Recall archive / FDA device enforcement
ICD-VR DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; Implantable Cardioverter Defibrillators — FDA record Z-1800-2023
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 DVBC3D4 EVERA S DF4 GLOB, Model Number DVBC3D4; 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
- 5296 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1800-2023
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 00643169720442, Lot Serial Numbers: BWL206052H, BWL205879H, BWL206062H, BWL206106H, BWL206057H, BWL206066H, BWL206087H, BWL205882H, BWL206049H, BWL206050H, BWL206053H, BWL206055H, BWL206059H, BWL206069H, BWL206073H, BWL206074H, BWL206078H, BWL206079H, BWL206081H, BWL206082H, BWL206083H, BWL206084H, BWL206101H, BWL206104H, BWL206110H, BWL206112H, BWL206116H, BWL206118H, BWL206120H, BWL206122H, BWL206123H, BWL206126H, BWL206127H, BWL206068H, BWL206071H, BWL206092H, BWL206093H, BWL206094H, BWL206109H, BWL206117H, BWL206119H, BWL206097H, BWL205878H, BWL206098H, BWL206063H, BWL206114H, BWL206108H, BWL206048H, BWL206064H, BWL206058H, BWL206086H, BWL206099H, BWL206076H, BWL206103H, BWL206107H, BWL206124H, BWL206125H, BWL206105H, BWL206051H, BWL206054H; GTIN 00643169720459, Lot Serial Numbers: BWL606762S, BWL606799S, BWL609508S, BWL606741S, BWL607597S, BWL607510S, BWL607234S, BWL606748S, BWL607162S, BWL607513S, BWL607947S, BWL606791S, BWL607876S, BWL606995S, BWL607071S, BWL606857S, BWL606752S, BWL607088S, BWL606806S, BWL606900S, BWL606908S, BWL606738S, BWL606758S, BWL606759S, BWL607084S, BWL607199S, BWL607220S, BWL607277S, BWL607512S, BWL607519S, BWL607558S, BWL607571S, BWL607805S, BWL607806S, BWL609503S, BWL609505S, BWL609506S, BWL606452S, BWL606742S, BWL606743S, BWL606751S, BWL606757S, BWL606766S, BWL606767S, BWL606805S, BWL606840S, BWL606899S, BWL606942S, BWL607001S, BWL607013S, BWL607074S, BWL607215S, BWL607423S, BWL607542S, BWL607590S, BWL607593S, BWL607594S, BWL607613S, BWL607716S, BWL607910S, BWL608035S, BWL606781S, BWL606807S, BWL606837S, BWL606838S, BWL607609S, BWL606948S, BWL607556S, BWL607569S, BWL607581S, BWL607587S, BWL607721S, BWL607032S, BWL607034S, BWL607560S, BWL607610S, BWL607657S, BWL607902S, BWL609738S, BWL606872S, BWL607028S, BWL607030S, BWL607508S, BWL607509S, BWL607540S, BWL607635S, BWL607638S, BWL607705S, BWL607911S, BWL607958S, BWL607280S, BWL607666S, BWL607302S, BWL607961S, BWL607035S, BWL607036S, BWL607956S, BWL606746S, BWL606754S, BWL606765S, BWL607075S, BWL607073S, BWL607192S, BWL607194S, BWL607196S, BWL607536S, BWL607568S, BWL607573S, BWL607608S, BWL607630S, BWL607631S, BWL607884S, BWL607894S, BWL607900S, BWL607901S, BWL606749S, BWL606750S, BWL607043S, BWL607044S, BWL607505S, BWL607506S, BWL607595S, BWL607596S, BWL607727S, BWL607730S, BWL607010S, BWL607011S, BWL607223S, BWL607945S, BWL607269S, BWL608004S, BWL607255S, BWL606725S, BWL606726S, BWL606727S, BWL606776S, BWL606798S, BWL607959S, BWL606941S, BWL607038S, BWL607306S, BWL607903S, BWL607086S, BWL607555S, BWL607557S, BWL608138S, BWL607507S, BWL607012S, BWL607298S, BWL606718S, BWL606734S, BWL607219S, BWL606735S, BWL608113S, BWL607469S, BWL607224S, BWL606760