Recall archive / FDA device enforcement

ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter Defibrillators — FDA record Z-1710-2023

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-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; 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: 4056 units
Agency-reported status: Ongoing
Source record identifier: Z-1710-2023

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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BWF605653S, BWF605655S, BWF605656S, BWF605695S, BWF605749S, BWF605750S,...

Label field

Details supplied by the agency

Lot, code or applicability

GTIN 00643169720381, Lot Serial Numbers: BWF206541H, BWF206448H, BWF206403H, BWF206382H, BWF206552H, BWF206320H, BWF206323H, BWF206420H, BWF206376H, BWF206458H, BWF206459H, BWF206430H, BWF206453H, BWF206359H, BWF206478H, BWF206333H, BWF206365H, BWF206370H, BWF206557H, BWF206599H, BWF206607H, BWF206551H, BWF206367H, BWF206396H, BWF206421H, BWF206554H, BWF206355H, BWF206461H, BWF206604H, BWF206371H, BWF206373H, BWF206374H, BWF206378H, BWF206380H, BWF206381H, BWF206383H, BWF206387H, BWF206388H, BWF206390H, BWF206449H, BWF206473H, BWF206474H, BWF206475H, BWF206500H, BWF206526H, BWF206527H, BWF206528H, BWF206529H, BWF206535H, BWF206563H, BWF206565H, BWF206567H, BWF206568H, BWF206573H, BWF206574H, BWF206575H, BWF206597H, BWF206598H, BWF206175H, BWF206419H, BWF206327H, BWF206491H, BWF206496H, BWF206401H, BWF206321H, BWF206334H, BWF206338H, BWF206344H, BWF206432H, BWF206470H, BWF206489H, BWF206507H, BWF206558H, BWF206577H, BWF206583H, BWF206570H, BWF206581H, BWF206342H, BWF206410H, BWF206492H, BWF206417H, BWF206424H, BWF206476H, BWF206539H, BWF206580H, BWF206485H, BWF206608H, BWF206601H, BWF206317H, BWF206384H, BWF206395H, BWF206490H, BWF206585H, BWF206590H, BWF206322H, BWF206431H, BWF206443H, BWF206463H, BWF206484H, BWF206487H, BWF206497H, BWF206502H, BWF206505H, BWF206534H, BWF206553H, BWF206569H, BWF206571H, BWF206415H, BWF206451H, BWF206452H, BWF206544H, BWF206546H, BWF206460H, BWF206360H, BWF206440H, BWF206462H, BWF206340H, BWF206435H, BWF206510H, BWF206495H, BWF206375H, BWF206405H, BWF206418H, BWF206454H, BWF206465H, BWF206488H, BWF206358H, BWF206353H, BWF206397H, BWF206582H, BWF206176H, BWF206456H, BWF206589H, BWF206412H, BWF206369H, BWF206394H, BWF206426H, BWF206398H, BWF206578H, BWF206425H, BWF206318H, BWF206402H, BWF206584H, BWF206357H, BWF206400H, BWF206409H, BWF206341H, BWF206428H, BWF206392H, BWF206393H, BWF206416H, BWF206427H, BWF206437H, BWF206441H, BWF206518H, BWF206530H, BWF206533H, BWF206345H, BWF206455H, BWF206457H, BWF206594H, BWF206602H, BWF206548H, BWF206536H, BWF206347H, BWF206349H, BWF206408H, BWF206429H, BWF206434H, BWF206506H, BWF206572H, BWF206576H, BWF206587H, BWF206588H, BWF206361H, BWF206362H; GTIN 00643169720398, Lot Serial Numbers: BWF606744S, BWF606741S, BWF606219S, BWF606448S, BWF606453S, BWF606410S, BWF605918S, BWF605872S, BWF606271S, BWF605623S, BWF606336S, BWF606345S, BWF605908S, BWF605763S, BWF605654S, BWF606234S, BWF605707S, BWF605912S, BWF606049S, BWF606062S, BWF606087S, BWF606199S, BWF606352S, BWF606469S, BWF606509S, BWF605447S, BWF605448S, BWF605678S, BWF605680S, BWF606689S, BWF606695S, BWF607268S, BWF605619S, BWF606242S, BWF606472S, BWF606562S, BWF606761S, BWF605624S, BWF605625S, BWF605662S, BWF605665S, BWF606343S, BWF606613S, BWF606749S, BWF605703S, BWF605762S, BWF606269S, BWF606353S, BWF605636S, BWF606233S, BWF606703S, BWF606763S, BWF606220S, BWF605870S, BWF605664S, BWF605767S, BWF606481S, BWF605630S, BWF605917S, BWF606115S, BWF606223S, BWF606211S, BWF606239S, BWF606532S, BWF605867S, BWF605668S, BWF605628S, BWF605629S, BWF606104S, BWF606106S, BWF606327S, BWF606330S, BWF606441S, BWF606442S, BWF606737S, BWF606766S, BWF605700S, BWF606624S, BWF606750S, BWF605673S, BWF605681S, BWF606622S, BWF605754S, BWF606270S, BWF606385S, BWF606685S, BWF606625S, BWF605635S, BWF605663S, BWF605909S, BWF606493S, BWF606351S, BWF606094S, BWF606447S, BWF606454S, BWF606767S, BWF606768S, BWF605670S, BWF605877S, BWF605904S, BWF606341S, BWF606222S, BWF606152S, BWF606183S, BWF606185S, BWF606186S, BWF606285S, BWF606294S, BWF606318S, BWF606321S, BWF606322S, BWF606324S, BWF606512S, BWF606530S, BWF606542S, BWF606544S, BWF606597S, BWF606610S, BWF606455S, BWF606457S, BWF606163S, BWF606177S, BWF606179S, BWF606510S, BWF606516S, BWF606531S, BWF606534S, BWF606539S, BWF606541S, BWF605671S, BWF605756S, BWF605688S, BWF605689S, BWF606244S, BWF606187S, BWF606762S, BWF607611S, BWF607573S, BWF605959S, BWF606249S, BWF606333S, BWF606411S, BWF605702S, BWF606759S, BWF606764S, BWF606753S, BWF606758S, BWF605659S, BWF605660S, BWF605661S, BWF605704S, BWF605900S, BWF606235S, BWF606511S, BWF606440S, BWF606700S, BWF606739S, BWF605691S, BWF605631S, BWF605634S, BWF605672S, BWF606342S, BWF606523S, BWF605738S, BWF606438S, BWF605706S, BWF605901S, BWF605757S, BWF605758S, BWF605879S, BWF605880S, BWF605915S, BWF605919S, BWF605921S, BWF605923S, BWF606491S, BWF606492S, BWF605666S, BWF606101S, BWF605910S, BWF605718S, BWF605868S, BWF605674S, BWF606096S, BWF607589S, BWF606295S, BWF606334S, BWF606350S, BWF606757S, BWF605978S, BWF606557S, BWF605677S, BWF605679S, BWF605683S, BWF605687S, BWF605692S, BWF605822S, BWF605838S, BWF606589S, BWF606596S, BWF606600S, BWF606614S, BWF606960S, BWF607227S, BWF605824S, BWF605825S, BWF606421S, BWF606601S, BWF606602S, BWF606605S, BWF606812S, BWF606815S, BWF606889S, BWF606890S, BWF606948S, BWF606959S, BWF606962S, BWF607132S, BWF607134S, BWF607240S, BWF607270S, BWF607319S, BWF605806S, BWF605808S, BWF605809S, BWF605810S, BWF605821S, BWF605827S, BWF605834S, BWF605835S, BWF605840S, BWF606891S, BWF606903S, BWF605627S, BWF606496S, BWF605699S, BWF605713S, BWF605714S, BWF605715S, BWF605759S, BWF605760S, BWF605761S, BWF605764S, BWF605765S, BWF605826S, BWF605828S, BWF605831S, BWF605924S, BWF605953S, BWF605987S, BWF605989S, BWF605990S, BWF605991S, BWF606010S, BWF606011S, BWF606020