H, PKX220208H, PKX220403H, PKX220839H, PKX220923H, PKX221031H, PKX221160H, PKX221600H, PKX221601H, PKX222245H, PKX222685H, PKX222748H, PKX222984H, PKX223186H, PKX223195H, PKX223408H, PKX223725H, PKX224004H, PKX224070H, PKX224247H, PKX224309H, PKX224591H, PKX225052H, PKX225987H, PKX226024H, PKX226111H, PKX226447H, PKX226932H, PKX226991H, PKX227127H, PKX227680H, PKX227746H, PKX227784H, PKX227892H, PKX227963H, PKX228024H, PKX228194H, PKX228216H, PKX228370H, PKX228372H, PKX229043H, PKX230511H, PKX230512H, PKX230552H, PKX230572H, PKX230582H, PKX230704H, PKX231160H, PKX231182H, PKX231261H, PKX231295H, PKX232640H, PKX232778H, PKX233034H, PKX233076H, PKX233300H, PKX233346H, PKX233478H, PKX233481H, PKX233576H, PKX233926H, PKX235169H, PKX235243H, PKX235329H, PKX235370H, PKX235589H, PKX235597H, PKX235897H, PKX236003H, PKX236060H, PKX236203H, PKX236231H, PKX236432H, PKX236825H, PKX236830H, PKX237852H, PKX238056H, PKX238106H, PKX238485H, PKX238535H, PKX238924H, PKX239280H, PKX239492H, PKX239511H, PKX239563H, PKX239565H, PKX239584H, PKX239593H, PKX239678H, PKX240214H, PKX240482H, PKX240684H, PKX240698H, PKX240761H, PKX240804H, PKX221140H, PKX228329H, PKX229367H, PKX231866H, PKX231869H, PKX233612H, PKX238188H, PKX220620H, PKX221194H, PKX222753H, PKX222833H, PKX223048H, PKX224001H, PKX224114H, PKX226985H, PKX227697H, PKX229657H, PKX230182H, PKX232945H, PKX233080H, PKX233505H, PKX234382H, PKX240488H, PKX220053H, PKX222871H, PKX224893H, PKX227049H, PKX233707H, PKX235262H, PKX236595H, PKX239543H, PKX239607H, PKX240165H, PKX220197H, PKX223888H, PKX231148H, PKX234168H, PKX237108H, PKX239079H, PKX232311H, PKX233226H, PKX233336H, PKX233446H, PKX234955H, PKX236294H, PKX219276H, PKX224865H, PKX230358H, PKX224804H, PKX224805H, PKX224808H, PKX228920H, PKX228922H, PKX228923H, PKX228924H, PKX229374H, PKX231823H, PKX231826H, PKX231830H, PKX231831H, PKX231833H, PKX234708H, PKX234772H, PKX234774H, PKX238481H, PKX238842H, PKX239080H, PKX239855H, PKX240734H, PKX240736H, PKX218848H, PKX220517H, PKX221236H, PKX221750H, PKX222535H, PKX222874H, PKX223480H, PKX224089H, PKX225230H, PKX225363H, PKX225792H, PKX226298H, PKX226888H, PKX230870H, PKX231340H, PKX233928H, PKX234792H, PKX234821H, PKX234826H, PKX234839H, PKX235783H, PKX221279H, PKX224276H, PKX224278H, PKX226913H, PKX230774H, PKX233495H, PKX235520H, PKX235770H, PKX235785H, PKX236218H, PKX239897H, PKX239926H, PKX219308H, PKX219310H, PKX219311H, PKX221190H, PKX224545H, PKX224547H, PKX225980H, PKX232929H, PKX233314H, PKX234501H, PKX234502H, PKX234503H, PKX237381H, PKX237387H, PKX237388H, PKX238208H, PKX239835H, PKX221399H, PKX221574H, PKX222079H, PKX222080H, PKX224513H, PKX224514H, PKX224516H, PKX227324H, PKX227345H, PKX227682H, PKX228904H, PKX228906H, PKX228908H, PKX228909H, PKX228910H, PKX228911H, PKX228913H, PKX228914H, PKX229853H, PKX231241H, PKX231252H, PKX231254H, PKX231649H, PKX236716H, PKX237149H, PKX239857H, PKX239859H, PKX222843H, PKX222911H, PKX228365H, PKX238286H, PKX238309H, PKX240476H, PKX222800H, PKX223034H, PKX223035H, PKX226295H, PKX226474H, PKX227208H, PKX233312H, PKX236151H, PKX238754H, PKX240371H, PKX240713H, PKX222391