Recall archive / FDA device enforcement
ICD-VR DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; Implantable Cardioverter Defibrillators — FDA record Z-1797-2023
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 DVBB2D1 EVERA XT IS1/DF1 INTL, Model Number DVBB2D1; 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
- 1354 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1797-2023
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 |
|---|---|
| Lot, code or applicability | GTIN 00643169218017, Lot Serial numbers: BWK607537S, BWK607358S, BWK607401S, BWK607460S, BWK607496S, BWK607540S, BWK607351S, BWK607371S, BWK607254S, BWK607394S, BWK607446S, BWK607457S, BWK607473S, BWK607498S, BWK607503S, BWK607536S, BWK607381S, BWK607393S, BWK607369S, BWK607474S, BWK607432S, BWK607439S, BWK607523S, BWK607448S, BWK607526S, BWK607383S, BWK607434S, BWK607463S, BWK607360S, BWK607437S, BWK607472S, BWK607451S, BWK607449S, BWK607436S, BWK607527S, BWK607361S, BWK607275S, BWK607326S, BWK607343S, BWK607384S, BWK607391S, BWK607479S, BWK607501S, BWK607507S, BWK607508S, BWK607518S, BWK607520S, BWK607535S, BWK607544S, BWK607327S, BWK607379S, BWK607521S, BWK607382S, BWK607502S, BWK607366S, BWK607386S, BWK607441S, BWK607468S, BWK607497S, BWK607465S, BWK607455S, BWK607470S, BWK607376S, BWK607529S, BWK607456S, BWK607509S, BWK607505S, BWK607378S, BWK607444S, BWK607297S, BWK607348S, BWK607447S, BWK607395S, BWK607464S, BWK607485S, BWK607534S, BWK607442S, BWK607347S, BWK607389S, BWK607400S, BWK607370S, BWK607438S, BWK607323S, BWK607495S, BWK607519S, BWK607368S, BWK607278S, BWK607433S, BWK607367S, BWK607499S, BWK607349S, BWK607356S, BWK607440S, BWK607458S, BWK607517S, BWK607459S, BWK607392S, BWK607450S, BWK607466S, BWK607342S, BWK607510S, BWK607445S, BWK607500S, BWK607515S, BWK607514S, BWK607533S, BWK607274S, BWK607281S, BWK607377S, BWK607506S, BWK607294S, BWK607471S, BWK607346S, BWK607307S, BWK607504S, BWK607435S, BWK607443S, BWK607399S; GTIN 00643169969582, Lot Serial Numbers: BWK607337S, BWK607219S, BWK607243S, BWK607277S, BWK607150S, BWK607222S, BWK607270S, BWK607276S, BWK607282S, BWK607285S, BWK607288S, BWK607289S, BWK607295S, BWK607330S, BWK607478S, BWK607480S, BWK607481S, BWK607482S, BWK607483S, BWK607486S, BWK607203S, BWK607205S, BWK607234S, BWK607396S, BWK607856S, BWK607600S, BWK607613S, BWK607731S, BWK607488S, BWK607490S, BWK607493S, BWK607733S, BWK607296S, BWK607217S, BWK607402S, BWK607404S, BWK607405S, BWK607484S, BWK607605S, BWK607737S, BWK607751S, BWK607214S, BWK607218S, BWK607292S, BWK607322S, BWK607334S, BWK607336S, BWK607216S, BWK607244S, BWK607250S, BWK607279S, BWK607220S, BWK607300S, BWK607420S, BWK607422S, BWK607430S, BWK607431S, BWK607476S, BWK607477S, BWK607299S, BWK607204S, BWK607229S, BWK607213S, BWK607290S, BWK607421S, BWK607608S, BWK607224S, BWK607228S, BWK607231S, BWK607238S, BWK607242S, BWK607256S, BWK607267S, BWK607286S, BWK607308S, BWK607357S, BWK607390S, BWK607551S, BWK607719S, BWK607739S, BWK607761S, BWK607764S, BWK607769S, BWK607772S, BWK607974S, BWK607977S, BWK607984S, BWK607991S, BWK607247S, BWK607260S, BWK607273S, BWK607364S, BWK607549S, BWK607552S, BWK607564S, BWK607591S, BWK607593S, BWK607596S, BWK607602S, BWK607638S, BWK607716S, BWK607746S, BWK607756S, BWK607763S, BWK607771S, BWK607780S, BWK607855S, BWK607915S, BWK607262S, BWK607272S, BWK607315S, BWK607317S, BWK607352S, BWK607380S, BWK607545S, BWK607553S, BWK607590S, BWK607743S, BWK607765S, BWK607870S, BWK607265S, BWK607268S, BWK607284S, BWK607303S, BWK607365S, BWK607492S, BWK607556S, BWK607588S, BWK607595S, BWK607599S, BWK607637S, BWK607639S, BWK607640S, BWK607758S, BWK607766S, BWK607933S, BWK607986S, BWK607226S, BWK607586S, BWK607230S, BWK607248S, BWK607249S, BWK607252S, BWK607253S, BWK607264S, BWK607287S, BWK607305S, BWK607306S, BWK607314S, BWK607320S, BWK607350S, BWK607353S, BWK607373S, BWK607374S, BWK607388S, BWK607548S, BWK607550S, BWK607589S, BWK607641S, BWK607667S, BWK607669S, BWK607670S, BWK607672S, BWK607730S, BWK607734S, BWK607747S, BWK607748S, BWK607754S, BWK607755S, BWK607757S, BWK607760S, BWK607773S, BWK607778S, BWK607779S, BWK607782S, BWK607783S, BWK607861S, BWK607869S, BWK607872S, BWK607918S, BWK607919S, BWK607921S, BWK607922S, BWK607924S, BWK607925S, BWK607931S, BWK607936S, BWK607966S, BWK607968S, BWK607970S, BWK607973S, BWK607975S, BWK607978S, BWK607979S, BWK607993S, BWK607994S, BWK607255S, BWK607585S, BWK607926S, BWK607263S, BWK607304S, BWK607359S, BWK607372S, BWK607385S, BWK607934S, BWK607344S, BWK607601S, BWK607720S, BWK607749S, BWK607774S, BWK607866S, BWK607920S, BWK607965S, BWK607967S, BWK607969S, BWK607971S, BWK607972S, BWK607981S, BWK607982S, BWK607642S, BWK607259S, BWK607363S, BWK607562S, BWK607594S, BWK607784S, BWK607929S, BWK607251S, BWK607261S, BWK607269S, BWK607355S, BWK607362S, BWK607598S, BWK607665S, BWK607750S, BWK607917S, BWK607985S, BWK607987S, BWK607988S, BWK607989S, BWK607636S, BWK607865S, BWK607916S, BWK607225S, BWK607302S, BWK607312S, BWK607375S, BWK607387S, BWK607546S, BWK607555S, BWK607635S, BWK607673S, BWK607738S, BWK607759S, BWK607867S, BWK607871S, BWK607345S, BWK607494S, BWK607512S, BWK607557S, BWK607558S, BWK607559S, BWK607560S, BWK607561S, BWK607775S, BWK607777S, BWK607245S, BWK607258S, BWK607316S, BWK607563S, BWK607597S, BWK607643S, BWK607666S, BWK607671S, BWK607715S, BWK607736S, BWK607935S, BWK607983S, BWK607992S, BWK607309S, BWK607311S, BWK607321S, BWK607674S, BWK607740S, BWK607767S, BWK607873S, BWK607923S, BWK607331S, BWK607607S, BWK607717S, BWK607723S, BWK607280S, BWK607611S, BWK607614S, BWK607728S, BWK607236S, BWK607235S, BWK607239S, BWK607329S, BWK607864S, BWK607211S, BWK607489S, BWK607491S, BWK607587S, BWK607606S, BWK607722S, BWK607863S, BWK607609S, BWK607215S, BWK607232S, BWK607332S, BWK607610S, BWK607209S, BWK607240S, BWK607475S, BWK607246S, BWK607554S, BWK607603S, BWK607333S, BWK607604S, BWK607612S, BWK607237S, BWK607592S, BWK607857S, BWK607210S, BWK607208S, BWK607241S, BWK607487S, BWK607339S, BWK607340S, BWK607338S, BWK607859S, BWK607868S, BWK607858S, BWK607354S, BWK607745S, BWK607752S, BWK607781S, BWK607874S, BWK607976S, BWK607980S, BWK607318S, BWK607724S, BWK607741S, BWK607768S, BWK607257S, BWK607927S, BWK607860S, BWK607744S, BWK607753S, BWK607762S, BWK607776S, BWK607668S, BWK607721S, BWK607227S, BWK607725S, BWK607726S, BWK607727S, BWK607729S, BWK607732S, BWK607151S, BWK607770S, BWK607990S; GTIN 