Recall archive / FDA device enforcement
CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; Implantable Cardioverter Defibrillators — FDA record Z-1766-2023
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
- CRTD DTMB2D4 AMPLIA MRI OUS DF4, Model Number DTMB2D4; 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
- 8575 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1766-2023
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 00643169720725, Lot Serial Numbers: RPK603310S, RPK606030S, RPK607323S, RPK606692S, RPK605552S, RPK604274S, RPK607156S, RPK607510S, RPK606721S, RPK606379S, RPK606753S, RPK603895S, RPK607997S, RPK608001S, RPK608115S, RPK602608S, RPK602842S, RPK602915S, RPK603155S, RPK603438S, RPK603475S, RPK604209S, RPK604230S, RPK604885S, RPK605001S, RPK605994S, RPK606046S, RPK606664S, RPK607134S, RPK608665S, RPK604002S, RPK604373S, RPK605499S, RPK605680S, RPK603963S, RPK607543S, RPK607544S, RPK607943S, RPK608088S, RPK608203S, RPK607149S, RPK607416S, RPK607418S, RPK607615S, RPK608212S, RPK608297S, RPK608298S, RPK609062S, RPK604646S, RPK605555S, RPK605685S, RPK606797S, RPK604171S, RPK605262S, RPK605291S, RPK605292S, RPK606475S, RPK607086S, RPK603372S, RPK603375S, RPK603380S, RPK603962S, RPK604174S, RPK604351S, RPK604536S, RPK604651S, RPK604654S, RPK604869S, RPK604972S, RPK604973S, RPK605109S, RPK605214S, RPK605233S, RPK605272S, RPK606024S, RPK606053S, RPK606141S, RPK606473S, RPK606792S, RPK606817S, RPK606853S, RPK607088S, RPK607422S, RPK607441S, RPK607442S, RPK607443S, RPK607620S, RPK607647S, RPK607857S, RPK607865S, RPK607972S, RPK608102S, RPK608939S, RPK604642S, RPK604644S, RPK604989S, RPK607684S, RPK608101S, RPK608890S, RPK603423S, RPK603908S, RPK604177S, RPK604228S, RPK604660S, RPK604981S, RPK605848S, RPK606143S, RPK606525S, RPK606535S, RPK607423S, RPK607911S, RPK607917S, RPK607918S, RPK604191S, RPK606048S, RPK606472S, RPK606793S, RPK606813S, RPK606816S, RPK607922S, RPK604227S, RPK604353S, RPK604630S, RPK605297S, RPK606819S, RPK606880S, RPK607479S, RPK604631S, RPK604649S, RPK606045S, RPK606047S, RPK604183S, RPK607541S, RPK605294S, RPK605491S, RPK607420S, RPK607424S, RPK607916S, RPK604169S, RPK607617S, RPK604354S, RPK605972S, RPK607864S, RPK604337S, RPK606799S, RPK607862S, RPK607970S, RPK605255S, RPK606479S, RPK606795S, RPK603498S, RPK607111S, RPK605251S, RPK602530S, RPK602763S, RPK604901S, RPK605486S, RPK606302S, RPK606871S, RPK606924S, RPK607005S, RPK607012S, RPK602647S, RPK603874S, RPK604083S, RPK604250S, RPK604637S, RPK604843S, RPK605472S, RPK605501S, RPK605944S, RPK608697S, RPK608716S, RPK602684S, RPK607155S, RPK608751S, RPK603603S, RPK603793S, RPK604657S, RPK604914S, RPK606445S, RPK608369S, RPK603127S, RPK603736S, RPK603744S, RPK604254S, RPK604761S, RPK604816S, RPK605328S, RPK606467S, RPK607777S, RPK608737S, RPK606595S, RPK607324S, RPK602648S, RPK603632S, RPK608510S, RPK602495S, RPK602759S, RPK603124S, RPK607846S, RPK607699S, RPK602811S, RPK602613S, RPK608087S, RPK603103S, RPK605235S, RPK606577S, RPK602662S, RPK603185S, RPK605397S, RPK605466S, RPK602556S, RPK602590S, RPK603507S, RPK604255S, RPK604426S, RPK605441S, RPK605698S, RPK607293S, RPK608446S, RPK602502S, RPK605307S, RPK605334S, RPK605467S, RPK605469S, RPK606398S, RPK607835S, RPK608429S, RPK605036S, RPK605290S, RPK605487S, RPK605723S, RPK606252S, RPK606490S, RPK606668S, RPK606791S, RPK607004S, RPK607331S, RPK607820S, RPK607976S, RPK608217S, RPK608382S, RPK608513S, RPK608953S, RPK608976S, RPK603433S, RPK606865S, RPK602561S, RPK602883S, RPK606212S, RPK606603S, RPK607653S, RPK608883S, RPK608275S, RPK603636S, RPK603657S, RPK605077S, RPK606947S, RPK608365S, RPK608725S, RPK605327S, RPK606596S, RPK607188S, RPK604573S, RPK606513S, RPK606580S, RPK606604S, RPK607603S, RPK607608S, RPK607686S, RPK602588S, RPK608270S, RPK602851S, RPK605459S, RPK607073S, RPK608450S, RPK608545S, RPK606412S, RPK606978S, RPK607745S, RPK608735S, RPK602595S, RPK602641S, RPK602816S, RPK603264S, RPK603656S, RPK603735S, RPK603883S, RPK604088S, RPK604801S, RPK605570S, RPK607279S, RPK607520S, RPK608016S, RPK608517S, RPK608794S, RPK608835S, RPK604800S, RPK604822S, RPK604950S, RPK605192S, RPK605573S, RPK605761S, RPK606681S, RPK607405S, RPK607725S, RPK607770S, RPK604622S, RPK602591S, RPK603086S, RPK603972S, RPK604363S, RPK605579S, RPK606589S, RPK607161S, RPK606858S, RPK608520S, RPK608804S, RPK608834S, RPK603263S, RPK605210S, RPK608696S, RPK602600S, RPK602712S, RPK603258S, RPK605971S, RPK606930S, RPK608740S, RPK608800S, RPK605935S, RPK606142S, RPK606362S, RPK606399S, RPK608469S, RPK608541S, RPK608574S, RPK608850S, RPK602989S, RPK603041S, RPK603134S, RPK603252S, RPK603544S, RPK603547S, RPK604006S, RPK604136S, RPK604225S, RPK604460S, RPK604578S, RPK604617S, RPK604688S, RPK604734S, RPK604958S, RPK605028S, RPK605076S, RPK605115S, RPK605304S, RPK605370S, RPK605710S, RPK605993S, RPK606189S, RPK606254S, RPK606860S, RPK606984S, RPK607015S, RPK607594S, RPK607736S, RPK607839S, RPK607991S, RPK608072S, RPK608532S, RPK608824S, RPK608853S, RPK608880S, RPK608930S, RPK608958S, RPK603489S, RPK603617S, RPK604434S, RPK605075S, RPK605497S, RPK605904S, RPK606384S, RPK608170S, RPK606568S, RPK608516S, RPK604858S, RPK608882S, RPK608849S, RPK606388S, RPK608172S, RPK608868S, RPK606495S, RPK606723S, RPK607302S, RPK607816S, RPK608425S, RPK602670S, RPK605539S, RPK603545S, RPK605470S, RPK605908S, RPK606794S, RPK607082S, RPK607162S, RPK608391S, RPK605703S, RPK606222S, RPK607283S, RPK607476S, RPK604748S, RPK605117S, RPK605384S, RPK605412S, RPK606830S, RPK607546S, RPK607769S, RPK607169S, RPK602673S, RPK604147S, RPK604604S, RPK604847S, RPK606727S, RPK608493S, RPK603900S, RPK605000S, RPK608171S, RPK608093S, RPK602603S, RPK603609S, RPK606187S, RPK607074S, RPK607337S, RPK606843S, RPK608734S, RPK608959S, RPK604294S, RPK606566S, RPK608747S, RPK606310S, RPK606606S, RPK608840S, RPK608865S, RPK604301S, RPK604556S, RPK606111S, RPK604405S, RPK603655S, RPK608286S, RPK602714S, RPK605369S, RPK606381S, RPK606534S, RPK607832S, RPK608459S, RPK608743S, RPK602667S, RPK603530S, RPK606377S, RPK606938S, RPK607700S, RPK607845S, RPK608809S, RPK608567S, RPK606214S, RPK608485S, RPK608581S, RPK603235S, RPK605007S, RPK606803S, RPK605367S, RPK606488S, RPK606682S, RPK607572S, RPK608851S, RPK608885S, RPK605399S, RPK606068S, RPK605348S, RPK605658S, RPK605