Viva XT CRT-DRecalls & reported problems across all models

We found 10 models of Viva XT CRT-D by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,919 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2014 and Sep 17, 2026 — classified as 48 deaths, 1,441 injuries, 430 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (591 reports).

4 FDA recall records name at least one of these models by its device identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Viva XT CRT-D recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 10, 2023Open, Classified

   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.

   Z-1731-2023 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

2. May 10, 2023Open, Classified

   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.

   Z-1729-2023 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

3. Feb 3, 2021Open, Classified

   A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

   Z-1306-2021 · Root cause: Device Design · names 3 of these models · Recall details · FDA record ↗

4. Dec 19, 2017Terminated

   Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

   Z-0584-2018 · Root cause: Process design · names 6 of these models · Recall details · FDA record ↗

Most reported Viva XT CRT-D problems

Viva XT CRT-D models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Viva™ XT CRT-D DTBA1D1

  Programmer, pacemaker
  1 recall25 deaths893 reports
• Viva™ XT CRT-D DTBA1D4

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 recalls7 deaths374 reports
• Viva™ XT CRT-D DTBA1D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 recalls8 deaths333 reports
• Viva™ XT CRT-D DTBA1D4

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 recalls1 death58 reports
• Viva™ XT CRT-D DTBA1D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall2 deaths75 reports
• Viva™ XT CRT-D DTBA1D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall1 death65 reports
• Viva™ XT CRT-D DTBA1D4

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall39 reports
• Viva™ XT CRT-D DTBA1D4

  Programmer, pacemaker
  1 recall1 death37 reports
• Viva™ XT CRT-D DTBA1D1

  Programmer, pacemaker
  1 recall1 death30 reports
• Viva™ XT CRT-D DTBA1D4

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall2 deaths15 reports

Recent Viva XT CRT-D adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Battery Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) exhibited an alert for Recommended Replacement Time (RRT), low battery voltage. The CRT-D was explanted and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805924 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to infection with sepsis. No further patient complications have been reported as a result of this event.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 50357773 ↗
• MalfunctionAug 12, 2026Failure to Charge

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) exhibited an alert due to Charge Circuit Timeout.  The CRT-D remains in use.  No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50227191 ↗
• InjuryJul 28, 2026Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that oversensing was noted on the Implantable Cardioverter Defibrillator's (ICD) atrial and ventricular channels due to electromagnetic interference. The patient received high voltage therapies due to the oversensing. The ICD remains in use.  No further patient complications have been reported as a result of this event.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50060112 ↗
• InjuryJul 2, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POSSIBLY DELIVERED AN INAPPROPRIATE SHOCK FOR SUPRA VENTRICULAR TACHYCARDIA (SVT). THE CRT-D DETECTED THE EPISODE AS VENTRICULAR FIBRILLATION (VF). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25697320 ↗
• InjuryMay 14, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED INAPPROPRIATE SHOCKS FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25176486 ↗
• MalfunctionMay 4, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE MAY HAVE MISDETECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) AS NON-SUSTAINED VENTRICULAR TACHYCARDIA. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072611 ↗
• InjuryApr 8, 2026Data Problem

  IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAS NOT BEEN WORKING ANYMORE BECAUSE OF THE BATTERY. IT WAS NOTED THAT THE CRT-D WAS INACTIVATED AND REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24816645 ↗
• InjuryFeb 27, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) ¿FAILED.¿ THE CRT-D WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472882 ↗
• InjuryFeb 5, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED BY THE HEALTH CARE PROFESSIONAL (HCP) THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS, POSSIBLY DUE TO A DEVICE DETECTION ISSUE. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24269275 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23829997 ↗
• MalfunctionDec 12, 2025Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS TONING AND UPON INTERROGATION A CHARGE CIRCUIT TIMEOUT WAS NOTED. THE PATIENT IS ON HOSPICE AND THE CRT-D HAD BEEN AT RECOMMENDED REPLACEMENT TIME (RRT) FOR ABOUT A YEAR. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23789525 ↗
• MalfunctionNov 19, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD AN ELECTROCARDIOGRAM AND WAS TOLD HIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS "NO LONGER WORKING". THE PATIENT HAD NOT HEARD ANY ALERT TONES. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598730 ↗
• DeathNov 14, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY A PATIENT FAMILY REPRESENTATIVE THAT THE PATIENT WAS "SHOCKED FOR THE FIRST TIME EVER WHEN IN A POOL. THE NEW POOL WAS RESURFACED AND THEY REPLACED THE LIGHT AND IT WAS NOT GROUNDED PROPERLY WHEN IT HAPPENED." ADDITIONALLY, IT WAS STATED THAT THE PATIENT WENT TO THE EMERGENCY ROOM AND THE PHYSICIAN COULD NOT GET THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE IN A DIAGNOSTIC MODE. A FIELD REPRESENTATIVE ARRIVED AND PERFORMED A HISTOGRAM AND COULD SEE RIGHT AWAY WHEN THE STRAY VOLTAGE OCCURRED AND WHEN THE PATIENT GOT THE SHOCK. THE FAMILY REPRESENTATIVE ALSO STATED THAT THE INCIDENT IMPACTED QUALITY OF LIFE, AND AFTER THE INCIDENT THE PATIENT BECAME IRRITABLE AS IF EXPERIENCED POST-TRAUMATIC STRESS DISORDER, EXPERIENCED EYE PROBLEMS AND THREE EYE SURGERIES WITHIN THREE WEEKS. THE PATIENT FAMILY REPRESENTATIVE STATED KNOWS THAT ELECTRICAL SHOCKS CAN IMPACT THE EYE BUT NOT SURE IF IT WAS A DIRECT IMPACT AS THE PATIENT NEVER HAD EYE PROBLEMS BEFORE THE INCIDENT. IT WAS ALSO STATED THAT THE PATIENT PASSED AWAY "BUT FROM SOMETHING ELSE, NOT FROM THIS".

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23559830 ↗
• InjuryOct 15, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS FOR AN SUPRA VENTRICULAR T ACHYCARDIA (SVT) EVENT THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT). THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23294509 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls