Recall archive / FDA device enforcement
CRTD DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; Implantable Cardioverter Defibrillators — FDA record Z-1760-2023
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 DTMA2QQ CLARIA MRI QUAD OUS DF4, Model Number DTMA2QQ; 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
- 23223 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1760-2023
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 00643169720640, Lot Serial Numbers: RPB618471S, RPB621777S, RPB619798S, RPB622872S, RPB620883S, RPB621725S, RPB612828S, RPB605719S, RPB615701S, RPB605409S, RPB609214S, RPB619400S, RPB611888S, RPB603955S, RPB617094S, RPB610684S, RPB603737S, RPB603739S, RPB603852S, RPB603887S, RPB603889S, RPB603892S, RPB604013S, RPB604131S, RPB604133S, RPB604139S, RPB604469S, RPB604482S, RPB604483S, RPB604484S, RPB604496S, RPB604508S, RPB604545S, RPB604692S, RPB604694S, RPB604731S, RPB605760S, RPB605763S, RPB605930S, RPB605982S, RPB606024S, RPB606084S, RPB606117S, RPB606124S, RPB606125S, RPB606136S, RPB606189S, RPB606190S, RPB606192S, RPB606492S, RPB606657S, RPB606773S, RPB606838S, RPB607008S, RPB607012S, RPB607049S, RPB607332S, RPB607709S, RPB607752S, RPB607793S, RPB607820S, RPB607825S, RPB607893S, RPB607897S, RPB607920S, RPB608192S, RPB608216S, RPB608222S, RPB608237S, RPB608293S, RPB608313S, RPB608351S, RPB608378S, RPB608498S, RPB608607S, RPB608621S, RPB608652S, RPB608696S, RPB608839S, RPB608867S, RPB609639S, RPB609652S, RPB609969S, RPB610019S, RPB610077S, RPB610186S, RPB610230S, RPB610431S, RPB610434S, RPB610437S, RPB610506S, RPB610813S, RPB610882S, RPB610955S, RPB611316S, RPB611327S, RPB611370S, RPB611482S, RPB611609S, RPB611651S, RPB611822S, RPB612129S, RPB612132S, RPB612533S, RPB612628S, RPB612917S, RPB612955S, RPB612965S, RPB613003S, RPB613214S, RPB613216S, RPB613537S, RPB613551S, RPB613616S, RPB613908S, RPB613910S, RPB613976S, RPB614145S, RPB614187S, RPB614232S, RPB614237S, RPB614239S, RPB614283S, RPB614346S, RPB614360S, RPB614447S, RPB615047S, RPB615050S, RPB615066S, RPB615285S, RPB615287S, RPB615306S, RPB615485S, RPB615486S, RPB615736S, RPB615763S, RPB616073S, RPB616074S, RPB616075S, RPB616079S, RPB616277S, RPB616295S, RPB616305S, RPB616362S, RPB616701S, RPB616702S, RPB616936S, RPB617009S, RPB617010S, RPB617045S, RPB617185S, RPB617239S, RPB617552S, RPB617556S, RPB617571S, RPB617578S, RPB617682S, RPB617777S, RPB617779S, RPB617823S, RPB618047S, RPB618077S, RPB618081S, RPB618715S, RPB618751S, RPB618756S, RPB619061S, RPB619083S, RPB619292S, RPB619550S, RPB620063S, RPB620223S, RPB620332S, RPB620426S, RPB620431S, RPB620610S, RPB620818S, RPB621011S, RPB621033S, RPB621072S, RPB621082S, RPB621098S, RPB621481S, RPB621499S, RPB621804S, RPB621810S, RPB621860S, RPB621919S, RPB621921S, RPB622075S, RPB622077S, RPB622117S, RPB622133S, RPB622334S, RPB622444S, RPB622456S, RPB622501S, RPB622507S, RPB622525S, RPB622537S, RPB622541S, RPB622542S, RPB622613S, RPB622711S, RPB622716S, RPB622717S, RPB622782S, RPB622829S, RPB615266S, RPB618599S, RPB618961S, RPB620956S, RPB621701S, RPB621986S, RPB622261S, RPB619043S, RPB621086S, RPB621497S, RPB615265S, RPB609619