Recall archive / FDA device enforcement

ICD-VR DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; Implantable Cardioverter Defibrillators — FDA record Z-1811-2023

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 DVMB2D4 EVERA MRI XT DF4 INTL, Model Number DVMB2D4; 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: 6477 units
Agency-reported status: Ongoing
Source record identifier: Z-1811-2023

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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PLZ612321S, PLZ612324S, PLZ612325S, PLZ612358S, PLZ612368S, PLZ612375S, PLZ6...

Label field

Details supplied by the agency

Lot, code or applicability

GTIN 00643169720565, Lot Serial Numbers: PLZ611718S, PLZ611713S, PLZ611719S, PLZ613233S, PLZ613240S, PLZ613268S, PLZ613269S, PLZ613270S, PLZ610634S, PLZ612616S, PLZ613234S, PLZ610657S, PLZ611892S, PLZ610319S, PLZ610320S, PLZ610622S, PLZ610625S, PLZ610626S, PLZ610627S, PLZ610631S, PLZ610670S, PLZ610671S, PLZ610672S, PLZ610988S, PLZ610990S, PLZ610992S, PLZ611154S, PLZ611155S, PLZ611159S, PLZ611202S, PLZ611643S, PLZ611644S, PLZ611645S, PLZ611815S, PLZ611819S, PLZ611822S, PLZ611889S, PLZ611890S, PLZ611891S, PLZ610001S, PLZ611744S, PLZ610666S, PLZ613301S, PLZ613302S, PLZ611722S, PLZ611738S, PLZ611741S, PLZ611923S, PLZ612176S, PLZ613231S, PLZ613236S, PLZ613237S, PLZ613250S, PLZ613282S, PLZ613288S, PLZ613298S, PLZ611726S, PLZ611728S, PLZ613246S, PLZ613247S, PLZ613248S, PLZ610991S, PLZ611759S, PLZ611768S, PLZ610684S, PLZ610986S, PLZ610515S, PLZ610989S, PLZ611145S, PLZ611716S, PLZ611116S, PLZ611707S, PLZ611714S, PLZ610471S, PLZ610996S, PLZ613221S, PLZ613223S, PLZ613224S, PLZ613225S, PLZ613226S, PLZ613227S, PLZ613228S, PLZ610496S, PLZ611729S, PLZ613235S, PLZ613279S, PLZ613296S, PLZ610318S, PLZ610326S, PLZ610352S, PLZ610458S, PLZ610459S, PLZ611004S, PLZ611730S, PLZ611922S, PLZ612232S, PLZ612654S, PLZ612815S, PLZ613229S, PLZ613230S, PLZ613238S, PLZ613239S, PLZ613244S, PLZ613245S, PLZ613265S, PLZ613271S, PLZ613274S, PLZ613275S, PLZ613276S, PLZ613283S, PLZ613285S, PLZ613287S, PLZ613293S, PLZ613294S, PLZ613309S, PLZ613291S, PLZ610995S, PLZ611747S, PLZ611748S, PLZ611920S, PLZ611921S, PLZ613251S, PLZ613277S, PLZ613278S, PLZ613289S, PLZ613290S, PLZ613242S, PLZ612824S, PLZ613264S, PLZ613280S, PLZ613292S, PLZ613297S, PLZ613303S, PLZ611919S, PLZ611755S, PLZ611778S, PLZ611752S, PLZ610985S, PLZ613281S, PLZ610477S, PLZ610478S, PLZ610479S, PLZ610480S, PLZ610481S, PLZ610482S, PLZ610483S, PLZ610484S, PLZ610485S, PLZ610486S, PLZ610487S, PLZ610488S, PLZ610489S, PLZ610490S, PLZ610