Viva Quad XT CRT-D recallZ-1732-2023 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) · initiated May 10, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

Medtronic issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its consignees on 05/10/2023 by UPS 2-day delivery or email. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. The notice explained the problem and the risk and requested the following patient management recommendations: - Prophylactic device replacement is NOT recommended. - Program all HV therapy pathways B>AX in all therapy zones to minimize the risk for this issue. - Prioritize reprogramming patients who have both a history of HV therapy and Rx1 programmed AX>B. - For remaining patients with AX>B programming in any HV therapy sequence, schedule (with appropriate discretion) the next follow-up for in-clinic reprogramming to minimize potential for reduced- or no-energy HV therapies to occur. - Contact Medtronic Technical Services (1-800-929-4043) or your local representative if one of the following is observed as these may be an indication of either a device or lead-related issue: o Reduced- or no-energy HV therapy is displayed in Episode Text (regardless of programmed pathway) o A persistent drop of approximately 50% in RA, RV and LV pacing lead impedance measurements as this may be an indication of increased potential for a future reduced- or no-energy therapy. Update 10/10/2023: Beginning 09/27/2023, Medtronic issued communication via letter to consignees regarding the availability of the revised IFU and SmartSync Software. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. Consignees are asked to complete and return a confirmation certificate (or equivalent record) confirming they have received the notification.

Recall details

Recall number: Z-1732-2023
Status: Open, Classified
Initiated by the company: May 10, 2023
Posted by the FDA: Jun 16, 2023
Recalling firm: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Quantity: 373 units
Product code: NIK
FDA submissions: P010031S442
Distribution: US Nationwide - Worldwide Distribution

Product description

CRT-D DTBA1Q1 VIVA QUAD XT IS4/DF1 US, Model Number DTBA1Q1; Implantable Cardioverter Defibrillators

Code information (models, lots, serial numbers)

Show the full code information (5k characters)