00643169980242, Lot Serial Numbers: BWK608397S, BWK608751S, BWK607995S, BWK608734S, BWK608735S, BWK608737S, BWK607960S, BWK608606S, BWK607805S, BWK607680S, BWK608205S, BWK607625S, BWK607656S, BWK607624S, BWK607694S, BWK607790S, BWK607797S, BWK607812S, BWK608194S, BWK608226S, BWK608143S, BWK607574S, BWK608175S, BWK607646S, BWK607659S, BWK607660S, BWK607686S, BWK607696S, BWK607697S, BWK607699S, BWK607701S, BWK607708S, BWK607800S, BWK607801S, BWK607806S, BWK607808S, BWK607809S, BWK607811S, BWK607814S, BWK607816S, BWK607817S, BWK607822S, BWK607823S, BWK607824S, BWK607825S, BWK607850S, BWK607854S, BWK607875S, BWK607945S, BWK608035S, BWK608037S, BWK608141S, BWK608142S, BWK608220S, BWK608223S, BWK608224S, BWK608229S, BWK608278S, BWK608292S, BWK608335S, BWK608382S, BWK608385S, BWK608597S, BWK608598S, BWK608599S, BWK608600S, BWK608601S, BWK608604S, BWK608605S, BWK608607S, BWK608741S, BWK608743S, BWK607684S, BWK607689S, BWK607713S, BWK608051S, BWK607453S, BWK607815S, BWK607578S, BWK607658S, BWK607676S, BWK607677S, BWK607687S, BWK607688S, BWK607690S, BWK607910S, BWK607911S, BWK607912S, BWK607913S, BWK607914S, BWK607615S, BWK607616S, BWK608770S, BWK608088S, BWK608092S, BWK608038S, BWK608075S, BWK608078S, BWK608090S, BWK608157S, BWK608158S, BWK608159S, BWK608160S, BWK608170S, BWK608173S, BWK608191S, BWK608265S, BWK608267S, BWK608284S, BWK608572S, BWK608660S, BWK608679S, BWK608680S, BWK608688S, BWK608695S, BWK608698S, BWK608710S, BWK608711S, BWK608713S, BWK608728S, BWK608731S, BWK608745S, BWK608002S, BWK608011S, BWK608022S, BWK607997S, BWK608000S, BWK608003S, BWK608008S, BWK608009S, BWK608010S, BWK608013S, BWK608023S, BWK608024S, BWK608026S, BWK608027S, BWK608032S, BWK608033S, BWK608034S, BWK608036S, BWK608046S, BWK608059S, BWK608060S, BWK608061S, BWK608063S, BWK608068S, BWK608074S, BWK608081S, BWK608089S, BWK608095S, BWK608111S, BWK608121S, BWK608128S, BWK608155S, BWK608156S, BWK608163S, BWK608166S, BWK608174S, BWK608195S, BWK608235S, BWK608238S, BWK608243S, BWK608244S, BWK608245S, BWK608248S, BWK608249S, BWK608250S, BWK608252S, BWK608254S, BWK608261S, BWK608268S, BWK608270S, BWK608274S, BWK608275S, BWK608280S, BWK608281S, BWK608683S, BWK608738S, BWK608263S, BWK608091S, BWK607996S, BWK608001S, BWK608012S, BWK608028S, BWK608044S, BWK608064S, BWK608083S, BWK608094S, BWK608113S, BWK608132S, BWK608161S, BWK608162S, BWK608169S, BWK608182S, BWK608198S, BWK608214S, BWK608240S, BWK608258S, BWK608262S, BWK608699S, BWK608725S, BWK608727S, BWK608747S, BWK607998S, BWK608030S, BWK608041S, BWK608062S, BWK608071S, BWK608184S, BWK608231S, BWK608279S, BWK608648S, BWK608093S, BWK608004S, BWK608005S, BWK608029S, BWK608031S, BWK608123S, BWK608130S, BWK608168S, BWK608171S, BWK608211S, BWK608239S, BWK608271S, BWK608282S, BWK608689S, BWK608325S, BWK608326S, BWK608332S, BWK608348S, BWK608449S, BWK608453S, BWK608467S, BWK608472S, BWK608482S, BWK608496S, BWK608516S, BWK608559S, BWK608560S, BWK608634S, BWK608635S, BWK608345S, BWK608346S, BWK608377S, BWK608378S, BWK608289S, BWK608640S, BWK608381S, BWK608251S, BWK608253S, BWK608314S, BWK608315S, BWK608316S, BWK608317S, BWK608318S, BWK608322S, BWK608349S, BWK608350S, BWK608351S, BWK608353