491S, PLZ610492S, PLZ610493S, PLZ610494S, PLZ610495S, PLZ610504S, PLZ610505S, PLZ610506S, PLZ610507S, PLZ610508S, PLZ610509S, PLZ610512S, PLZ610514S, PLZ610516S, PLZ610520S, PLZ610522S, PLZ610545S, PLZ610546S, PLZ610587S, PLZ612108S, PLZ612109S, PLZ612111S, PLZ612115S, PLZ612116S, PLZ612118S, PLZ612137S, PLZ612139S, PLZ612141S, PLZ612142S, PLZ612143S, PLZ612144S, PLZ612145S, PLZ612146S, PLZ612147S, PLZ612148S, PLZ612149S, PLZ612150S, PLZ612151S, PLZ612152S, PLZ612153S, PLZ612155S, PLZ612157S, PLZ612158S, PLZ612159S, PLZ612160S, PLZ612161S, PLZ612162S, PLZ612163S, PLZ612164S, PLZ612165S, PLZ612166S, PLZ612167S, PLZ612168S, PLZ612169S, PLZ612170S, PLZ612171S, PLZ612172S, PLZ612349S, PLZ612365S, PLZ613286S, PLZ613304S, PLZ613305S, PLZ610524S, PLZ610777S, PLZ611008S, PLZ611895S, PLZ611924S, PLZ611926S, PLZ611928S, PLZ611929S, PLZ611930S, PLZ612156S, PLZ612687S, PLZ612799S, PLZ612811S, PLZ612812S, PLZ612816S, PLZ612820S, PLZ612821S, PLZ613256S, PLZ613257S, PLZ613258S, PLZ613259S, PLZ613260S, PLZ613261S, PLZ613262S, PLZ613311S, PLZ610353S, PLZ612089S, PLZ612090S, PLZ612107S, PLZ612154S, PLZ612615S, PLZ613306S, PLZ613307S, PLZ610961S, PLZ610980S, PLZ611010S, PLZ611112S, PLZ611114S, PLZ611168S, PLZ611169S, PLZ611619S, PLZ611686S, PLZ612091S, PLZ612092S, PLZ612380S, PLZ612381S, PLZ612382S, PLZ610351S, PLZ610355S, PLZ610718S, PLZ610720S, PLZ610887S, PLZ610894S, PLZ610895S, PLZ610896S, PLZ610897S, PLZ610898S, PLZ610788S, PLZ610791S, PLZ610793S, PLZ610915S, PLZ610916S, PLZ610937S, PLZ610939S, PLZ610940S, PLZ611176S, PLZ611178S, PLZ611182S, PLZ610782S, PLZ610867S, PLZ610882S, PLZ610906S, PLZ610910S, PLZ610912S, PLZ610943S, PLZ610993S, PLZ611067S, PLZ611070S, PLZ612112S, PLZ612117S, PLZ612124S, PLZ612125S, PLZ612134S, PLZ612254S, PLZ612255S, PLZ612257S, PLZ612261S, PLZ612286S, PLZ612295S, PLZ612356S, PLZ612360S, PLZ612362S, PLZ612607S, PLZ612647S, PLZ612664S, PLZ612671S, PLZ612672S, PLZ612683S, PLZ612685S, PLZ612692S, PLZ612800S, PLZ612802S, PLZ612809S, PLZ610920S, PLZ612378S, PLZ612665S, PLZ610836S, PLZ610843S, PLZ610913S, PLZ610914S, PLZ610936S, PLZ611059S, PLZ611065S, PLZ611185S, PLZ611190S, PLZ611198S, PLZ611201S, PLZ611693S, PLZ611696S, PLZ611740S, PLZ612119S, PLZ612290S, PLZ612310S, PLZ612666S, PLZ612673S, PLZ612681S, PLZ610893S, PLZ610911S, PLZ610950S, PLZ611173S, PLZ612127S, PLZ612301S, PLZ612318S, PLZ612694S, PLZ610864S, PLZ610885S, PLZ610886S, PLZ612138S, PLZ612288S, PLZ612315S, PLZ612797S, PLZ610928S, PLZ610932S, PLZ610933S, PLZ612653S, PLZ612655S, PLZ610891S, PLZ610827S, PLZ610828S, PLZ610829S, PLZ610830S, PLZ610