S, BWL606761S, BWL606847S, BWL606851S, BWL606853S, BWL606876S, BWL607543S, BWL608031S, BWL607530S, BWL607531S, BWL606901S, BWL607305S, BWL607714S, BWL607718S, BWL606846S, BWL607588S, BWL606994S, BWL606848S, BWL606756S, BWL607029S, BWL607193S, BWL607951S, BWL607272S, BWL606717S, BWL609633S, BWL607500S, BWL607037S, BWL607867S, BWL607885S, BWL606728S, BWL609911S, BWL606768S, BWL606769S, BWL606789S, BWL606790S, BWL607316S, BWL607222S, BWL607575S, BWL607578S, BWL607580S, BWL607582S, BWL607586S, BWL607591S, BWL607592S, BWL607599S, BWL607601S, BWL607603S, BWL607606S, BWL607607S, BWL607618S, BWL607619S, BWL607249S, BWL607517S, BWL607662S, BWL608028S, BWL607221S, BWL607371S, BWL609557S, BWL607047S, BWL607503S, BWL607518S, BWL607798S, BWL608732S, BWL608754S, BWL609502S, BWL609658S, BWL606733S, BWL607007S, BWL606835S, BWL606810S, BWL607541S, BWL606935S, BWL606936S, BWL606987S, BWL606988S, BWL606989S, BWL606990S, BWL606993S, BWL607585S, BWL607616S, BWL607624S, BWL607649S, BWL607688S, BWL607690S, BWL608194S, BWL608251S, BWL608321S, BWL608322S, BWL608323S, BWL608324S, BWL608326S, BWL608389S, BWL608398S, BWL608400S, BWL608976S, BWL608984S, BWL608990S, BWL609019S, BWL609179S, BWL609183S, BWL607745S, BWL607754S, BWL608116S, BWL608140S, BWL608143S, BWL606755S, BWL606930S, BWL607002S, BWL607022S, BWL607366S, BWL607561S, BWL607576S, BWL607611S, BWL607614S, BWL607620S, BWL607621S, BWL607645S, BWL607650S, BWL608378S, BWL608382S, BWL608384S, BWL608391S, BWL608866S, BWL608918S, BWL608921S, BWL608963S, BWL608966S, BWL608970S, BWL608978S, BWL608994S, BWL609020S, BWL609162S, BWL609164S, BWL609171S, BWL609172S, BWL609180S, BWL606719S, BWL606934S, BWL607021S, BWL607390S, BWL608874S, BWL607516S, BWL607897S, BWL606944S, BWL607040S, BWL607640S, BWL607653S, BWL606817S, BWL606819S, BWL606820S, BWL606822S, BWL606730S, BWL606824S, BWL606829S, BWL606833S, BWL606836S, BWL606912S, BWL606924S, BWL606925S, BWL606926S, BWL606928S, BWL607077S, BWL607078S, BWL607080S, BWL607092S, BWL607093S, BWL607094S, BWL607122S, BWL607123S, BWL607124S, BWL607133S, BWL607134S, BWL607143S, BWL607145S, BWL607146S, BWL607148S, BWL607149S, BWL607169S, BWL607171S, BWL607172S, BWL607186S, BWL607187S, BWL607189S, BWL607200S, BWL607203S, BWL607204S, BWL607370S, BWL607389S, BWL607391S, BWL607395S, BWL607396S, BWL607397S, BWL607399S, BWL607400S, BWL607407S, BWL607408S, BWL607409S, BWL607410S, BWL607411S, BWL607412S, BWL607413S, BWL607414S, BWL607415S, BWL607416S, BWL607417S, BWL607969S, BWL607979S, BWL607986S, BWL608087S, BWL608088S, BWL608089S, BWL608090S, BWL608091S, BWL608092S, BWL608099S, BWL608136S, BWL608137S, BWL608139S, BWL608144S, BWL608146S, BWL608147S, BWL608148S, BWL608151S, BWL608152S, BWL608154S, BWL608155S, BWL608156S, BWL608347S, BWL608349S, BWL608366S, BWL608367S, BWL608368S, BWL608385S, BWL608386S, BWL608387S, BWL608395S, BWL608397S, BWL608401S, BWL608405S, BWL608407S, BWL608408S, BWL608410S, BWL608466S, BWL608467S, BWL608478S, BWL608479S, BWL608480S, BWL608487S, BWL608492S, BWL608516S, BWL608517S, BWL608518S, BWL608521S, BWL608525S, BWL608584S, BWL608586S, BWL608588S, BWL608590S, BWL608635S, BWL608637S, BWL608638S, BWL608715S, BWL608717S, BWL608718S, BWL608719S, BWL608720S, BWL608721S, BWL608724S, BWL608727S, BWL608739S, BWL608740S, BWL608746S, BWL608747S, BWL608756S, BWL608757S, BWL608764S, BWL608806S, BWL608807S, BWL608826S, BWL608827S, BWL608828S, BWL608829S, BWL608830S, BWL608868S, BWL608869S, BWL608870S, BWL608871S, BWL608876S, BWL608937S, BWL608938S, BWL608939S, BWL608973S, BWL608974S, BWL608975S, BWL609027S, BWL609028S, BWL609029S, BWL609030S, BWL609031S, BWL609168S, BWL609169S, BWL609170S, BWL609173S, BWL609176S, BWL609189S, BWL609190S, BWL609333S, BWL609334S, BWL609335S, BWL609336S, BWL609337S, BWL609338S, BWL609340S, BWL609341S, BWL609342S, BWL609428S, BWL609429S, BWL609430S, BWL609431S, BWL609432S, BWL609519S, BWL609520S, BWL609521S, BWL609522S, BWL609523S, BWL609622S, BWL609623S, BWL609639S, BWL609640S, BWL609641S, BWL609642S, BWL609645S, BWL609646S, BWL609647S, BWL609648S, BWL609652S, BWL609653S, BWL609654S, BWL609655S, BWL609656S, BWL609657S, BWL609659S, BWL609669S, BWL609670S, BWL609671S, BWL609672S, BWL609729S, BWL609730S, BWL609732S, BWL609733S, BWL609734S, BWL609735S, BWL609755S, BWL609756S, BWL609757S, BWL609761S, BWL609764S, BWL609766S, BWL609772S, BWL609777S, BWL609778S, BWL609786S, BWL609789S, BWL609797S, BWL609798S, BWL609799S, BWL609800S, BWL609801S, BWL609802S, BWL609803S, BWL609804S, BWL609805S, BWL609806S, BWL609807S, BWL609808S, BWL609887S, BWL609888S, BWL609889S, BWL609890S, BWL609891S, BWL609892S, BWL609893S, BWL606863S, BWL606967S, BWL606971S, BWL606965S, BWL608485S, BWL606451S, BWL606793S, BWL606800S, BWL606813S, BWL606825S, BWL606826S, BWL606827S, BWL606828S, BWL606830S, BWL606831S, BWL606832S, BWL606869S, BWL606880S, BWL606881S, BWL606882S, BWL606884S, BWL606887S, BWL606888S, BWL606889S, BWL606890S, BWL606891S, BWL606892S, BWL606893S, BWL606894S, BWL606895S, BWL606914S, BWL606915S, BWL606918S, BWL606919S, BWL606943S, BWL606945S, BWL606946S, BWL606966S, BWL606991S, BWL607015S, BWL607081S, BWL607082S, BWL607085S, BWL607087S, BWL607089S, BWL607090S, BWL607151S, BWL607153S, BWL607173S, BWL607176S, BWL607198S, BWL607201S, BWL607202S, BWL607206S, BWL607207S, BWL607208S, BWL607209S, BWL607283S, BWL607284S, BWL607285S, BWL607309S, BWL607312S, BWL607313S, BWL607315S, BWL607317S, BWL607328S, BWL607329S, BWL607330S, BWL607331S, BWL607372S, BWL607373S, BWL607376S, BWL607749S, BWL607751S, BWL607764S, BWL607779S, BWL607824S, BWL607863S, BWL607946S, BWL607950S, BWL607970S, BWL607989S, BWL607996S, BWL608003S, BWL608008S, BWL608014S, BWL608020S, BWL608104S, BWL608106S, BWL608107S, BWL608112S, BWL608121S, BWL608205S, BWL608206S, BWL608207S, BWL608208S, BWL608209S, BWL608211S, BWL608212S, BWL608213S, BWL608214S, BWL608215S, BWL608228S, BWL608229S, BWL608232S, BWL608233S, BWL608253S, BWL608254S, BWL608350S, BWL608351S, BWL608352S, BWL608355S, BWL608356S, BWL608357S, BWL608358S, BWL608359S, BWL608360S, BWL608361S, BWL608372S, BWL608373S, BWL608374S, BWL608375S, BWL608376S, BWL608377S, BWL608379S, BWL608380S, BWL608381S, BWL608383S, BWL608464S, BWL608465S, BWL608497S, BWL608499S, BWL608502S, BWL608503S, BWL608505S, BWL608506S, BWL608591S, BWL608592S, BWL608696S, BWL608