968S, RPK606348S, RPK607833S, RPK608629S, RPK604424S, RPK602581S, RPK605219S, RPK605415S, RPK606371S, RPK606487S, RPK606550S, RPK606715S, RPK607206S, RPK607351S, RPK607989S, RPK602808S, RPK602810S, RPK603546S, RPK604415S, RPK604459S, RPK604702S, RPK605332S, RPK605516S, RPK606273S, RPK606414S, RPK606579S, RPK606726S, RPK606855S, RPK606884S, RPK607641S, RPK607828S, RPK608419S, RPK608452S, RPK608837S, RPK603771S, RPK603801S, RPK604087S, RPK604359S, RPK604413S, RPK604707S, RPK605411S, RPK606349S, RPK602826S, RPK602871S, RPK602564S, RPK603490S, RPK603746S, RPK603823S, RPK608538S, RPK603454S, RPK603602S, RPK603670S, RPK606539S, RPK608463S, RPK608854S, RPK603192S, RPK603430S, RPK605122S, RPK606185S, RPK608091S, RPK608161S, RPK605025S, RPK606969S, RPK608857S, RPK603761S, RPK605022S, RPK603486S, RPK604500S, RPK606836S, RPK607326S, RPK603591S, RPK603519S, RPK603762S, RPK603812S, RPK604334S, RPK604412S, RPK604441S, RPK605031S, RPK605230S, RPK606069S, RPK603402S, RPK603871S, RPK605066S, RPK606663S, RPK603637S, RPK604687S, RPK608920S, RPK603510S, RPK603524S, RPK603840S, RPK604504S, RPK605970S, RPK606999S, RPK607192S, RPK608494S, RPK603653S, RPK607166S, RPK608076S, RPK602623S, RPK605211S, RPK608801S, RPK603126S, RPK603836S, RPK604273S, RPK605679S, RPK605913S, RPK608874S, RPK603515S, RPK603882S, RPK604870S, RPK606318S, RPK607407S, RPK608546S, RPK608864S, RPK608972S, RPK603683S, RPK608757S, RPK608351S, RPK602594S, RPK606404S, RPK606699S, RPK609018S, RPK603063S, RPK603726S, RPK603901S, RPK603905S, RPK604711S, RPK606608S, RPK606647S, RPK606771S, RPK606886S, RPK606946S, RPK607342S, RPK607909S, RPK608375S, RPK608519S, RPK608644S, RPK608765S, RPK608841S, RPK603210S, RPK603822S, RPK605034S, RPK608568S, RPK609012S, RPK602881S, RPK603107S, RPK605337S, RPK605341S, RPK606179S, RPK606502S, RPK606686S, RPK602537S, RPK608449S, RPK606950S, RPK607715S, RPK607811S, RPK607827S, RPK607863S, RPK608271S, RPK608277S, RPK605154S, RPK605763S, RPK606402S, RPK607059S, RPK607765S, RPK608027S, RPK602977S, RPK603814S, RPK603819S, RPK604887S, RPK605378S, RPK606018S, RPK606862S, RPK608357S, RPK608986S, RPK603592S, RPK604309S, RPK604668S, RPK605194S, RPK605359S, RPK607554S, RPK607860S, RPK608294S, RPK603562S, RPK605207S, RPK606071S, RPK606168S, RPK606876S, RPK608049S, RPK608952S, RPK609054S, RPK607734S, RPK609040S, RPK604745S, RPK605323S, RPK605704S, RPK606043S, RPK606223S, RPK606347S, RPK606411S, RPK606588S, RPK606637S, RPK606759S, RPK607076S, RPK607352S, RPK607869S, RPK608089S, RPK608092S, RPK608712S, RPK608981S, RPK605335S, RPK605498S, RPK606920S, RPK607089S, RPK607393S, RPK607622S, RPK608187S, RPK606952S, RPK607264S, RPK602217S, RPK602567S, RPK602752S, RPK602831S, RPK603845S, RPK604462S, RPK604615S, RPK608424S, RPK602569S, RPK604814S, RPK606941S, RPK604605S, RPK604606S, RPK604609S, RPK604614S, RPK606311S, RPK606314S, RPK603528S, RPK603788S, RPK603839S, RPK605339S, RPK606198S, RPK606707S, RPK607953S, RPK608674S, RPK608761S, RPK608785S, RPK602566S, RPK606877S, RPK607019S, RPK602894S, RPK603236S, RPK603815S, RPK604245S, RPK604672S, RPK604867S, RPK606116S, RPK606255S, RPK606636S, RPK606942S, RPK607274S, RPK607806S