831S, PLZ610832S, PLZ610833S, PLZ610834S, PLZ610837S, PLZ610840S, PLZ610841S, PLZ610842S, PLZ612113S, PLZ612114S, PLZ612121S, PLZ612122S, PLZ612123S, PLZ612130S, PLZ612227S, PLZ612231S, PLZ612236S, PLZ612237S, PLZ612256S, PLZ612258S, PLZ612264S, PLZ612269S, PLZ612270S, PLZ612271S, PLZ612276S, PLZ612284S, PLZ612285S, PLZ612306S, PLZ612312S, PLZ612313S, PLZ612314S, PLZ612316S, PLZ612317S, PLZ612319S, PLZ612320S, PLZ612322S, PLZ612323S, PLZ612327S, PLZ612328S, PLZ612332S, PLZ612338S, PLZ612359S, PLZ612645S, PLZ612648S, PLZ612659S, PLZ612660S, PLZ612662S, PLZ612670S, PLZ612689S, PLZ612810S, PLZ610356S, PLZ611700S, PLZ612131S, PLZ612656S, PLZ612233S, PLZ612262S, PLZ612287S, PLZ612649S, PLZ612661S, PLZ610364S, PLZ610473S, PLZ610890S, PLZ610856S, PLZ610907S, PLZ611071S, PLZ611183S, PLZ612120S, PLZ612223S, PLZ612277S, PLZ612292S, PLZ612294S, PLZ612335S, PLZ612644S, PLZ612658S, PLZ612675S, PLZ612684S, PLZ612691S, PLZ612817S, PLZ612818S, PLZ612823S, PLZ610324S, PLZ610778S, PLZ610849S, PLZ610863S, PLZ610884S, PLZ610923S, PLZ611068S, PLZ611192S, PLZ611196S, PLZ611676S, PLZ611690S, PLZ611704S, PLZ611727S, PLZ612126S, PLZ612133S, PLZ612234S, PLZ612280S, PLZ612307S, PLZ612610S, PLZ612646S, PLZ612798S, PLZ612805S, PLZ612806S, PLZ610321S, PLZ610350S, PLZ610354S, PLZ610361S, PLZ610523S, PLZ610725S, PLZ610772S, PLZ610789S, PLZ610835S, PLZ610844S, PLZ610845S, PLZ610847S, PLZ610848S, PLZ610857S, PLZ610858S, PLZ610865S, PLZ610866S, PLZ610868S, PLZ610869S, PLZ610870S, PLZ610871S, PLZ610872S, PLZ610873S, PLZ610876S, PLZ610878S, PLZ610879S, PLZ610880S, PLZ610881S, PLZ610883S, PLZ610888S, PLZ610889S, PLZ610892S, PLZ610899S, PLZ610901S, PLZ610902S, PLZ610903S, PLZ610904S, PLZ610908S, PLZ610909S, PLZ610918S, PLZ610919S, PLZ610925S, PLZ610926S, PLZ610946S, PLZ610948S, PLZ610952S, PLZ611061S, PLZ611194S, PLZ611195S, PLZ611670S, PLZ611674S, PLZ611677S, PLZ611688S, PLZ611701S, PLZ611706S, PLZ611710S, PLZ612110S, PLZ612128S, PLZ612129S, PLZ612135S, PLZ612136S, PLZ612177S, PLZ612220S, PLZ612228S, PLZ612235S, PLZ612265S, PLZ612267S, PLZ612268S, PLZ612272S, PLZ612273S, PLZ612278S, PLZ612279S, PLZ612289S, PLZ612291S, PLZ612300S, PLZ612303S, PLZ612304S, PLZ612305S, PLZ612308S, PLZ612309S, PLZ612311S, PLZ612326S, PLZ612386S, PLZ612650S, PLZ612663S, PLZ612667S, PLZ612668S, PLZ612669S, PLZ612676S, PLZ612677S, PLZ612678S, PLZ612679S, PLZ612680S, PLZ612686S, PLZ612688S, PLZ612690S, PLZ612801S, PLZ612803S, PLZ612804S, PLZ612807S, PLZ612808S, PLZ612813S, PLZ612822S, PLZ611609S, PLZ611687S, PLZ611144S, PLZ612259S, PLZ612263S, PLZ610457S, PLZ610460S, PLZ610