Recall archive / FDA device enforcement
CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators — FDA record Z-1755-2023
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 DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; 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
- 8602 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1755-2023
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 00643169837669, Lot Serial numbers: RPS205974H, RPS208665H, RPS206712H, RPS207744H, RPS205038H, RPS205791H, RPS206225H, RPS208216H, RPS206084H, RPS203804H, RPS208198H, RPS208245H, RPS205937H, RPS205565H, RPS206114H, RPS206723H, RPS206730H, RPS206733H, RPS206734H, RPS206754H, RPS207303H, RPS207318H, RPS207338H, RPS207399H, RPS207703H, RPS207711H, RPS207722H, RPS208049H, RPS208505H, RPS208646H, RPS208679H, RPS205303H, RPS205918H, RPS203315H, RPS204385H, RPS205650H, RPS202760H, RPS203013H, RPS203034H, RPS203256H, RPS203610H, RPS205372H, RPS206383H, RPS206771H, RPS207603H, RPS207933H, RPS208110H, RPS208492H, RPS204009H, RPS202981H, RPS207563H, RPS208546H, RPS202245H, RPS203960H, RPS204342H, RPS204357H, RPS205958H, RPS207822H, RPS207840H, RPS207922H, RPS207923H, RPS207984H, RPS208255H, RPS208529H, RPS208575H, RPS208590H, RPS208615H, RPS203563H, RPS206128H, RPS206413H, RPS206762H, RPS207904H, RPS208608H, RPS202171H, RPS202841H, RPS202860H, RPS203565H, RPS204198H, RPS202792H, RPS202793H, RPS206515H, RPS202224H, RPS203192H, RPS203545H, RPS203910H, RPS204035H, RPS204166H, RPS204197H, RPS204394H, RPS204492H, RPS205560H, RPS206777H, RPS207146H, RPS207520H, RPS208166H, RPS204464H, RPS204776H, RPS207117H, RPS204003H, RPS205323H, RPS206063H, RPS208464H, RPS206252H, RPS202211H, RPS202602H, RPS202612H, RPS205006H, RPS205638H, RPS205639H, RPS205710H, RPS205998H, RPS207105H, RPS207368H, RPS207409H, RPS202030H, RPS202067H, RPS202507H, RPS206211H, RPS206605H, RPS207137H, RPS208591H, RPS202053H, RPS202511H, RPS202116H, RPS202210H, RPS202273H, RPS202274H, RPS202276H, RPS202307H, RPS202349H, RPS202427H, RPS202447H, RPS202498H, RPS202527H, RPS202601H, RPS202603H, RPS202605H, RPS203195H, RPS203197H, RPS203431H, RPS203432H, RPS203433H, RPS203435H, RPS203436H, RPS203438H, RPS203439H, RPS203440H, RPS203441H, RPS203442H, RPS203444H, RPS204202H, RPS204209H, RPS204210H, RPS204212H, RPS204215H, RPS204217H, RPS204223H, RPS204926H, RPS204978H, RPS204980H, RPS204983H, RPS204986H, RPS204987H, RPS204988H, RPS204992H, RPS204997H, RPS205262H, RPS205271H, RPS205276H, RPS205277H, RPS205665H, RPS205714H, RPS205717H, RPS205719H, RPS205720H, RPS205737H, RPS205739H, RPS205741H, RPS205742H, RPS205744H, RPS205750H, RPS205751H, RPS205752H, RPS205754H, RPS205755H, RPS205756H, RPS205757H, RPS205758H, RPS205759H, RPS206175H, RPS206179H, RPS206235H, RPS206367H, RPS206371H, RPS206374H, RPS206378H, RPS206379H, RPS207186H, RPS207187H, RPS207247H, RPS207248H, RPS207252H, RPS207253H, RPS207254H, RPS207255H, RPS207256H, RPS207258H, RPS207260H, RPS207264H, RPS207298H, RPS207393H, RPS207402H, RPS207574H, RPS207774H, RPS207994H, RPS208133H, RPS208237H, RPS208240H, RPS208242H, RPS208327H, RPS208457H, RPS207507H, RPS