Recall archive / FDA device enforcement
ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter Defibrillators — FDA record Z-1709-2023
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 DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; 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
- 5176 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1709-2023
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 00643169720411, Lot Serial Numbers: BWG208720H, BWG208284H, BWG208405H, BWG208608H, BWG208700H, BWG208763H, BWG208301H, BWG208376H, BWG208406H, BWG208412H, BWG208520H, BWG208539H, BWG208652H, BWG208716H, BWG208296H, BWG208340H, BWG208484H, BWG208220H, BWG208234H, BWG208641H, BWG208702H, BWG208758H, BWG208430H, BWG208206H, BWG208215H, BWG208561H, BWG208216H, BWG208705H, BWG208502H, BWG208221H, BWG208236H, BWG208488H, BWG208403H, BWG208312H, BWG208557H, BWG208335H, BWG208530H, BWG208634H, BWG208745H, BWG208746H, BWG208249H, BWG208654H, BWG208291H, BWG208515H, BWG208596H, BWG208636H, BWG208637H, BWG208730H, BWG208757H, BWG208213H, BWG208347H, BWG208597H, BWG208605H, BWG208692H, BWG208514H, BWG208640H, BWG208326H, BWG208499H, BWG208223H, BWG208491H, BWG208541H, BWG208573H, BWG208304H, BWG208323H, BWG208345H, BWG208370H, BWG208672H, BWG208250H, BWG208270H, BWG208346H, BWG208389H, BWG208482H, BWG208494H, BWG208495H, BWG208497H, BWG208498H, BWG208521H, BWG208547H, BWG208396H, BWG208799H, BWG208224H, BWG208225H, BWG208258H, BWG208261H, BWG208272H, BWG208275H, BWG208276H, BWG208279H, BWG208328H, BWG208337H, BWG208343H, BWG208357H, BWG208360H, BWG208361H, BWG208416H, BWG208417H, BWG208422H, BWG208423H, BWG208462H, BWG208464H, BWG208465H, BWG208468H, BWG208469H, BWG208470H, BWG208471H, BWG208472H, BWG208581H, BWG208583H, BWG208584H, BWG208585H, BWG208586H, BWG208587H, BWG208588H, BWG208639H, BWG208647H, BWG208649H, BWG208660H, BWG208661H, BWG208663H, BWG208664H, BWG208668H, BWG208674H, BWG208770H, BWG208774H, BWG208775H, BWG208777H, BWG208778H, BWG208779H, BWG208780H, BWG208781H, BWG208421H, BWG208452H, BWG208486H, BWG208493H, BWG208504H, BWG208571H, BWG208614H, BWG208543H, BWG208549H, BWG208681H, BWG208544H, BWG208002H, BWG208212H, BWG208359H, BWG208373H, BWG208413H, BWG208447H, BWG208232H, BWG208252H, BWG208205H, BWG208386H, BWG208540H, BWG208575H, BWG208631H, BWG208769H, BWG208306H, BWG208768H, BWG208273H, BWG208689H, BWG208742H, BWG208798H, BWG208227H, BWG208796H, BWG208797H, BWG208475H, BWG208552H, BWG208365H, BWG208390H, BWG208350H, BWG208435H, BWG208562H, BWG208680H, BWG208691H, BWG208762H, BWG208208H, BWG208247H, BWG208300H, BWG208358H, BWG208397H, BWG208523H, BWG208525H, BWG208592H, BWG208599H, BWG208671H, BWG208682H, BWG208704H, BWG208707H, BWG208718H, BWG208428H, BWG208432H, BWG208648H, BWG208444H, BWG208559H, BWG208533H, BWG208644H, BWG208744H, BWG208603H, BWG208203H, BWG208260H, BWG208271H, BWG208384H, BWG208407H, BWG208489H, BWG208005H, BWG208694H, BWG208548H, BWG208650H, BWG208725H, BWG208253H, BWG208394H, BWG208446H, BWG208448H, BWG208454H, BWG208503H, BWG208579H, BWG208612H, BWG208723H, BWG208589H, BWG208748H, BWG208307H, BWG208202H, BWG208