698S, BWL608700S, BWL608701S, BWL608703S, BWL608706S, BWL608708S, BWL608709S, BWL608710S, BWL608728S, BWL608729S, BWL608796S, BWL608797S, BWL608798S, BWL608799S, BWL608800S, BWL608801S, BWL608802S, BWL608809S, BWL608810S, BWL608883S, BWL608884S, BWL608885S, BWL608886S, BWL608887S, BWL608888S, BWL608889S, BWL608969S, BWL608977S, BWL608979S, BWL608980S, BWL608983S, BWL608985S, BWL608986S, BWL608987S, BWL608989S, BWL608991S, BWL608992S, BWL608993S, BWL608996S, BWL609004S, BWL609018S, BWL609035S, BWL609036S, BWL609037S, BWL609038S, BWL609241S, BWL609242S, BWL609243S, BWL609244S, BWL609245S, BWL609247S, BWL609248S, BWL609319S, BWL609320S, BWL609321S, BWL609322S, BWL609324S, BWL609330S, BWL609331S, BWL609343S, BWL609344S, BWL609345S, BWL609346S, BWL609347S, BWL609348S, BWL609433S, BWL609439S, BWL609440S, BWL609441S, BWL609443S, BWL609444S, BWL609461S, BWL609462S, BWL609463S, BWL609538S, BWL609553S, BWL609559S, BWL609560S, BWL609561S, BWL609562S, BWL609563S, BWL609564S, BWL609565S, BWL609566S, BWL609567S, BWL609568S, BWL609569S, BWL609570S, BWL609571S, BWL609572S, BWL609573S, BWL609574S, BWL609575S, BWL609576S, BWL609577S, BWL609578S, BWL609595S, BWL609596S, BWL609597S, BWL609598S, BWL609666S, BWL607239S, BWL607497S, BWL607702S, BWL606861S, BWL608498S, BWL606721S, BWL607695S, BWL608388S, BWL606731S, BWL606732S, BWL606855S, BWL606862S, BWL607281S, BWL606722S, BWL606770S, BWL606973S, BWL606996S, BWL606997S, BWL606998S, BWL606999S, BWL607014S, BWL607016S, BWL607017S, BWL607018S, BWL607019S, BWL607252S, BWL607254S, BWL607672S, BWL607676S, BWL607680S, BWL607682S, BWL607687S, BWL607689S, BWL607691S, BWL607717S, BWL607866S, BWL607039S, BWL607802S, BWL607803S, BWL606720S, BWL606870S, BWL606871S, BWL607905S, BWL606453S, BWL606969S, BWL608370S, BWL608486S, BWL608504S, BWL606951S, BWL606962S, BWL607725S, BWL607944S, BWL608122S, BWL606961S, BWL607726S, BWL606771S, BWL606772S, BWL606774S, BWL606777S, BWL606976S, BWL606978S, BWL606979S, BWL606981S, BWL606982S, BWL606983S, BWL606940S, BWL607788S, BWL606909S, BWL606910S, BWL606913S, BWL606739S, BWL606744S, BWL606867S, BWL606868S, BWL606778S, BWL606788S, BWL606792S, BWL606984S, BWL606985S, BWL606986S, BWL607375S, BWL607421S, BWL607422S, BWL607869S, BWL607878S, BWL607890S, BWL607893S, BWL608168S, BWL608169S, BWL608170S, BWL608171S, BWL608172S, BWL608173S, BWL606977S, BWL607031S, BWL607063S, BWL607070S, BWL607229S, BWL607230S, BWL607233S, BWL607236S, BWL607238S, BWL607240S, BWL607243S, BWL607245S, BWL607246S, BWL607247S, BWL607264S, BWL607265S, BWL607266S, BWL607427S, BWL607429S, BWL607430S, BWL607435S, BWL607436S, BWL607437S, BWL607447S, BWL607448S, BWL607454S, BWL607538S, BWL607544S, BWL607574S, BWL607627S, BWL607825S, BWL607826S, BWL607827S, BWL607828S, BWL607829S, BWL607830S, BWL607831S, BWL607833S, BWL607834S, BWL607835S, BWL606736S, BWL606737S, BWL606740S, BWL607041S, BWL607042S, BWL607083S, BWL607261S, BWL606834S, BWL607251S, BWL606803S, BWL607046S, BWL607267S, BWL607268S, BWL607270S, BWL607271S, BWL607274S, BWL607286S, BWL607287S, BWL607288S, BWL607289S, BWL607290S, BWL607291S,... |
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.