205911H, RPS205204H, RPS206761H, RPS207437H, RPS207712H, RPS204627H, RPS205509H, RPS205082H, RPS202759H, RPS203251H, RPS202130H, RPS202167H, RPS203220H, RPS204656H, RPS205410H, RPS205487H, RPS207695H, RPS207867H, RPS204362H, RPS208517H, RPS203913H, RPS205806H, RPS205807H, RPS205808H, RPS202277H, RPS204053H, RPS205975H, RPS206636H, RPS208079H, RPS208119H, RPS208349H, RPS204604H, RPS205654H, RPS205765H, RPS202490H, RPS203352H, RPS203816H, RPS206903H, RPS202237H, RPS202704H, RPS203037H, RPS203532H, RPS203707H, RPS203763H, RPS204225H, RPS205169H, RPS205364H, RPS205648H, RPS205731H, RPS205789H, RPS206089H, RPS206450H, RPS206537H, RPS207592H, RPS207719H, RPS208334H, RPS202531H, RPS203458H, RPS204162H, RPS205383H, RPS205492H, RPS208444H, RPS207494H, RPS202057H, RPS202202H, RPS202567H, RPS202849H, RPS202906H, RPS202916H, RPS203068H, RPS203332H, RPS203660H, RPS203726H, RPS203796H, RPS204204H, RPS204613H, RPS205849H, RPS205850H, RPS205851H, RPS205852H, RPS206153H, RPS206452H, RPS206455H, RPS206456H, RPS206459H, RPS206963H, RPS208177H, RPS203421H, RPS203524H, RPS203615H, RPS203770H, RPS204642H, RPS205009H, RPS205058H, RPS205134H, RPS205583H, RPS205990H, RPS206633H, RPS206756H, RPS206947H, RPS207473H, RPS207927H, RPS204248H, RPS203955H, RPS206451H, RPS207611H, RPS207945H, RPS202288H, RPS202290H, RPS203479H, RPS204022H, RPS204172H, RPS204173H, RPS205800H, RPS205801H, RPS205802H, RPS205803H, RPS205805H, RPS206527H, RPS206531H, RPS206540H, RPS208266H, RPS202776H, RPS203086H, RPS202768H, RPS203253H, RPS205214H, RPS207088H, RPS207485H, RPS207487H, RPS207488H, RPS207885H, RPS208313H, RPS202656H, RPS205497H, RPS207691H, RPS202052H, RPS202249H, RPS202955H, RPS203776H, RPS203928H, RPS205585H, RPS207002H, RPS207099H, RPS207354H, RPS207447H, RPS207689H, RPS202453H, RPS202547H, RPS203069H, RPS203115H, RPS203163H, RPS203246H, RPS203407H, RPS203971H, RPS204134H, RPS204135H, RPS204139H, RPS204140H, RPS205733H, RPS205951H, RPS206134H, RPS206165H, RPS206213H, RPS206303H, RPS207173H, RPS207184H, RPS207241H, RPS207243H, RPS207249H, RPS203602H, RPS203678H, RPS204908H, RPS206177H, RPS206267H, RPS206555H, RPS204760H, RPS205535H, RPS202140H, RPS203633H, RPS203635H, RPS204218H, RPS204219H, RPS204220H, RPS205880H, RPS205883H, RPS205884H, RPS206407H, RPS202761H, RPS203704H, RPS205380H, RPS202881H, RPS202738H, RPS202799H, RPS203812H, RPS204143H, RPS206221H, RPS206611H, RPS203092H, RPS203824H, RPS207474H, RPS207599H, RPS202781H, RPS204000H, RPS205399H, RPS205642H, RPS206625H, RPS205858H, RPS207910H, RPS202021H, RPS202074H, RPS202573H, RPS202574H, RPS207292H, RPS208244H, RPS208254H, RPS207297H, RPS202655H, RPS203077H, RPS203655H, RPS207436H, RPS205848H, RPS204773H, RPS205886H, RPS207053H, RPS207979H, RPS202035H, RPS202296H, RPS203753H, RPS204353H, RPS205506H, RPS205816H, RPS206044H, RPS206083H, RPS206648H, RPS206770H, RPS207492H, RPS207543H, RPS207914H, RPS208306H, RPS208167H, RPS208419H, RPS208658H, RPS205390H, RPS207954H, RPS208554H, RPS208555H, RPS202718H, RPS202910H, RPS204089H, RPS207768H, RPS207849H, RPS207837H, RPS208118H, RPS208413H, RPS205895H, RPS202976H, RPS203159H, RPS202200H, RPS203162H, RPS203295H, RPS205887H, RPS208633H, RPS203215H, RPS205831H, RPS206886H, RPS207554H, RPS202160H, RPS203327H, RPS207796H, RPS208406H, RPS206749H, RPS202228H, RPS202231H, RPS202874H, RPS203456H, RPS204874H, RPS205547H, RPS206690H, RPS204943H, RPS202400H, RPS203158H, RPS203178H, RPS203934H, RPS204147H, RPS204278H, RPS205362H, RPS205365H, RPS205429H, RPS205953H, RPS206106H, RPS206138H, RPS207815H, RPS207919H, RPS207987H, RPS208362H, RPS208576H, RPS202741H, RPS203951H, RPS206069H, RPS206348H, RPS204270H, RPS205421H, RPS206117H, RPS202314H, RPS202425H, RPS202582H, RPS202945H, RPS203330H, RPS203451H, RPS203566H, RPS203567H, RPS203612H, RPS203818H, RPS203952H, RPS204050H, RPS204071H, RPS204150H, RPS204348H, RPS204443H, RPS204954H, RPS205125H, RPS205163H, RPS205343H, RPS205375H, RPS205814H, RPS207931H, RPS207344H, RPS207397H, RPS208487H, RPS203072H, RPS203381H, RPS206250H, RPS206268H, RPS207607H, RPS207706H, RPS207860H, RPS204922H, RPS202020H, RPS202304H, RPS202982H, RPS203231H, RPS205552H, RPS207790H, RPS203265H, RPS205968H, RPS206533H, RPS206776H, RPS206826H, RPS202083H, RPS203533H, RPS204247H, RPS204860H, RPS206325H, RPS206621H, RPS207119H, RPS207633H, RPS203321H, RPS208161H, RPS206938H, RPS204403H, RPS207683H, RPS203168H, RPS205415H, RPS208169H, RPS205890H, RPS203239H, RPS203775H, RPS206631H, RPS202564H, RPS205300H, RPS205074H, RPS207635H, RPS206802H, RPS202055H, RPS202372H, RPS202636H, RPS202665H, RPS203134H, RPS203255H, RPS203339H, RPS203392H, RPS203741H, RPS203805H, RPS203838H, RPS203865H, RPS203889H, RPS203982H, RPS204015H, RPS204097H, RPS204231H, RPS204241H, RPS204296H, RPS204355H, RPS204441H, RPS204598H, RPS204759H, RPS204778H, RPS204955H, RPS205010H, RPS205079H, RPS205114H, RPS205215H, RPS205240H, RPS205242H, RPS205248H, RPS205289H, RPS205304H, RPS205345H, RPS205431H, RPS205511H, RPS205543H, RPS205569H, RPS205661H, RPS205992H, RPS206052H, RPS206062H, RPS206066H, RPS206192H, RPS206220H, RPS206253H, RPS206259H, RPS206292H, RPS206340H, RPS206423H, RPS206658H, RPS207170H, RPS207981H, RPS208012H, RPS208071H, RPS208138H, RPS208308H, RPS208343H, RPS208348H, RPS202127H, RPS203424H, RPS204387H, RPS206030H, RPS206543H, RPS206549H, RPS208171H, RPS208172H, RPS205977H, RPS206538H, RPS208047H, RPS206126H, RPS208669H, RPS202978H, RPS203083H, RPS203572H, RPS203871H, RPS204148H, RPS208491H, RPS204768H, RPS202460H, RPS202461H, RPS202463H, RPS203291H, RPS203597H, RPS204070H, RPS205211H, RPS205522H, RPS205545H, RPS205904H, RPS205905H, RPS206096H, RPS206301H, RPS206323H, RPS206590H, RPS206591H, RPS207069H, RPS207070H, RPS207143H, RPS207639H, RPS208001H, RPS208352H, RPS208510H, RPS208644H, RPS203028H, RPS202870H, RPS203325H, RPS204607H, RPS205130H, RPS205132H, RPS208057H, RPS202639H, RPS202643H, RPS202644H, RPS205020H, RPS205021H, RPS205187H, RPS205503H, RPS205558H, RPS205778H, RPS205780H, RPS205840H, RPS205853H, RPS205885H, RPS205967H, RPS208423H, RPS208424H, RPS203413H, RPS205862H, RPS202552H, RPS203284H, RPS203521H, RPS203830H, RPS203918H, RPS204008H, RPS204199H, RPS204203H, RPS206783H, RPS206892H, RPS208135H, RPS205908H, RPS207594H, RPS207824H, RPS207917H, RPS202977H, RPS206042