214H, BWG208283H, BWG208311H, BWG208314H, BWG208322H, BWG208352H, BWG208374H, BWG208496H, BWG208572H, BWG208594H, BWG208613H, BWG208629H, BWG208675H, BWG208727H, BWG208732H, BWG208737H, BWG208761H, BWG208756H, BWG208290H, BWG208297H, BWG208298H, BWG208342H, BWG208367H, BWG208393H, BWG208478H, BWG208616H, BWG208657H, BWG208703H, BWG208371H, BWG208210H, BWG208606H, BWG208715H, BWG208754H, BWG208353H, BWG208560H, BWG208209H, BWG208395H, BWG208240H, BWG208372H, BWG208431H, BWG208481H, BWG208551H, BWG208688H, BWG208517H, BWG208563H, BWG208404H, BWG208512H, BWG208266H, BWG208248H, BWG208665H, BWG208259H, BWG208449H, BWG208458H, BWG208511H, BWG208537H, BWG208564H, BWG208651H, BWG208710H, BWG208436H, BWG208455H, BWG208638H, BWG208235H, BWG208242H, BWG208318H, BWG208377H, BWG208415H, BWG208466H, BWG208467H, BWG208653H, BWG208246H, BWG208320H, BWG208535H, BWG208536H, BWG208626H, BWG208628H, BWG208632H, BWG208721H, BWG208793H, BWG208645H, BWG208408H, BWG208659H, BWG208501H, BWG208427H, BWG208627H, BWG208566H, BWG208595H, BWG208255H, BWG208643H, BWG208387H, BWG208233H, BWG208257H, BWG208375H, BWG208555H, BWG208726H, BWG208003H, BWG208329H, BWG208381H, BWG208383H, BWG208401H, BWG208556H, BWG208263H, BWG208302H, BWG208324H, BWG208341H, BWG208400H, BWG208696H, BWG208736H, BWG208751H, BWG208795H, BWG208568H, BWG208580H, BWG208254H, BWG208600H, BWG208348H, BWG208630H, BWG208633H, BWG208701H, BWG208461H, BWG208522H, BWG208711H, BWG208327H, BWG208743H, BWG208474H, BWG208593H, BWG208256H, BWG208268H, BWG208309H, BWG208319H, BWG208363H, BWG208364H, BWG208414H, BWG208463H, BWG208574H, BWG208611H, BWG208623H, BWG208642H, BWG208655H, BWG208666H, BWG208695H, BWG208755H, BWG208658H, BWG208379H, BWG208439H, BWG208534H, BWG208610H, BWG208617H, BWG208490H, BWG208457H, BWG208262H, BWG208382H, BWG208477H, BWG208554H, BWG208625H, BWG208391H, BWG208459H, BWG208529H, BWG208531H, BWG208226H, BWG208339H, BWG208604H, BWG208624H, BWG208699H, BWG208479H, BWG208697H, BWG208228H, BWG208418H, BWG208419H, BWG208450H, BWG208684H, BWG208294H, BWG208706H, BWG208285H, BWG208218H, BWG208378H, BWG208456H, BWG208569H, BWG208601H, BWG208618H, BWG208622H, BWG208683H, BWG208709H, BWG208747H, BWG208292H, BWG208295H, BWG208440H, BWG208558H, BWG208669H, BWG208679H, BWG208685H, BWG208687H, BWG208712H, BWG208713H, BWG208714H, BWG208719H, BWG208728H, BWG208765H, BWG208338H, BWG208546H, BWG208615H, BWG208487H; GTIN 00643169720428, Lot Serial Numbers: BWG606752S, BWG606481S, BWG606334S, BWG606796S, BWG606352S, BWG606515S, BWG606384S, BWG606530S, BWG606659S, BWG606661S, BWG606685S, BWG606508S, BWG606697S, BWG606689S, BWG606501S, BWG606355S, BWG606472S, BWG606512S, BWG606527S, BWG606535S, BWG606547S, BWG606558S, BWG606585S, BWG606588S, BWG606598S, BWG606691S, BWG606713S, BWG606732S, BWG606795S, BWG606741S, BWG606572S, BWG606345S, BWG606462S, BWG606390S, BWG606410S, BWG606421S, BWG606522S, BWG606531S, BWG606534S, BWG606589S, BWG606607S, BWG607320S, BWG606326S, BWG606347S, BWG606357S, BWG606409S, BWG606517S, BWG606519S, BWG606657S, BWG606513S, BWG606493S, BWG606363S, BWG606337S, BWG606690S, BWG606356S, BWG606411S, BWG606536S, BWG606537S, BWG606665S, BWG606596S, BWG606539S, BWG606580S, BWG606616S, BWG606358S, BWG606351S, BWG606348S, BWG606581S, BWG606584S, BWG606407S, BWG606757S, BWG606777S, BWG606794S, BWG606422S, BWG606502S, BWG606532S, BWG606615S, BWG606524S, BWG606538S, BWG606593S, BWG606672S, BWG606431S, BWG606468S, BWG606556S, BWG606586S, BWG606591S, BWG606595S, BWG606817S, BWG606629S, BWG606550S, BWG606381S, BWG606671S, BWG606336S, BWG606712S, BWG606544S, BWG606625S, BWG606751S, BWG606617S, BWG606801S, BWG606896S, BWG606571S, BWG606573S, BWG606745S, BWG606765S, BWG606774S, BWG606780S, BWG606798S, BWG606899S, BWG606553S, BWG606569S, BWG606343S, BWG606561S, BWG606557S, BWG606403S, BWG606555S, BWG606582S, BWG606749S, BWG606788S, BWG606420S, BWG606663S, BWG606701S, BWG606562S, BWG606563S, BWG606566S, BWG606567S, BWG606323S, BWG606330S, BWG606332S, BWG606339S, BWG606354S, BWG606360S, BWG606368S, BWG606369S, BWG606371S, BWG606526S, BWG606533S, BWG606546S, BWG606548S, BWG606549S, BWG606570S, BWG606574S, BWG606597S, BWG606600S, BWG606743S, BWG606748S, BWG606762S, BWG606764S, BWG606791S, BWG606523S, BWG606529S, BWG607296S, BWG607305S, BWG606623S, BWG606495S, BWG606498S, BWG606415S, BWG606327S, BWG606367S, BWG606692S, BWG606695S, BWG606399S, BWG606401S, BWG606406S, BWG606412S, BWG606413S, BWG606437S, BWG606554S, BWG606733S, BWG607421S, BWG606423S, BWG606424S, BWG606670S, BWG606677S, BWG606687S, BWG606693S, BWG606694S, BWG606699S, BWG606551S, BWG606329S, BWG606698S, BWG606325S, BWG606335S, BWG606426S, BWG606753S, BWG606362S, BWG607156S, BWG606380S, BWG606475S, BWG606487S, BWG606521S, BWG606577S, BWG606579S, BWG606746S, BWG606747S, BWG606790S, BWG606338S, BWG606425S, BWG606379S, BWG606417S, BWG606394S, BWG606395S, BWG606396S, BWG606397S, BWG606398S, BWG606477S, BWG606478S, BWG606480S, BWG606485S, BWG606489S, BWG606491S, BWG606714S, BWG606717S, BWG606721S, BWG606723S, BWG606724S, BWG606728S, BWG606612S, BWG606614S, BWG606619S, BWG606622S, BWG606630S, BWG606353S, BWG606387S, BWG606400S, BWG606414S, BWG606450S, BWG606453S, BWG606653S, BWG606675S, BWG606730S, BWG606758S, BWG606769S, BWG606775S, BWG606776S, BWG606779S, BWG606797S, BWG606800S, BWG606803S, BWG606804S, BWG606815S, BWG606832S, BWG606834S, BWG606853S, BWG606854S, BWG606859S, BWG606871S, BWG606876S, BWG606888S, BWG606889S, BWG606891S, BWG606892S, BWG606903S, BWG607009S, BWG607011S, BWG607186S, BWG607191S, BWG607192S, BWG607196S, BWG607203S, BWG607204S, BWG607276S, BWG607293S, BWG607313S, BWG607319S, BWG607323S, BWG607413S, BWG607461S, BWG607467S, BWG607473S, BWG607523S, BWG607525S, BWG607527S, BWG607531S, BWG607534S, BWG607581S, BWG607585S, BWG607593S, BWG607598S, BWG607619S, BWG607628S, BWG607632S, BWG607637S, BWG607651S, BWG606781S, BWG606783S, BWG606784S, BWG606785S, BWG606786S, BWG606497S, BWG606500S, BWG606664S, BWG606812S, BWG606823S, BWG606826S, BWG606839S, BWG606873S, BWG606877S, BWG606885S, BWG606893S, BWG606894S, BWG606902S, BWG607006S, BWG607071S, BWG607205S, BWG607208S, BWG607212S, BWG607280S, BWG607315S, BWG607404S, BWG607434S, BWG607436S, BWG607450S, BWG607455S, BWG607463S, BWG607520S, BWG607575S, BWG607580S, BWG607583S, BWG607586S, BWG607589S, BWG607591S, BWG607597S, BWG607599S, BWG607602S, BWG607610S, BWG607612S, BWG607613S, BWG607618S, BWG607634S, BWG607650S, BWG606408S, BWG606759S, BWG606760S, BWG606766S, BWG606767S, BWG606787S, BWG606802S, BWG606806S, BWG606808S, BWG606813S, BWG606819S, BWG606820S, BWG606821S, BWG606827S, BWG606836S, BWG606883S, BWG607012S, BWG607014S, BWG607195S, BWG607199S, BWG607214S, BWG607215S, BWG607278S, BWG607312S, BWG607385S, BWG607435S, BWG607441S, BWG607471S, BWG607472S, BWG607508S, BWG607519S, BWG607522S, BWG607528S, BWG607530S, BWG607532S, BWG607578S, BWG607588S, BWG607603S, BWG607604S, BWG607624S, BWG607635S, BWG606469S, BWG606668S, BWG606666S, BWG606754S, BWG606649S, BWG606709S, BWG606727S, BWG606476S, BWG606887S, BWG606383S, BWG606386S, BWG606389S, BWG606392S, BWG606393S, BWG606602S, BWG606603S, BWG606608S, BWG606609S, BWG606611S, BWG606620S, BWG606686S, BWG606688S, BWG606722S, BWG606725S, BWG606739S, BWG606740S, BWG607020S, BWG607023S, BWG607024S, BWG607046S, BWG607047S, BWG607048S, BWG607187S, BWG607188S, BWG607189S, BWG607209S, BWG607226S, BWG607227S, BWG607228S, BWG607229S, BWG607235S, BWG607277S, BWG607285S, BWG607292S, BWG607419S, BWG607495S, BWG607496S, BWG607501S, BWG607502S, BWG607509S, BWG607590S, BWG607630S, BWG607633S, BWG607638S, BWG607639S, BWG607734S, BWG607739S, BWG607742S, BWG607743S, BWG607896S, BWG607897S, BWG607898S, BWG607899S, BWG607900S, BWG607902S, BWG607912S, BWG607913S, BWG608016S, BWG608021S, BWG608024S, BWG608025S, BWG608026S, BWG608035S, BWG608036S, BWG608037S, BWG608038S, BWG608044S, BWG608046S, BWG608047S, BWG608048S, BWG606377S, BWG606456S, BWG606457S, BWG606463S, BWG606520S, BWG606621S, BWG606628S, BWG606631S, BWG606637S, BWG606640S, BWG606641S, BWG606642S, BWG606643S, BWG606645S, BWG606647S, BWG606648S, BWG606696S, BWG606700S, BWG606707S, BWG606708S, BWG606710S, BWG606715S, BWG606729S, BWG606731S, BWG607018S, BWG607019S, BWG607049S, BWG607050S, BWG607051S, BWG607052S, BWG607053S, BWG607157S, BWG607158S, BWG607160S, BWG607161S, BWG607220S, BWG607221S, BWG607283S, BWG607286S, BWG607287S, BWG607288S, BWG607291S, BWG607298S, BWG607299S, BWG607301S, BWG607302S, BWG607307S, BWG607386S, BWG607395S, BWG607396S, BWG607397S, BWG607398S, BWG607400S, BWG607446S, BWG607451S, BWG607462S, BWG607494S, BWG607498S, BWG607499S, BWG607500S, BWG607503S, BWG607504S, BWG607511S, BWG607513S, BWG607514S, BWG607515S, BWG607521S, BWG607608S, BWG607620S, BWG607621S, BWG607622S, BWG607625S, BWG607626S, BWG607627S, BWG607636S, BWG607642S, BWG607643S, BWG607649S, BWG607652S, BWG607653S, BWG607746S, BWG607747S, BWG607748S, BWG607749S, BWG607750S, BWG607751S, BWG607922S, BWG607923S, BWG607927S, BWG607928S, BWG607929S, BWG607930S, BWG607931S, BWG607932S, BWG607933S, BWG607934S, BWG607935S, BWG607936S, BWG607937S, BWG607938S, BWG607939S, BWG607940S, BWG607941S, BWG606321S, BWG606328S, BWG606331S, BWG606333S, BWG606378S, BWG606518S, BWG606373S, BWG606320S, BWG606404S, BWG606405S, BWG606416S, BWG606418S, BWG606419S, BWG606897S, BWG607402S, BWG607403S, BWG607418S, BWG606654S, BWG606900S,... |
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.