461S, PLZ610462S, PLZ610463S, PLZ610464S, PLZ610467S, PLZ610474S, PLZ610475S, PLZ610476S, PLZ610497S, PLZ610498S, PLZ610499S, PLZ610501S, PLZ610503S, PLZ611932S, PLZ611013S, PLZ611011S, PLZ611016S, PLZ610647S, PLZ610664S, PLZ611115S, PLZ612260S, PLZ612282S, PLZ612339S, PLZ612657S, PLZ610673S, PLZ610624S, PLZ610628S, PLZ610629S, PLZ610917S, PLZ610983S, PLZ610466S, PLZ610623S, PLZ610997S, PLZ610998S, PLZ610322S, PLZ610621S, PLZ611629S, PLZ610654S, PLZ610770S, PLZ610968S, PLZ610978S, PLZ611631S, PLZ611673S, PLZ611675S, PLZ611678S, PLZ611679S, PLZ611705S, PLZ611721S, PLZ612224S, PLZ612383S, PLZ612384S, PLZ611630S, PLZ611618S, PLZ610648S, PLZ610651S, PLZ610653S, PLZ610938S, PLZ610960S, PLZ610971S, PLZ610975S, PLZ611671S, PLZ611672S, PLZ612221S, PLZ612281S, PLZ612331S, PLZ612334S, PLZ612336S, PLZ612347S, PLZ611122S, PLZ611894S, PLZ611628S, PLZ612283S, PLZ612379S, PLZ612222S, PLZ611170S, PLZ611635S, PLZ611636S, PLZ611637S, PLZ611638S, PLZ611639S, PLZ611640S, PLZ611641S, PLZ611760S, PLZ611761S, PLZ611762S, PLZ611763S, PLZ611764S, PLZ611765S, PLZ611823S, PLZ611824S, PLZ611826S, PLZ611893S, PLZ612602S, PLZ612603S, PLZ613252S, PLZ613253S, PLZ613254S, PLZ613255S, PLZ612225S, PLZ610649S, PLZ610949S, PLZ610951S, PLZ610969S, PLZ610970S, PLZ611121S, PLZ611175S, PLZ611702S, PLZ611754S, PLZ611773S, PLZ611774S, PLZ611775S, PLZ611776S, PLZ610796S, PLZ611632S, PLZ611633S, PLZ610947S, PLZ610435S, PLZ610860S, PLZ610861S, PLZ610875S, PLZ610877S, PLZ611602S, PLZ612100S, PLZ610732S, PLZ610733S, PLZ610724S, PLZ610726S, PLZ610727S, PLZ610737S, PLZ610768S, PLZ610769S, PLZ611171S, PLZ611172S, PLZ611174S, PLZ611177S, PLZ611626S, PLZ611627S, PLZ611634S, PLZ611680S, PLZ611681S, PLZ611682S, PLZ611683S, PLZ611698S, PLZ611779S, PLZ612101S, PLZ612102S, PLZ612103S, PLZ612385S, PLZ612387S, PLZ612605S, PLZ612606S, PLZ612609S, PLZ612612S, PLZ612613S, PLZ612614S, PLZ613308S, PLZ611165S, PLZ611712S, PLZ613241S, PLZ613243S, PLZ613299S, PLZ610002S, PLZ610003S, PLZ610427S, PLZ610428S, PLZ610429S, PLZ610430S, PLZ610431S, PLZ610432S, PLZ610433S, PLZ610434S, PLZ611014S, PLZ610974S, PLZ611069S, PLZ611918S, PLZ613273S, PLZ610963S, PLZ610964S, PLZ610965S, PLZ610966S, PLZ610967S, PLZ610662S, PLZ611156S, PLZ610632S, PLZ610633S, PLZ610644S, PLZ610645S, PLZ610661S, PLZ610663S, PLZ610674S, PLZ610675S, PLZ610677S, PLZ610683S, PLZ610719S, PLZ610721S, PLZ610722S, PLZ610723S, PLZ611611S, PLZ611612S, PLZ611620S, PLZ611621S, PLZ611622S, PLZ611624S, PLZ611625S, PLZ611733S, PLZ611734S, PLZ611742S, PLZ611743S, PLZ611745S, PLZ611746S, PLZ611800S, PLZ611801S, PLZ611161S, PLZ611703