H, RPS206620H, RPS206713H, RPS207673H, RPS207808H, RPS208563H, RPS205949H, RPS206794H, RPS207929H, RPS204229H, RPS204323H, RPS204298H, RPS205601H, RPS206005H, RPS206263H, RPS207068H, RPS202282H, RPS203110H, RPS204525H, RPS204119H, RPS204377H, RPS206855H, RPS207018H, RPS207197H, RPS203483H, RPS203484H, RPS203488H, RPS204176H, RPS204177H, RPS204178H, RPS204180H, RPS204181H, RPS204185H, RPS204189H, RPS204190H, RPS204192H, RPS207234H, RPS207238H, RPS207240H, RPS207242H, RPS207244H, RPS207245H, RPS207246H, RPS208314H, RPS208325H, RPS208329H, RPS208332H, RPS208333H, RPS203408H, RPS205446H, RPS207943H, RPS207051H, RPS207148H, RPS207993H, RPS202739H, RPS204118H, RPS205461H, RPS203944H, RPS205419H, RPS206635H, RPS206696H, RPS207893H, RPS208483H, RPS203758H, RPS206314H, RPS203643H, RPS203702H, RPS203903H, RPS203906H, RPS206772H, RPS207160H, RPS207273H, RPS208140H, RPS203249H, RPS203803H, RPS204787H, RPS205209H, RPS205357H, RPS206742H, RPS207832H, RPS208291H, RPS202722H, RPS204059H, RPS204615H, RPS205084H, RPS205095H, RPS207663H, RPS202753H, RPS202291H, RPS202714H, RPS202965H, RPS203216H, RPS203631H, RPS203987H, RPS206671H, RPS207377H, RPS207780H, RPS208123H, RPS205643H, RPS205331H, RPS207930H, RPS206587H, RPS208098H, RPS203081H, RPS207396H, RPS208541H, RPS206384H, RPS207530H, RPS204266H, RPS208605H, RPS203738H, RPS206240H, RPS206738H, RPS207519H, RPS207967H, RPS208249H, RPS208570H, RPS202444H, RPS202451H, RPS203460H, RPS205468H, RPS205603H, RPS205609H, RPS205909H, RPS206091H, RPS206890H, RPS206977H, RPS207387H, RPS208479H, RPS202450H, RPS208353H, RPS202113H, RPS204124H, RPS204343H, RPS204471H, RPS204795H, RPS205086H, RPS205162H, RPS205312H, RPS206228H, RPS206271H, RPS206289H, RPS206355H, RPS207277H, RPS207561H, RPS207616H, RPS208372H, RPS202470H, RPS202471H, RPS202551H, RPS202571H, RPS202590H, RPS202901H, RPS202969H, RPS203225H, RPS203226H, RPS203227H, RPS203230H, RPS203491H, RPS204507H, RPS204508H, RPS204970H, RPS204972H, RPS204976H, RPS205452H, RPS206015H, RPS206187H, RPS206725H, RPS203207H, RPS207517H, RPS207874H, RPS202682H, RPS202791H, RPS203425H, RPS206135H, RPS206657H, RPS207153H, RPS202125H, RPS202143H, RPS202213H, RPS203367H, RPS204418H, RPS205329H, RPS206285H, RPS207717H, RPS208579H, RPS202039H, RPS202128H, RPS203015H, RPS203709H, RPS203762H, RPS204222H, RPS204456H, RPS204779H, RPS204919H, RPS205319H, RPS205657H, RPS206858H, RPS206860H, RPS206861H, RPS207156H, RPS207438H, RPS207848H, RPS208403H, RPS208429H, RPS208514H, RPS208564H, RPS202157H, RPS202672H, RPS202775H, RPS203766H, RPS204280H, RPS205988H, RPS202136H, RPS202921H, RPS204700H, RPS205302H, RPS205559H, RPS207023H, RPS207086H, RPS207315H, RPS207707H, RPS207942H, RPS208022H, RPS208303H, RPS208475H, RPS202893H, RPS203943H, RPS205243H, RPS206049H, RPS203050H, RPS203101H, RPS208433H, RPS203085H, RPS203476H, RPS204920H, RPS204360H, RPS204489H, RPS204852H, RPS205614H, RPS202503H, RPS202762H, RPS203266H, RPS203492H, RPS205068H, RPS205580H, RPS205763H, RPS206295H, RPS207531H, RPS207541H, RPS207547H, RPS208176H, RPS208648H, RPS202668H, RPS203126H, RPS2... |
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.