GTIN 00643169720190, Lot Serial Numbers: BLD212440H, BLD212962H, BLD212366H, BLD212449H, BLD212473H, BLD212554H, BLD212653H, BLD212675H, BLD212791H, BLD212822H, BLD212902H, BLD212926H, BLD213003H, BLD213009H, BLD212351H, BLD212699H, BLD212811H, BLD212406H, BLD212432H, BLD212306H, BLD212443H, BLD212455H, BLD212472H, BLD212600H, BLD212644H, BLD212839H, BLD212920H, BLD212943H, BLD212349H, BLD212311H, BLD212708H, BLD212781H, BLD212834H, BLD212521H, BLD212566H, BLD212628H, BLD212648H, BLD212782H, BLD212883H, BLD213061H, BLD212483H, BLD212487H, BLD213006H, BLD212452H, BLD212752H, BLD213012H, BLD212357H, BLD212333H, BLD212570H, BLD212638H, BLD212709H, BLD212830H, BLD212915H, BLD212953H, BLD212984H, BLD212996H, BLD213030H, BLD213041H, BLD212586H, BLD212459H, BLD212721H, BLD212843H, BLD213039H, BLD212917H, BLD212427H, BLD211868H, BLD212522H, BLD212412H, BLD212413H, BLD212415H, BLD212416H, BLD212418H, BLD212767H, BLD212842H, BLD212878H, BLD212879H, BLD212898H, BLD212909H, BLD213072H, BLD212376H, BLD212702H, BLD212556H, BLD211866H, BLD212723H, BLD211867H, BLD212688H, BLD212565H, BLD212615H, BLD212627H, BLD212732H, BLD212785H, BLD212912H, BLD212919H, BLD212951H, BLD212993H, BLD213011H, BLD213015H, BLD213032H, BLD213042H, BLD213052H, BLD213053H, BLD212774H, BLD212783H, BLD213035H, BLD213049H, BLD212835H, BLD212538H, BLD212411H, BLD212809H, BLD212925H, BLD213060H, BLD212358H, BLD212762H, BLD212813H, BLD212578H, BLD212625H, BLD212626H, BLD212552H, BLD212729H, BLD212368H, BLD212423H, BLD212425H, BLD212454H, BLD212512H, BLD212561H, BLD212607H, BLD212617H, BLD212743H, BLD212770H, BLD212772H, BLD212820H, BLD212862H, BLD212867H, BLD212884H, BLD212903H, BLD212904H, BLD212942H, BLD212975H, BLD212979H, BLD212981H, BLD212982H, BLD212985H, BLD212987H, BLD212988H, BLD212991H, BLD212994H, BLD212995H, BLD213070H, BLD212560H, BLD212551H, BLD212480H, BLD212481H, BLD212520H, BLD212341H, BLD212350H, BLD212553H, BLD212611H, BLD212649H, BLD212334H, BLD212871H, BLD212682H, BLD212864H, BLD212737H, BLD212798H, BLD212690H, BLD212776H, BLD212622H, BLD212390H, BLD212363H, BLD212514H, BLD213021H, BLD213066H, BLD212761H, BLD212652H, BLD212500H, BLD212356H, BLD212456H, BLD212478H, BLD212833H, BLD212840H, BLD212373H, BLD212868H, BLD213036H, BLD212397H, BLD212567H, BLD212624H, BLD212686H, BLD212745H, BLD212803H, BLD212817H, BLD212893H, BLD212934H, BLD212964H, BLD212992H, BLD213008H, BLD213004H, BLD212526H, BLD212704H, BLD212345H, BLD212692H, BLD212826H, BLD212844H, BLD212977H, BLD212346H, BLD212461H, BLD212395H, BLD212404H, BLD212890H, BLD212408H, BLD212410H, BLD212575H, BLD212661H, BLD212736H, BLD212636H, BLD212447H, BLD212855H, BLD212313H, BLD212444H, BLD212493H, BLD212498H, BLD212501H, BLD212683H, BLD212471H, BLD213062H, BLD212431H, BLD212534H, BLD212539H, BLD212576H, BLD212548H, BLD212620H, BLD212664H, BLD212960H, BLD212535H, BLD212577H, BLD212931H, BLD213063H, BLD212513H, BLD212598H, BLD212712H, BLD212779H, BLD212841H, BLD212876H, BLD212446H, BLD212786H, BLD212711H, BLD212557H, BLD213001H, BLD212451H, BLD212790H, BLD212465H, BLD212564H, BLD212858H, BLD212886H, BLD212583H, BLD212515H, BLD212974H, BLD212829H, BLD212375H, BLD212573H, BLD212632H, BLD212771H, BLD212314H, BLD212354H, BLD212725H, BLD212746H, BLD211870H, BLD212680H, BLD212892H, BLD213034H, BLD212764H, BLD212806H, BLD212718H, BLD212983H, BLD212703H, BLD212726H, BLD212787H, BLD212804H, BLD212927H, BLD213084H, BLD212589H, BLD212305H, BLD212525H, BLD212705H, BLD212735H, BLD212795H, BLD212838H, BLD212845H, BLD213045H, BLD212837H, BLD213075H, BLD212352H, BLD212353H, BLD212380H, BLD212511H, BLD212307H, BLD212719H, BLD212312H, BLD212747H, BLD212792H, BLD213031H, BLD213090H, BLD212330H, BLD212439H, BLD212579H, BLD212630H, BLD212631H, BLD212634H, BLD212821H, BLD212986H, BLD212673H, BLD212655H, BLD212657H, BLD212658H, BLD212659H, BLD212674H, BLD212685H, BLD212695H, BLD212710H, BLD212714H, BLD212733H, BLD212734H, BLD212740H, BLD212728H, BLD212882H, BLD212687H, BLD212731H, BLD212827H, BLD212359H, BLD212533H, BLD212662H, BLD212645H, BLD212751H, BLD212753H, BLD212857H, BLD212972H, BLD212784H, BLD212796H, BLD212907H, BLD212793H, BLD212918H, BLD212361H, BLD212880H, BLD212640H, BLD213019H, BLD212437H, BLD212318H, BLD213005H, BLD212691H, BLD212315H, BLD212805H, BLD213026H, BLD212372H, BLD212309H, BLD212327H, BLD212340H, BLD212801H, BLD212929H, BLD212952H, BLD213085H, BLD212384H, BLD212872H, BLD212958H, BLD212959H, BLD213083H, BLD212466H, BLD213037H, BLD213087H, BLD212759H, BLD212989H, BLD212997H, BLD213043H, BLD212684H, BLD212955H

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Viva™ Quad XT CRT-D DTBA1Q1
Medtronic, Inc. · Programmer, pacemaker
1 recall1 death28 reports

Product lines

Viva Quad XT CRT-DMedtronic, Inc. · 9 models · 1,202 reports · 4 recalls

Other products in the same recall event

The FDA groups related products into one recall event (event 92328).