S, PLZ612366S, PLZ612230S, PLZ610436S, PLZ610655S, PLZ610660S, PLZ610797S, PLZ610959S, PLZ610962S, PLZ610979S, PLZ611118S, PLZ611119S, PLZ611120S, PLZ611184S, PLZ611186S, PLZ611613S, PLZ611615S, PLZ611616S, PLZ611617S, PLZ611749S, PLZ610956S, PLZ611608S, PLZ611610S, PLZ611751S, PLZ611146S, PLZ610513S, PLZ610779S, PLZ610776S, PLZ611147S, PLZ611157S, PLZ611669S, PLZ611820S, PLZ611936S, PLZ612088S, PLZ612098S, PLZ610850S, PLZ610862S, PLZ611062S, PLZ611188S, PLZ611000S, PLZ611015S, PLZ610665S, PLZ610787S, PLZ612095S, PLZ612097S, PLZ611827S, PLZ611828S, PLZ610646S, PLZ611001S, PLZ611020S, PLZ611691S, PLZ611694S, PLZ611021S, PLZ611708S, PLZ611709S, PLZ611711S, PLZ613266S, PLZ613267S, PLZ610472S, PLZ611162S, PLZ610775S, PLZ610941S, PLZ611017S, PLZ610618S, PLZ610619S, PLZ610620S, PLZ610630S, PLZ610973S, PLZ611058S, PLZ611066S, PLZ611187S, PLZ611647S, PLZ611821S, PLZ611935S, PLZ611937S, PLZ610652S, PLZ610734S, PLZ611803S, PLZ610510S, PLZ611769S, PLZ610637S, PLZ610638S, PLZ610640S, PLZ610642S, PLZ610643S, PLZ610667S, PLZ610668S, PLZ610669S, PLZ610676S, PLZ610678S, PLZ610679S, PLZ610680S, PLZ610792S, PLZ611006S, PLZ611018S, PLZ611019S, PLZ611022S, PLZ611053S, PLZ611054S, PLZ611055S, PLZ611056S, PLZ611148S, PLZ611149S, PLZ611150S, PLZ610846S, PLZ610511S, PLZ610517S, PLZ610518S, PLZ610519S, PLZ610521S, PLZ610641S, PLZ610682S, PLZ610685S, PLZ610686S, PLZ610687S, PLZ610728S, PLZ610729S, PLZ610730S, PLZ610731S, PLZ610681S, PLZ611164S, PLZ611189S, PLZ611199S, PLZ611200S, PLZ611600S, PLZ611772S, PLZ611802S, PLZ610955S, PLZ610957S, PLZ610958S, PLZ610972S, PLZ610981S, PLZ610982S, PLZ610984S, PLZ610987S, PLZ611151S, PLZ611152S, PLZ611601S, PLZ611689S, PLZ611692S, PLZ611695S, PLZ611697S, PLZ611735S, PLZ611736S, PLZ611737S, PLZ611739S, PLZ611805S, PLZ611808S, PLZ611809S, PLZ611896S, PLZ611897S, PLZ611925S, PLZ611927S, PLZ611931S, PLZ611934S, PLZ612094S, PLZ612096S, PLZ610785S, PLZ610786S, PLZ610838S, PLZ611191S, PLZ611193S, PLZ611197S, PLZ611766S, PLZ611767S, PLZ611770S, PLZ611771S, PLZ611806S, PLZ611807S, PLZ611804S, PLZ610735S, PLZ610736S, PLZ610994S, PLZ611153S, PLZ610656S, PLZ610839S, PLZ610636S, PLZ610781S, PLZ610650S, PLZ611158S, PLZ611646S, PLZ610790S, PLZ611063S, PLZ611064S, PLZ611723S, PLZ611724S, PLZ611725S, PLZ611731S, PLZ611732S, PLZ612093S, PLZ612104S, PLZ612105S, PLZ612106S, PLZ612173S, PLZ612174S, PLZ612175S, PLZ612274S, PLZ612302S, PLZ612321S, PLZ612324S, PLZ612325S, PLZ612358S, PLZ612368S, PLZ612375S, PLZ6...

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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