S, RPB611680S, RPB613119S, RPB618971S, RPB620190S, RPB604094S, RPB604881S, RPB604882S, RPB605651S, RPB606261S, RPB606919S, RPB607473S, RPB607487S, RPB608026S, RPB608305S, RPB608310S, RPB608526S, RPB608545S, RPB603878S, RPB603895S, RPB603897S, RPB603906S, RPB603908S, RPB603918S, RPB603919S, RPB603922S, RPB604273S, RPB604279S, RPB604340S, RPB604427S, RPB604858S, RPB604880S, RPB606025S, RPB606026S, RPB606251S, RPB606256S, RPB606257S, RPB606262S, RPB606949S, RPB607469S, RPB607470S, RPB607477S, RPB607481S, RPB607483S, RPB608068S, RPB608319S, RPB608524S, RPB608525S, RPB608540S, RPB608541S, RPB608542S, RPB608795S, RPB615963S, RPB604682S, RPB604683S, RPB604684S, RPB604685S, RPB604686S, RPB606308S, RPB606309S, RPB606756S, RPB606757S, RPB606760S, RPB607369S, RPB607370S, RPB607732S, RPB608462S, RPB608505S, RPB609311S, RPB609312S, RPB609313S, RPB609314S, RPB609696S, RPB609697S, RPB610047S, RPB610048S, RPB610049S, RPB610050S, RPB610051S, RPB610052S, RPB612442S, RPB612478S, RPB612508S, RPB615301S, RPB615303S, RPB615316S, RPB615321S, RPB615513S, RPB615514S, RPB615516S, RPB615517S, RPB615667S, RPB615668S, RPB615672S, RPB615678S, RPB621321S, RPB622371S, RPB622372S, RPB622697S, RPB622698S, RPB622816S, RPB622817S, RPB608750S, RPB608992S, RPB615850S, RPB606694S, RPB608242S, RPB608949S, RPB608952S, RPB608241S, RPB609164S, RPB618247S, RPB617719S, RPB604374S, RPB607754S, RPB607779S, RPB608239S, RPB609109S, RPB622612S, RPB608232S, RPB609999S, RPB611710S, RPB613174S, RPB613641S, RPB616819S, RPB610887S, RPB610081S, RPB606751S, RPB606820S, RPB607586S, RPB608250S, RPB611051S, RPB611122S, RPB622420S, RPB608672S, RPB611267S, RPB612684S, RPB606303S, RPB610372S, RPB611817S, RPB612476S, RPB612797S, RPB616757S, RPB618569S, RPB619786S, RPB620016S, RPB620157S, RPB620501S, RPB621543S, RPB621544S, RPB621638S, RPB621653S, RPB621655S, RPB621747S, RPB622080S, RPB622298S, RPB622621S, RPB622830S, RPB604086S, RPB604087S, RPB604220S, RPB604383S, RPB604405S, RPB604479S, RPB604927S, RPB605608S, RPB606033S, RPB606237S, RPB606909S, RPB607945S, RPB608015S, RPB608389S, RPB608791S, RPB609206S, RPB609700S, RPB611112S, RPB612236S, RPB612607S, RPB613127S, RPB613948S, RPB614350S, RPB614895S, RPB615329S, RPB615794S, RPB616467S, RPB616774S, RPB619816S, RPB620007S, RPB620201S, RPB620336S, RPB621380S, RPB621422S, RPB621569S, RPB621589S, RPB622311S, RPB622377S, RPB622559S, RPB622853S, RPB611447S, RPB620559S, RPB621342S, RPB607507S, RPB609222S, RPB610747S, RPB617508S, RPB617912S, RPB621461S, RPB621622S, RPB622309S, RPB603842S, RPB604142S, RPB604887S, RPB605595S, RPB605599S, RPB605717S, RPB605905S, RPB606073S, RPB606551S, RPB606851S, RPB606911S, RPB607225S, RPB607352S, RPB607833S, RPB608203S, RPB609514S, RPB609903S, RPB609932S, RPB609979S, RPB610301S, RPB610559S, RPB610876S, RPB611101S, RPB611372S, RPB611459S, RPB611816S, RPB612305S, RPB612806S, RPB613021S, RPB613022S, RPB613057S, RPB613179S, RPB613183S, RPB613728S, RPB613919S, RPB614555S, RPB614557S, RPB614670S, RPB614671S, RPB615497S, RPB615800S, RPB616279S, RPB616750S, RPB616845S, RPB617242S, RPB617358S, RPB617506S, RPB617534S, RPB617854S, RPB617887S, RPB619011S, RPB619399S, RPB