, RPK608105S, RPK608113S, RPK608596S, RPK603278S, RPK604042S, RPK603393S, RPK604861S, RPK606600S, RPK607148S, RPK606498S, RPK604235S, RPK602559S, RPK603410S, RPK608326S, RPK603060S, RPK603179S, RPK603326S, RPK607189S, RPK608970S, RPK602580S, RPK603045S, RPK602797S, RPK603049S, RPK603062S, RPK603080S, RPK603081S, RPK603580S, RPK603581S, RPK603816S, RPK603854S, RPK603856S, RPK604150S, RPK604151S, RPK602998S, RPK602480S, RPK602626S, RPK602633S, RPK604263S, RPK604364S, RPK604725S, RPK605288S, RPK605574S, RPK605715S, RPK602560S, RPK602563S, RPK602570S, RPK602574S, RPK602622S, RPK602624S, RPK602628S, RPK603135S, RPK603142S, RPK603319S, RPK603329S, RPK603331S, RPK603449S, RPK604451S, RPK604547S, RPK604552S, RPK605032S, RPK605118S, RPK605120S, RPK605840S, RPK606005S, RPK606376S, RPK606530S, RPK607078S, RPK607350S, RPK607354S, RPK608870S, RPK604319S, RPK607376S, RPK602523S, RPK602524S, RPK602525S, RPK602527S, RPK602528S, RPK602650S, RPK602711S, RPK602727S, RPK603022S, RPK603024S, RPK603054S, RPK603280S, RPK603282S, RPK603289S, RPK603292S, RPK603293S, RPK603615S, RPK603630S, RPK604361S, RPK604532S, RPK604533S, RPK604534S, RPK606307S, RPK606308S, RPK607627S, RPK607628S, RPK602551S, RPK602653S, RPK603138S, RPK603140S, RPK603158S, RPK608571S, RPK608805S, RPK609079S, RPK603120S, RPK608261S, RPK602511S, RPK603309S, RPK604716S, RPK602836S, RPK602882S, RPK603245S, RPK604142S, RPK604806S, RPK604809S, RPK604810S, RPK605042S, RPK605237S, RPK605947S, RPK606230S, RPK606341S, RPK606554S, RPK606555S, RPK606823S, RPK608547S, RPK603016S, RPK604432S, RPK605788S, RPK602216S, RPK602625S, RPK604093S, RPK604095S, RPK604135S, RPK604720S, RPK604724S, RPK604781S, RPK608464S, RPK602793S, RPK603035S, RPK603421S, RPK603847S, RPK604206S, RPK602499S, RPK603014S, RPK603125S, RPK603561S, RPK603792S, RPK603967S, RPK605360S, RPK603422S, RPK602536S, RPK607294S, RPK606537S, RPK606831S, RPK607041S, RPK607750S, RPK608079S, RPK608080S, RPK608328S, RPK609077S, RPK606309S, RPK606044S, RPK604751S, RPK605143S, RPK605319S, RPK608884S, RPK605673S, RPK602986S, RPK604519S, RPK604796S, RPK606138S, RPK606509S, RPK607812S, RPK608607S, RPK603455S, RPK603564S, RPK603891S, RPK604086S, RPK604238S, RPK608378S, RPK608989S, RPK605946S, RPK602546S, RPK604159S, RPK602935S, RPK608573S, RPK605116S, RPK605563S, RPK602640S, RPK603699S, RPK604802S, RPK603048S, RPK606641S, RPK602645S, RPK602850S, RPK602852S, RPK603023S, RPK603055S, RPK603057S, RPK603159S, RPK603169S, RPK603170S, RPK603596S, RPK603673S, RPK603674S, RPK604275S, RPK604419S, RPK604420S, RPK604666S, RPK604667S, RPK604689S, RPK604790S, RPK604795S, RPK604980S, RPK604982S, RPK604983S, RPK605114S, RPK605127S, RPK605128S, RPK605130S, RPK605136S, RPK605137S, RPK605244S, RPK605270S, RPK605277S, RPK605281S, RPK605285S, RPK605286S, RPK605355S, RPK605356S, RPK605363S, RPK605364S, RPK605436S, RPK605438S, RPK605471S, RPK605592S, RPK605595S, RPK605734S, RPK605750S, RPK605751S, RPK605756S, RPK605910S, RPK605916S, RPK605917S, RPK605951S, RPK605954S, RPK605955S, RPK605965S, RPK605966S, RPK605984S, RPK605985S, RPK605986S, RPK606140S, RPK6... |
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.