S, BWF606021S, BWF606025S, BWF606029S, BWF606034S, BWF606044S, BWF606045S, BWF606046S, BWF606047S, BWF606048S, BWF606071S, BWF606078S, BWF606082S, BWF606084S, BWF606085S, BWF606107S, BWF606128S, BWF606133S, BWF606134S, BWF606140S, BWF606141S, BWF606142S, BWF606147S, BWF606148S, BWF606149S, BWF606150S, BWF606157S, BWF606171S, BWF606174S, BWF606175S, BWF606176S, BWF606178S, BWF606201S, BWF606204S, BWF606207S, BWF606691S, BWF606692S, BWF606693S, BWF606745S, BWF606746S, BWF606805S, BWF606806S, BWF606807S, BWF606810S, BWF607008S, BWF607009S, BWF607010S, BWF607076S, BWF607077S, BWF607078S, BWF607097S, BWF607098S, BWF607099S, BWF607100S, BWF607101S, BWF607127S, BWF607128S, BWF607130S, BWF607131S, BWF607133S, BWF607144S, BWF607185S, BWF607186S, BWF607192S, BWF607193S, BWF607194S, BWF607225S, BWF607226S, BWF607229S, BWF607230S, BWF607231S, BWF607242S, BWF607243S, BWF607244S, BWF607247S, BWF607252S, BWF607253S, BWF607254S, BWF607255S, BWF607256S, BWF607285S, BWF607286S, BWF607287S, BWF607318S, BWF607320S, BWF607321S, BWF607322S, BWF607323S, BWF607334S, BWF607447S, BWF607490S, BWF607491S, BWF607495S, BWF607496S, BWF607497S, BWF607498S, BWF607499S, BWF607518S, BWF607519S, BWF607520S, BWF607521S, BWF607522S, BWF607545S, BWF607546S, BWF607547S, BWF607550S, BWF607551S, BWF607552S, BWF607553S, BWF607554S, BWF607557S, BWF607558S, BWF607559S, BWF607560S, BWF607564S, BWF607567S, BWF607568S, BWF607569S, BWF607570S, BWF607571S, BWF607577S, BWF607578S, BWF607579S, BWF607580S, BWF607581S, BWF607583S, BWF607584S, BWF607585S, BWF607586S, BWF607587S, BWF607588S, BWF607590S, BWF607591S, BWF607592S, BWF607593S, BWF607594S, BWF607595S, BWF607597S, BWF607598S, BWF607599S, BWF607600S, BWF607601S, BWF605643S, BWF605637S, BWF605684S, BWF605708S, BWF605710S, BWF605733S, BWF605734S, BWF605735S, BWF605736S, BWF605737S, BWF605739S, BWF605740S, BWF605741S, BWF605742S, BWF605743S, BWF605744S, BWF605745S, BWF605746S, BWF605747S, BWF605748S, BWF605751S, BWF605766S, BWF605784S, BWF605802S, BWF605803S, BWF605903S, BWF605906S, BWF605911S, BWF605922S, BWF605949S, BWF605960S, BWF605961S, BWF605962S, BWF605965S, BWF605966S, BWF605967S, BWF605968S, BWF605969S, BWF606012S, BWF606013S, BWF606036S, BWF606037S, BWF606090S, BWF606098S, BWF606105S, BWF606113S, BWF606114S, BWF606116S, BWF606117S, BWF606118S, BWF606119S, BWF606120S, BWF606122S, BWF606123S, BWF606124S, BWF606125S, BWF606126S, BWF606143S, BWF606144S, BWF606146S, BWF606156S, BWF606168S, BWF606169S, BWF606180S, BWF606182S, BWF606184S, BWF606188S, BWF606189S, BWF606190S, BWF606686S, BWF606687S, BWF606688S, BWF606690S, BWF606697S, BWF606698S, BWF606704S, BWF606735S, BWF606743S, BWF606823S, BWF606824S, BWF606885S, BWF606886S, BWF606888S, BWF607012S, BWF607013S, BWF607014S, BWF607015S, BWF607016S, BWF607017S, BWF607018S, BWF607079S, BWF607080S, BWF607089S, BWF607090S, BWF607091S, BWF607092S, BWF607135S, BWF607141S, BWF607142S, BWF607260S, BWF607261S, BWF607265S, BWF607266S, BWF607267S, BWF607269