619430S, RPB619469S, RPB619817S, RPB619952S, RPB620516S, RPB620518S, RPB620913S, RPB620991S, RPB621109S, RPB621116S, RPB621388S, RPB621473S, RPB621495S, RPB621881S, RPB622144S, RPB622308S, RPB622362S, RPB622767S, RPB622860S, RPB603832S, RPB604357S, RPB605365S, RPB606505S, RPB606730S, RPB606740S, RPB606802S, RPB606808S, RPB606822S, RPB608129S, RPB608225S, RPB608231S, RPB609013S, RPB609661S, RPB609938S, RPB610451S, RPB610509S, RPB610563S, RPB610791S, RPB610793S, RPB611679S, RPB611978S, RPB612460S, RPB612601S, RPB613930S, RPB613950S, RPB614344S, RPB614413S, RPB615767S, RPB616081S, RPB616325S, RPB616665S, RPB609054S, RPB609634S, RPB604873S, RPB610088S, RPB610216S, RPB611403S, RPB612977S, RPB616428S, RPB619523S, RPB606744S, RPB607890S, RPB609330S, RPB613403S, RPB618044S, RPB618110S, RPB618613S, RPB620424S, RPB621491S, RPB605813S, RPB604111S, RPB604587S, RPB607870S, RPB607915S, RPB608081S, RPB608361S, RPB608864S, RPB608907S, RPB610237S, RPB610571S, RPB613177S, RPB613947S, RPB617005S, RPB617997S, RPB618549S, RPB619509S, RPB621315S, RPB621741S, RPB622446S, RPB604400S, RPB606587S, RPB607005S, RPB608264S, RPB611029S, RPB612163S, RPB613911S, RPB617848S, RPB622161S, RPB616049S, RPB616929S, RPB621483S, RPB620816S, RPB605744S, RPB608937S, RPB613906S, RPB621074S, RPB608455S, RPB611709S, RPB612030S, RPB612064S, RPB612524S, RPB615295S, RPB615327S, RPB616709S, RPB618347S, RPB618793S, RPB619331S, RPB619811S, RPB620152S, RPB620153S, RPB605693S, RPB609048S, RPB613070S, RPB608208S, RPB613154S, RPB606577S, RPB606852S, RPB607809S, RPB608245S, RPB608246S, RPB609511S, RPB612914S, RPB613867S, RPB614446S, RPB616036S, RPB616742S, RPB620104S, RPB620845S, RPB622624S, RPB616909S, RPB617025S, RPB617284S, RPB618054S, RPB618311S, RPB619330S, RPB619480S, RPB620891S, RPB603994S, RPB603996S, RPB607639S, RPB608789S, RPB610160S, RPB611178S, RPB611569S, RPB612842S, RPB613842S, RPB614056S, RPB614057S, RPB614528S, RPB614907S, RPB615247S, RPB615250S, RPB615509S, RPB615631S, RPB615730S, RPB617419S, RPB617483S, RPB618288S, RPB619429S, RPB621020S, RPB621024S, RPB621522S, RPB622635S, RPB604199S, RPB604354S, RPB606961S, RPB607084S, RPB615076S, RPB618086S, RPB618654S, RPB619730S, RPB620055S, RPB607444S, RPB614416S, RPB616420S, RPB620681S, RPB620857S, RPB620861S, RPB620864S, RPB620868S, RPB611069S, RPB613609S, RPB614288S, RPB615185S, RPB615827S, RPB620102S, RPB603776S, RPB604519S, RPB605994S, RPB607406S, RPB608263S, RPB611534S, RPB612105S, RPB605822S, RPB609698S, RPB616310S, RPB616686S, RPB621016S, RPB611197S, RPB613225S, RPB615738S, RPB616363S, RPB616951S, RPB617052S, RPB618065S, RPB618577S, RPB620042S, RPB620163S, RPB620644S, RPB620808S, RPB620817S, RPB621103S, RPB622152S, RPB622340S, RPB622480S, RPB620080S, RPB608132S, RPB612106S, RPB614252S, RPB616740S, RPB616827S, RPB616836S, RPB619957S, RPB604879S, RPB604885S, RPB607000S, RPB607843S, RPB609983S, RPB609984S, RPB610072S, RPB612737S, RPB615268S, RPB615829S, RPB616423S, RPB617243S, RPB617943S, RPB621464S, RPB621793S, RPB606304S, RPB609115S, RPB610188S, RPB614195S, RPB614398S, RPB615402S, RPB616697S, RPB617589S, RPB617861S, RPB619785S, RPB620009S, RPB620355S, RPB621790S