S, BWK608356S, BWK608360S, BWK608361S, BWK608362S, BWK608363S, BWK608364S, BWK608373S, BWK608374S, BWK608375S, BWK608376S, BWK608401S, BWK608404S, BWK608420S, BWK608422S, BWK608455S, BWK608456S, BWK608457S, BWK608458S, BWK608462S, BWK608463S, BWK608464S, BWK608468S, BWK608492S, BWK608539S, BWK608549S, BWK608550S, BWK608551S, BWK608569S, BWK608570S, BWK608571S, BWK608577S, BWK608578S, BWK608579S, BWK608580S, BWK608581S, BWK608582S, BWK608583S, BWK608588S, BWK608613S, BWK608614S, BWK608615S, BWK608616S, BWK608617S, BWK608625S, BWK608628S, BWK608636S, BWK608638S, BWK608293S, BWK608294S, BWK608428S, BWK608154S, BWK608285S, BWK608286S, BWK608287S, BWK608288S, BWK608300S, BWK608301S, BWK608302S, BWK608303S, BWK608320S, BWK608321S, BWK608339S, BWK608340S, BWK608342S, BWK608383S, BWK608384S, BWK608418S, BWK608419S, BWK608423S, BWK608440S, BWK608469S, BWK608470S, BWK608471S, BWK608481S, BWK608529S, BWK608531S, BWK608621S, BWK608639S, BWK608527S, BWK608591S, BWK608357S, BWK608389S, BWK608432S, BWK608452S, BWK608477S, BWK608509S, BWK608510S, BWK608543S, BWK608548S, BWK608566S, BWK608612S, BWK608622S, BWK608388S, BWK608405S, BWK608542S, BWK608546S, BWK608626S, BWK608487S, BWK608726S, BWK607957S, BWK608703S, BWK608203S, BWK608696S, BWK608177S, BWK608257S, BWK608040S, BWK608120S, BWK608137S, BWK607853S, BWK607928S, BWK607962S, BWK608145S, BWK608306S, BWK608333S, BWK608644S, BWK608685S, BWK608100S, BWK608047S, BWK608110S, BWK608255S, BWK608704S, BWK607834S, BWK607950S, BWK608446S, BWK608147S, BWK608189S, BWK608264S, BWK608269S, BWK608277S, BWK608708S, BWK608104S, BWK607891S, BWK608138S, BWK607938S, BWK608052S, BWK608054S, BWK608139S, BWK608421S, BWK607570S, BWK607572S, BWK608336S, BWK607963S, BWK608178S, BWK608266S, BWK607964S, BWK608207S, BWK608701S, BWK607830S, BWK607876S, BWK607932S, BWK607941S, BWK607951S, BWK607956S, BWK607961S, BWK608043S, BWK608096S, BWK608101S, BWK608102S, BWK608105S, BWK608107S, BWK608115S, BWK608116S, BWK608117S, BWK608118S, BWK608144S, BWK608187S, BWK608188S, BWK608192S, BWK608208S, BWK608256S, BWK608260S, BWK608276S, BWK608323S, BWK608398S, BWK608611S, BWK608643S, BWK608645S, BWK608646S, BWK608691S, BWK608707S, BWK608709S, BWK608723S, BWK608739S, BWK608736S, BWK608273S, BWK607827S, BWK608521S, BWK607826S, BWK607937S, BWK607940S, BWK608402S, BWK608097S, BWK608109S, BWK607905S, BWK608050S, BWK608098S, BWK608200S, BWK608435S, BWK608108S, BWK608234S, BWK608135S, BWK608341S, BWK608048S, BWK607792S, BWK608103S, BWK608099S, BWK608114S, BWK608136S, BWK608442S, BWK608039S, BWK608042S, BWK608206S, BWK608259S, BWK608746S, BWK608749S, BWK608712S, BWK608045S, BWK608148S, BWK608202S, BWK608311S, BWK607807S, BWK608291S, BWK608295S, BWK608296S, BWK608297S, BWK608298S, BWK608299S, BWK608304S, BWK608305S, BWK608307S, BWK608308S, BWK608309S, BWK608358S, BWK608359S, BWK608414S, BWK608415S, BWK608416S, BWK608417S, BWK608433S, BWK608523S, BWK608525S, BWK608526S, BWK608554S, BWK608555S, BWK608556S, BWK608557S, BWK608558S, BWK608434S, BWK608436S, BWK608... |
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.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- 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.