S, BWF607271S, BWF607272S, BWF607273S, BWF607274S, BWF607278S, BWF607280S, BWF607281S, BWF607282S, BWF607283S, BWF607284S, BWF607291S, BWF607292S, BWF607293S, BWF607294S, BWF607327S, BWF607328S, BWF607331S, BWF607332S, BWF607449S, BWF607451S, BWF607452S, BWF607454S, BWF607455S, BWF607456S, BWF607458S, BWF607460S, BWF607461S, BWF607462S, BWF606306S, BWF605652S, BWF605626S, BWF605633S, BWF605645S, BWF606515S, BWF606519S, BWF606520S, BWF606521S, BWF606528S, BWF606536S, BWF606546S, BWF606547S, BWF606549S, BWF606556S, BWF606558S, BWF605640S, BWF605642S, BWF605650S, BWF606524S, BWF606517S, BWF606518S, BWF606099S, BWF606145S, BWF606153S, BWF605770S, BWF605805S, BWF605807S, BWF605820S, BWF605823S, BWF605830S, BWF605836S, BWF605837S, BWF605845S, BWF606240S, BWF606537S, BWF606559S, BWF606181S, BWF606543S, BWF605685S, BWF605907S, BWF605769S, BWF605789S, BWF605793S, BWF605871S, BWF605925S, BWF605938S, BWF605939S, BWF605941S, BWF605942S, BWF605944S, BWF605946S, BWF605957S, BWF606050S, BWF606051S, BWF606052S, BWF606053S, BWF606054S, BWF606055S, BWF606056S, BWF606057S, BWF606058S, BWF606059S, BWF606191S, BWF606205S, BWF606255S, BWF606256S, BWF606289S, BWF606291S, BWF606293S, BWF606298S, BWF606299S, BWF606300S, BWF606303S, BWF606305S, BWF606307S, BWF606347S, BWF606431S, BWF606433S, BWF606434S, BWF606436S, BWF605669S, BWF605778S, BWF605783S, BWF605785S, BWF605787S, BWF605878S, BWF605931S, BWF605932S, BWF605933S, BWF605935S, BWF605936S, BWF605937S, BWF605947S, BWF605954S, BWF605955S, BWF605956S, BWF606348S, BWF606354S, BWF606355S, BWF606356S, BWF606357S, BWF606358S, BWF606359S, BWF606360S, BWF606361S, BWF606362S, BWF606363S, BWF606364S, BWF605620S, BWF605720S, BWF606482S, BWF606162S, BWF607315S, BWF605913S, BWF606751S, BWF605771S, BWF605772S, 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BWF606088S, BWF606089S, BWF606108S, BWF606109S, BWF606110S, BWF606164S, BWF606165S, BWF606135S, BWF606893S, BWF606945S, BWF605446S, BWF605632S, BWF605622S, BWF605676S, BWF605693S, BWF605694S, BWF605696S, BWF605811S, BWF605814S, BWF605817S, BWF605829S, BWF605832S, BWF606383S, BWF606406S, BWF606427S, BWF606591S, BWF606607S, BWF606774S, BWF606808S, BWF606809S, BWF606818S, BWF606822S, BWF606887S, BWF606894S, BWF606895S, BWF606897S, BWF606946S, BWF606951S, BWF606963S, BWF605841S, BWF605799S, BWF605800S, BWF605801S, BWF605812S, BWF606022S, BWF606030S, BWF606033S, BWF606039S, BWF606040S, BWF606081S, BWF606103S, BWF606151S, BWF606154S, BWF606155S, BWF606170S, BWF606699S, BWF606901S, BWF606902S, BWF607125S, BWF607126S, BWF607136S, BWF607137S, BWF607241S, BWF607245S, BWF607246S, BWF607251S, BWF607448S, BWF607450S, BWF607453S, BWF607470S, BWF607471S, BWF607612S, BWF605639S, BWF605641S, BWF605644S, BWF605646S, BWF605647S, BWF605648S, BWF605649S, BWF605651S, BWF605653S, BWF605655S, BWF605656S, BWF605695S, BWF605749S, BWF605750S,...

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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