Recall archive / FDA device enforcement
CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; Implantable Cardioverter Defibrillators — FDA record Z-1753-2023
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 DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; 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
- 11794 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1753-2023
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 00643169837676, Lot Serial Numbers: RPT208454H, RPT211000H, RPT208258H, RPT211071H, RPT211077H, RPT210886H, RPT209224H, RPT211338H, RPT211343H, RPT211344H, RPT211347H, RPT208864H, RPT210392H, RPT204063H, RPT207540H, RPT210779H, RPT211477H, RPT210662H, RPT203810H, RPT204233H, RPT210695H, RPT204352H, RPT204713H, RPT205727H, RPT208222H, RPT208507H, RPT210829H, RPT211217H, RPT206139H, RPT207062H, RPT210688H, RPT210917H, RPT203993H, RPT205235H, RPT205768H, RPT206518H, RPT206833H, RPT209343H, RPT209843H, RPT205560H, RPT206519H, RPT210915H, RPT210978H, RPT207320H, RPT204196H, RPT205788H, RPT207588H, RPT209206H, RPT209796H, RPT210253H, RPT210444H, RPT210700H, RPT211542H, RPT211685H, RPT205575H, RPT205841H, RPT207926H, RPT204420H, RPT205180H, RPT204120H, RPT204133H, RPT209974H, RPT205340H, RPT209909H, RPT210452H, RPT211124H, RPT203859H, RPT205468H, RPT208257H, RPT208621H, RPT209674H, RPT211043H, RPT210842H, RPT211476H, RPT207094H, RPT208370H, RPT206004H, RPT206049H, RPT210092H, RPT210217H, RPT211406H, RPT204980H, RPT205294H, RPT208424H, RPT208705H, RPT209144H, RPT209238H, RPT209858H, RPT210083H, RPT210593H, RPT210747H, RPT210979H, RPT211230H, RPT211701H, RPT209577H, RPT209848H, RPT211158H, RPT205289H, RPT206148H, RPT209521H, RPT204605H, RPT206936H, RPT207571H, RPT209334H, RPT209373H, RPT204461H, RPT207429H, RPT209096H, RPT210964H, RPT211140H, RPT205903H, RPT208605H, RPT211566H, RPT206634H, RPT203640H, RPT203792H, RPT203793H, RPT203795H, RPT204568H, RPT204574H, RPT204577H, RPT204582H, RPT204584H, RPT204607H, RPT205619H, RPT205620H, RPT205622H, RPT205624H, RPT206785H, RPT207549H, RPT207550H, RPT207556H, RPT207561H, RPT207562H, RPT207566H, RPT207568H, RPT208590H, RPT208591H, RPT208597H, RPT208599H, RPT208601H, RPT209722H, RPT210663H, RPT210668H, RPT210670H, RPT208269H, RPT206355H, RPT208891H, RPT205697H, RPT205434H, RPT210488H, RPT204439H, RPT207232H, RPT208034H, RPT209462H, RPT203726H, RPT206932H, RPT207021H, RPT210596H, RPT211478H, RPT210913H, RPT203791H, RPT205433H, RPT206774H, RPT211487H, RPT209945H, RPT211316H, RPT204451H, RPT204615H, RPT204619H, RPT204621H, RPT205498H, RPT208563H, RPT208821H, RPT208827H, RPT208828H, RPT208831H, RPT208832H, RPT210307H, RPT210309H, RPT210310H, RPT210311H, RPT211219H, RPT209965H, RPT210101H, RPT210345H, RPT210552H, RPT207931H, RPT210890H, RPT205714H, RPT208626H, RPT211368H, RPT210287H, RPT204343H, RPT204808H, RPT205191H, RPT209632H, RPT208738H, RPT209129H, RPT210394H, RPT204415H, RPT207421H, RPT207989H, RPT210527H, RPT211328H, RPT205965H, RPT206335H, RPT206424H, RPT209985H, RPT210011H, RPT210059H, RPT211191H, RPT205364H, RPT206230H, RPT206334H, RPT206385H, RPT206976H, RPT207522H, RPT208545H, RPT208903H, RPT208906H, RPT208915H, RPT209293H, RPT209676H, RPT210254H, RPT210255H, RPT210532H, RPT210741H, RPT210809H, RPT211032H, RPT211035H, RPT205146H, RPT205305H, RPT205784H, RPT206448H, RPT206681H, RPT206777H, RPT206802H, RPT208470H, RPT209142H, RPT209337H, RPT210051H, RPT211377H, RPT211604H, RPT205145H, RPT209016H, RPT210282H, RPT210285H, RPT205369H, RPT206172H, RPT206278H, RPT206772H, RPT208248H, RPT208405H, RPT208707H, RPT209515H, RPT209587H, RPT210824H, RPT211039H, RPT211110H, RPT211489H, RPT211605H, RPT205266H, RPT208558H, RPT206676H, RPT204489H, RPT210845H, RPT204392H, RPT204589H, RPT204623H, RPT204638H, RPT205654H, RPT206658H, RPT206664H, RPT206666H, RPT207760H, RPT207761H, RPT207762H, RPT207763H, RPT209002H, RPT209004H, RPT209014H, RPT209023H, RPT209420H, RPT209430H, RPT209434H, RPT209457H, RPT205685H, RPT207304H, RPT208164H, RPT205392H, RPT206177H, RPT207338H, RPT207747H, RPT208247H, RPT209537H, RPT210805H, RPT208813H, RPT209285H, RPT210577H, RPT210578H, RPT204515H, RPT204726H, RPT206450H, RPT206533H, RPT207438H, RPT209572H, RPT209905H, RPT207529H, RPT204043H, RPT204860H, RPT205662H, RPT208007H, RPT208009H, RPT208638H, RPT209400H, RPT210870H, RPT205852H, RPT205935H, RPT205936H, RPT205939H, RPT205943H, RPT206796H, RPT206798H, RPT206799H, RPT206800H, RPT206807H, RPT206814H, RPT207836H, RPT207837H, RPT207838H, RPT208838H, RPT208961H, RPT209268H, RPT209619H, RPT206700H, RPT208088H, RPT204721H, RPT204737H, RPT207014H, RPT207015H, RPT208712H, RPT208713H, RPT210280H, RPT210281H, RPT211186H, RPT211187H, RPT211188H, RPT209672H, RPT204699H, RPT205123H, RPT205402H, RPT205873H, RPT206128H, RPT205863H, RPT206274H, RPT211137H, RPT203662H, RPT204188H, RPT204421H, RPT204882H, RPT205454H, RPT206091H, RPT206106H, RPT207587H, RPT208954H, RPT209100H, RPT210137H, RPT210161H, RPT210288H, RPT204812H, RPT208677H, RPT204042H, RPT205723H, RPT207300H, RPT203684H, RPT206793H, RPT206939H, RPT210564H, RPT210570H, RPT211335H, RPT211716H, RPT204436H, RPT204493H, RPT204495H, RPT205627H, RPT206764H, RPT206765H, RPT209347H, RPT209348H, RPT206447H, RPT209178H, RPT210867H, RPT204074H, RPT207657H, RPT204809H, RPT208524H, RPT209067H, RPT209328H, RPT205229H, RPT206473H, RPT206556H, RPT208066H, RPT206235H, RPT207004H, RPT204630H, RPT206883H, RPT206323H, RPT204127H, RPT204710H, RPT204761H, RPT206013H, RPT206684H, RPT207947H, RPT208090H, RPT208456H, RPT208612H, RPT208640H, RPT208904H, RPT209635H, RPT209648H, RPT210205H, RPT210272H, RPT210376H, RPT211465H, RPT211214H, RPT211037H, RPT208288H, RPT209022H, RPT204972H, RPT206184H, RPT207070H, RPT204192H, RPT204193H, RPT205078H, RPT205691H, RPT208072H, RPT209840H, RPT209919H, RPT210517H, RPT210945H, RPT208726H, RPT203877H, RPT206271H, RPT204791H, RPT206006H, RPT206503H, RPT208749H, RPT208963H, RPT204002H, RPT204920H, RPT204925H, RPT205717H, RPT206918H, RPT207887H, RPT209130H, RPT206954H, RPT208586H, RPT209492H, RPT210286H, RPT203638H, RPT204871H, RPT206039H, RPT208431H, RPT209088H, RPT208861H, RPT203652H, RPT203803H, RPT204702H, RPT204865H, RPT206464H, RPT207928H, RPT208553H, RPT208951H, RPT209338H, RPT209636H, RPT210209H, RPT210941H, RPT211602H, RPT211609H, RPT206308H, RPT206638H, RPT208546H, RPT210129H, RPT204465H, RPT205308H, RPT205405H, RPT206260H, RPT207538H, RPT208747H, RPT209898H, RPT210856H, RPT211069H, RPT211351H, RPT211394H, RPT205211H, RPT211449H, RPT209856H, RPT206333H, RPT208477H, RPT208957H, RPT210099H, RPT210132H, RPT203701H, RPT203946H, RPT208206H, RPT208867H, RPT209629H, RPT210937H, RPT211116H, RPT211129H, RPT211296H, RPT211707H, RPT203745H, RPT203831H, RPT203908H, RPT210678H, RPT211543H, RPT208781H, RPT209801H, RPT210565H, RPT208927H, RPT210654H, RPT210675H, RPT211472H, RPT204835H, RPT206571H, RPT207115H, RPT207628H, RPT206630H, RPT206988H, RPT207150H, RPT207535H, RPT211594H, RPT204749H, RPT209595H, RPT210122H, RPT203913H, RPT204205H, RPT205046H, RPT205047H, RPT206459H, RPT206465H, RPT204329H, RPT208776H, RPT209065H, RPT204912H, RPT206094H, RPT209003H, RPT207111H, RPT203646H, RPT203657H, RPT203687H, RPT203727H, RPT203887H, RPT204277H, RPT204361H, RPT204469H, RPT204757H, RPT204777H, RPT204903H, RPT204958H, RPT205209H, RPT205630H, RPT206015H, RPT207423H, RPT208000H, RPT208214H, RPT208300H, RPT208379H, RPT208651H, RPT208845H, RPT209159H, RPT209164H, RPT209309H, RPT209368H, RPT209461H, RPT209805H, RPT209880H, RPT210061H, RPT210146H, RPT210158H, RPT210169H, RPT210177H, RPT210401H, RPT210461H, RPT211048H, RPT211189H, RPT211522H, RPT203781H, RPT204782H, RPT204893H, RPT205270H, RPT205531H, RPT205566H, RPT205577H, RPT206035H, RPT206291H, RPT206345H, RPT206628H, RPT207359H, RPT207381H, RPT208354H, RPT209495H, RPT209593H, RPT209863H, RPT210744H, RPT210930H, RPT211301H, RPT211302H, RPT211313H, RPT211694H, RPT206781H, RPT209025H, RPT209445H, RPT210400H, RPT210424H, RPT204252H, RPT204863H, RPT204881H, RPT206407H, RPT204345H, RPT207292H, RPT207739H, RPT205036H, RPT205429H, RPT207189H, RPT207985H, RPT208531H, RPT208585H, RPT210764H, RPT211546H, RPT211551H, RPT205030H, RPT205160H, RPT205161H, RPT205224H, RPT205247H, RPT205425H, RPT205605H, RPT207032H, RPT207363H, RPT207420H, RPT207984H, RPT208041H, RPT208306H, RPT209273H, RPT210769H, RPT210989H, RPT210990H, RPT211329H, RPT211451H, RPT204132H, RPT204011H, RPT204833H, RPT205282H, RPT205313H, RPT206053H, RPT206343H, RPT206398H, RPT207660H, RPT208360H, RPT209175H, RPT209215H, RPT209924H, RPT210094H, RPT211509H, RPT207589H, RPT209083H, RPT209091H, RPT209093H, RPT211357H, RPT211622H, RPT211624H, RPT211630H, RPT211631H, RPT211637H, RPT204424H, RPT204825H, RPT204964H, RPT203958H, RPT204256H, RPT204410H, RPT204821H, RPT206880H, RPT206946H, RPT208161H, RPT208860H, RPT209704H, RPT209791H, RPT209986H, RPT210166H, RPT205185H, RPT207025H, RPT208779H, RPT210899H, RPT208681H, RPT208829H, RPT208897H, RPT210384H, RPT210858H, RPT210938H, RPT211590H, RPT204672H, RPT205568H, RPT206697H, RPT209920H, RPT210064H, RPT204294H, RPT204532H, RPT206499H, RPT207129H, RPT203898H, RPT204456H, RPT204775H, RPT205231H, RPT206261H, RPT208344H, RPT210539H, RPT203797H, RPT205876H, RPT208670H, RPT207167H, RPT209854H, RPT210296H, RPT210898H, RPT211117H, RPT205663H, RPT205664H, RPT205665H, RPT205666H, RPT205668H, RPT206606H, RPT206920H, RPT206921H, RPT206923H, RPT206924H, RPT206925H, RPT206927H, RPT206928H, RPT206934H