, RPB621791S, RPB622479S, RPB622694S, RPB608470S, RPB608647S, RPB611336S, RPB612050S, RPB613108S, RPB613420S, RPB613913S, RPB614783S, RPB614908S, RPB616076S, RPB618361S, RPB613599S, RPB618670S, RPB618675S, RPB608664S, RPB604195S, RPB606796S, RPB608443S, RPB608961S, RPB611285S, RPB613350S, RPB613415S, RPB613889S, RPB614993S, RPB615750S, RPB617706S, RPB617843S, RPB618806S, RPB619727S, RPB619733S, RPB620185S, RPB620622S, RPB620661S, RPB621028S, RPB604741S, RPB605369S, RPB605814S, RPB605825S, RPB606009S, RPB606011S, RPB606207S, RPB606788S, RPB606964S, RPB607094S, RPB607601S, RPB608262S, RPB608388S, RPB608394S, RPB608638S, RPB608876S, RPB609671S, RPB609981S, RPB610811S, RPB612098S, RPB612596S, RPB612615S, RPB612751S, RPB613192S, RPB614069S, RPB614087S, RPB614427S, RPB614622S, RPB615069S, RPB615253S, RPB615300S, RPB615545S, RPB615547S, RPB615645S, RPB615804S, RPB615807S, RPB615843S, RPB615845S, RPB616285S, RPB616331S, RPB616410S, RPB616694S, RPB616913S, RPB616994S, RPB617055S, RPB618059S, RPB618101S, RPB618363S, RPB619455S, RPB619806S, RPB619838S, RPB620135S, RPB620179S, RPB620377S, RPB606487S, RPB606552S, RPB607402S, RPB607425S, RPB607667S, RPB608501S, RPB609322S, RPB610091S, RPB610163S, RPB610498S, RPB611006S, RPB611453S, RPB611601S, RPB611850S, RPB612118S, RPB612439S, RPB613000S, RPB614236S, RPB615200S, RPB616071S, RPB616333S, RPB616372S, RPB617235S, RPB617525S, RPB617545S, RPB617957S, RPB617962S, RPB618056S, RPB618447S, RPB619633S, RPB619893S, RPB620047S, RPB620131S, RPB620192S, RPB620285S, RPB620586S, RPB621333S, RPB621382S, RPB622620S, RPB622856S, RPB622859S, RPB606083S, RPB606086S, RPB606087S, RPB616758S, RPB618534S, RPB618535S, RPB619148S, RPB604874S, RPB606910S, RPB610210S, RPB610245S, RPB610371S, RPB611093S, RPB611588S, RPB611876S, RPB612137S, RPB612242S, RPB612808S, RPB612959S, RPB614356S, RPB615136S, RPB616084S, RPB616256S, RPB617111S, RPB617606S, RPB618032S, RPB618510S, RPB620601S, RPB621251S, RPB621894S, RPB622143S, RPB604017S, RPB604605S, RPB612590S, RPB605907S, RPB606036S, RPB606055S, RPB606075S, RPB606470S, RPB606687S, RPB608227S, RPB608429S, RPB609997S, RPB610310S, RPB610675S, RPB610907S, RPB610957S, RPB610958S, RPB610959S, RPB611141S, RPB611281S, RPB611431S, RPB611450S, RPB611713S, RPB613085S, RPB613228S, RPB613996S, RPB614886S, RPB615094S, RPB615384S, RPB616080S, RPB616358S, RPB616720S, RPB616723S, RPB616754S, RPB616755S, RPB616844S, RPB617293S, RPB617694S, RPB618033S, RPB618805S, RPB620390S, RPB620517S, RPB620558S, RPB620836S, RPB621092S, RPB621110S, RPB621343S, RPB621719S, RPB621977S, RPB622520S, RPB622550S, RPB610185S, RPB610878S, RPB611066S, RPB611360S, RPB611448S, RPB611714S, RPB611724S, RPB611813S, RPB612701S, RPB613622S, RPB613694S, RPB613727S, RPB613777S, RPB613877S, RPB614590S, RPB614998S, RPB615417S, RPB615830S, RPB619013S, RPB619780S, RPB620253S, RPB620616S, RPB620800S, RPB620865S, RPB621480S, RPB621628S, RPB621770S, RPB621789S, RPB621797S, RPB621889S, RPB622007S, RPB622046S, RPB622053S, RPB622352S, RPB604584S, RPB605594S, RPB606107S, RPB606263S, RPB606451S, RPB606696S, RPB606895S, RPB6... |
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.