H, PKX222460H, PKX222472H, PKX224460H, PKX224461H, PKX224463H, PKX226433H, PKX227399H, PKX227400H, PKX227402H, PKX229436H, PKX229445H, PKX229449H, PKX231620H, PKX231622H, PKX231626H, PKX238237H, PKX231100H, PKX238192H, PKX224183H, PKX225131H, PKX227025H, PKX230044H, PKX230187H, PKX231975H, PKX233089H, PKX234205H, PKX237531H, PKX240668H, PKX236754H, PKX233732H, PKX224018H, PKX228731H, PKX235573H, PKX226764H, PKX227712H, PKX233798H, PKX234905H, PKX239269H, PKX228679H, PKX235579H, PKX220404H, PKX220493H, PKX221484H, PKX223303H, PKX225241H, PKX229603H, PKX229714H, PKX229866H, PKX232580H, PKX232802H, PKX233423H, PKX234682H, PKX235413H, PKX235417H, PKX235485H, PKX235694H, PKX236172H, PKX237673H, PKX237898H, PKX238170H, PKX238354H, PKX238430H, PKX238598H, PKX238613H, PKX238728H, PKX238845H, PKX238871H, PKX220148H, PKX220889H, PKX227386H, PKX228609H, PKX233630H, PKX239951H, PKX223961H, PKX238088H, PKX218836H, PKX220296H, PKX222349H, PKX226042H, PKX226439H, PKX226937H, PKX229214H, PKX229485H, PKX229664H, PKX229764H, PKX229784H, PKX229847H, PKX229857H, PKX230158H, PKX237941H, PKX219686H, PKX222215H, PKX223311H, PKX223992H, PKX227487H, PKX227558H, PKX227967H, PKX231101H, PKX232373H, PKX222534H, PKX239017H, PKX239821H, PKX218790H, PKX218820H, PKX219624H, PKX219668H, PKX219701H, PKX219830H, PKX219932H, PKX219942H, PKX220238H, PKX220255H, PKX220458H, PKX220866H, PKX220983H, PKX221229H, PKX221428H, PKX221458H, PKX221494H, PKX222396H, PKX222764H, PKX223043H, PKX223044H, PKX223255H, PKX223483H, PKX223726H, PKX224294H, PKX225178H, PKX225317H, PKX225658H, PKX225758H, PKX226614H, PKX227551H, PKX227684H, PKX227926H, PKX228125H, PKX228296H, PKX229538H, PKX230193H, PKX230371H, PKX230897H, PKX232600H, PKX232691H, PKX233714H, PKX234030H, PKX236066H, PKX236085H, PKX237169H, PKX237865H, PKX238125H, PKX238337H, PKX238614H, PKX238668H, PKX238695H, PKX238725H, PKX238770H, PKX239851H, PKX239852H, PKX218785H, PKX218866H, PKX219886H, PKX220152H, PKX220401H, PKX220871H, PKX221301H, PKX221459H, PKX223003H, PKX223478H, PKX224158H, PKX224305H, PKX224549H, PKX225739H, PKX225754H, PKX225776H, PKX226321H, PKX226377H, PKX226685H, PKX226744H, PKX227879H, PKX228500H, PKX228519H, PKX229332H, PKX229567H, PKX230213H, PKX230400H, PKX230403H, PKX232931H, PKX233503H, PKX233908H, PKX234679H, PKX235120H, PKX236055H, PKX236075H, PKX236142H, PKX238068H, PKX238621H, PKX238779H, PKX239308H, PKX240413H, PKX240645H, PKX220125H, PKX221130H, PKX221131H, PKX222537H, PKX224038H, PKX224869H, PKX225439H, PKX226692H, PKX229306H, PKX229307H, PKX229309H, PKX230694H, PKX232339H, PKX232342H, PKX232345H, PKX232454H, PKX232456H, PKX233212H, PKX234302H, PKX234348H, PKX234352H, PKX234353H, PKX234372H, PKX234380H, PKX234381H, PKX235612H, PKX236775H, PKX236776H, PKX236779H, PKX236780H, PKX237303H, PKX237823H, PKX238856H, PKX2...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

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.

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 the record says

Lot and product identifiers

Distribution

Dates in the source

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