Z-1704-2023 · Open, Classified
ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; Implantable Cardioverter Defibrillators
Z-1705-2023 · Open, Classified
ICD-DR DDBB1D4 EVERA XT IS1/DF4 US, Model Number DDBB1D4; Implantable Cardioverter Defibrillators
Z-1709-2023 · Open, Classified
ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; Implantable Cardioverter Defibrillators
Z-1710-2023 · Open, Classified
ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter Defibrillators
Z-1711-2023 · Open, Classified
ICD-DR DDMB1D1 EVERA MRI XT US DF1, Model Number DDMB1D1; Implantable Cardioverter Defibrillators
Z-1712-2023 · Open, Classified
ICD-DR DDMB1D4 EVERA MRI XT IS-1/DF4 US, Model Number DDMB1D4; Implantable Cardioverter Defibrillators
Z-1715-2023 · Open, Classified
ICD-DR DDMC3D1 EVERA MRI S OUS/US DF1, Model Number DDMC3D1; Implantable Cardioverter Defibrillators
Z-1716-2023 · Open, Classified
ICD-DR DDMC3D4 EVERA MRI S IS-1/DF4 GLOB, Model Number DDMC3D4; Implantable Cardioverter Defibrillators
Z-1717-2023 · Open, Classified
ICD-DR DDMD3D1 PRIMO MRI, Model Number DDMD3D1; Implantable Cardioverter Defibrillators
Z-1718-2023 · Open, Classified
ICD-DR DDMD3D4 PRIMO MRI, Model Number DDMD3D4; Implantable Cardioverter Defibrillators
Z-1721-2023 · Open, Classified
ICD COBALT XT DR MRI IS1 DF1, Model Number DDPA2D1; Implantable Cardioverter Defibrillators
Z-1723-2023 · Open, Classified
ICD COBALT XT DR MRI IS1 DF4, Model Number DDPA2D4; Implantable Cardioverter Defibrillators
Z-1725-2023 · Open, Classified
ICD COBALT DR MRI IS1 DF1, Model Number DDPB3D1; Implantable Cardioverter Defibrillators
Z-1726-2023 · Open, Classified
ICD COBALT DR MRI IS1 DF4, Model Number DDPB3D4; Implantable Cardioverter Defibrillators
Z-1727-2023 · Open, Classified
ICD CROME DR MRI IS1 DF1, Model Number DDPC3D1; Implantable Cardioverter Defibrillators
Z-1728-2023 · Open, Classified
ICD CROME DR MRI IS1 DF4, Model Number DDPC3D4; Implantable Cardioverter Defibrillators
Z-1729-2023 · Open, Classified
CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; Implantable Cardioverter Defibrillators
Z-1731-2023 · Open, Classified
CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; Implantable Cardioverter Defibrillators
Z-1733-2023 · Open, Classified
CRT-D DTBA1QQ VIVA QUAD XT IS4/DF4 US, Model Number DTBA1QQ; Implantable Cardioverter Defibrillators
Z-1741-2023 · Open, Classified
CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1; Implantable Cardioverter Defibrillators
Z-1742-2023 · Open, Classified
CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; Implantable Cardioverter Defibrillators
Z-1743-2023 · Open, Classified
CRT-D DTBB1Q1 VIVA QUAD S IS4/DF1 US, Model Number DTBB1Q1; Implantable Cardioverter Defibrillators
Z-1744-2023 · Open, Classified
CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; Implantable Cardioverter Defibrillators
Z-1753-2023 · Open, Classified
CRTD DTMA1D1 CLARIA MRI US DF1, Model Number DTMA1D1; Implantable Cardioverter Defibrillators
Z-1754-2023 · Open, Classified
CRTD DTMA1D4 CLARIA MRI US DF4, Model Number DTMA1D4; Implantable Cardioverter Defibrillators
Z-1755-2023 · Open, Classified
CRTD DTMA1Q1 CLARIA MRI QUAD US DF1, Model Number DTMA1Q1; Implantable Cardioverter Defibrillators
Z-1756-2023 · Open, Classified
CRTD DTMA1QQ CLARIA MRI QUAD US DF4, Model Number DTMA1QQ; Implantable Cardioverter Defibrillators
Z-1761-2023 · Open, Classified
CRTD DTMB1D1 AMPLIA MRI US DF1, Model Number DTMB1D1; Implantable Cardioverter Defibrillators
Z-1762-2023 · Open, Classified
CRTD DTMB1D4 AMPLIA MRI US DF4, Model Number DTMB1D4; Implantable Cardioverter Defibrillators
Z-1763-2023 · Open, Classified
CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1, Model Number DTMB1Q1; Implantable Cardioverter Defibrillators

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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