, RPT207209H, RPT207352H, RPT207353H, RPT207580H, RPT207666H, RPT207667H, RPT207671H, RPT207827H, RPT207872H, RPT207876H, RPT207938H, RPT207975H, RPT210151H, RPT210191H, RPT210194H, RPT211072H, RPT211073H, RPT211076H, RPT204101H, RPT205242H, RPT205504H, RPT205897H, RPT206869H, RPT210454H, RPT210608H, RPT210866H, RPT211246H, RPT208425H, RPT209616H, RPT204442H, RPT206830H, RPT208416H, RPT208964H, RPT209227H, RPT210554H, RPT203647H, RPT204855H, RPT210248H, RPT211597H, RPT205761H, RPT207596H, RPT208499H, RPT208500H, RPT208709H, RPT205457H, RPT208871H, RPT211007H, RPT203894H, RPT204327H, RPT205057H, RPT205678H, RPT205893H, RPT207159H, RPT207289H, RPT208030H, RPT208084H, RPT208402H, RPT208582H, RPT209527H, RPT211378H, RPT203707H, RPT203714H, RPT205113H, RPT205134H, RPT205404H, RPT205414H, RPT205888H, RPT205975H, RPT206622H, RPT206885H, RPT207169H, RPT207172H, RPT207195H, RPT207752H, RPT208873H, RPT209877H, RPT210382H, RPT205032H, RPT206266H, RPT206968H, RPT211415H, RPT211516H, RPT208091H, RPT208410H, RPT209756H, RPT210355H, RPT210526H, RPT210658H, RPT210988H, RPT207301H, RPT206047H, RPT209053H, RPT209708H, RPT210957H, RPT211676H, RPT205572H, RPT210292H, RPT210303H, RPT210324H, RPT210861H, RPT211536H, RPT208128H, RPT209736H, RPT211326H, RPT204924H, RPT205262H, RPT207133H, RPT210487H, RPT205385H, RPT211303H, RPT209647H, RPT210618H, RPT208063H, RPT208375H, RPT209866H, RPT210131H, RPT210263H, RPT203718H, RPT204432H, RPT206205H, RPT206701H, RPT207230H, RPT207569H, RPT208842H, RPT210950H, RPT210999H, RPT211024H, RPT204827H, RPT207599H, RPT205063H, RPT205064H, RPT205124H, RPT205230H, RPT208602H, RPT211232H, RPT207340H, RPT208052H, RPT208778H, RPT208890H, RPT209524H, RPT210912H, RPT211322H, RPT203907H, RPT204762H, RPT204802H, RPT205670H, RPT206862H, RPT208750H, RPT208931H, RPT208977H, RPT209316H, RPT209888H, RPT209989H, RPT210201H, RPT210331H, RPT210366H, RPT210493H, RPT210986H, RPT211265H, RPT211430H, RPT211457H, RPT211635H, RPT211658H, RPT205776H, RPT210602H, RPT204373H, RPT204838H, RPT205126H, RPT205919H, RPT207110H, RPT207295H, RPT207544H, RPT208092H, RPT208418H, RPT208527H, RPT210914H, RPT211405H, RPT203715H, RPT206522H, RPT203984H, RPT204931H, RPT205204H, RPT206140H, RPT206406H, RPT207107H, RPT209857H, RPT206071H, RPT204935H, RPT205831H, RPT205834H, RPT205837H, RPT206905H, RPT206979H, RPT206984H, RPT208743H, RPT208744H, RPT208851H, RPT208852H, RPT209459H, RPT209463H, RPT209465H, RPT209468H, RPT209470H, RPT210159H, RPT210220H, RPT210222H, RPT211220H, RPT211223H, RPT211224H, RPT211229H, RPT203799H, RPT207904H, RPT204330H, RPT204884H, RPT206213H, RPT206241H, RPT206661H, RPT207314H, RPT207436H, RPT207437H, RPT207748H, RPT208741H, RPT208846H, RPT209611H, RPT209788H, RPT210005H, RPT211628H, RPT207954H, RPT211400H, RPT204308H, RPT204395H, RPT204633H, RPT204634H, RPT205053H, RPT205409H, RPT205508H, RPT205509H, RPT210405H, RPT210587H, RPT210620H, RPT211017H, RPT211067H, RPT211310H, RPT211714H, RPT211715H, RPT209060H, RPT210320H, RPT207247H, RPT208603H, RPT204021H, RPT207173H, RPT210514H, RPT208175H, RPT210728H, RPT206786H, RPT2... |
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.