Viva Quad XT CRT-DRecalls & reported problems across all models

We found 9 models of Viva Quad XT CRT-D by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,202 adverse event reports in the FDA's MAUDE database, received between Jun 9, 2016 and May 21, 2026 — classified as 30 deaths, 833 injuries, 339 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (300 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 Quad 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-1733-2023 · 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-1732-2023 · Root cause: Under Investigation by firm · 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 4 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 3 of these models · Recall details · FDA record ↗

Most reported Viva Quad XT CRT-D problems

Viva Quad XT CRT-D models

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

• Viva™ Quad XT CRT-D DTBA1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 recalls19 deaths620 reports
• Viva™ Quad XT CRT-D DTBA1Q1

  Programmer, pacemaker
  2 recalls6 deaths236 reports
• Viva™ Quad XT CRT-D DTBA1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  2 recalls2 deaths146 reports
• Viva™ Quad XT CRT-D DTBA1Q1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall2 deaths77 reports
• Viva™ Quad XT CRT-D DTBA1QQ

  Programmer, pacemaker
  1 recall47 reports
• Viva™ Quad XT CRT-D DTBA1Q1

  Programmer, pacemaker
  1 recall1 death28 reports
• Viva™ Quad XT CRT-D DTBA1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall15 reports
• Viva™ Quad XT CRT-D DTBA1QQ

  Programmer, pacemaker
  18 reports
• Viva™ Quad XT CRT-D DTBA1Q1

  Programmer, pacemaker
  15 reports

Recent Viva Quad 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.

• MalfunctionMay 21, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THE PATIENT WAS CONCERNED IF THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) "WAS EVEN WORKING". 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 25250378 ↗
• MalfunctionMay 20, 2026Signal Artifact/Noise; Electromagnetic Interference

  IT WAS REPORTED THAT STORED EPISODES REVEALED ELECTROMAGNETIC INTERFERENCE (EMI) AND NOISE THAT TRIGGERED EPISODE MISCLASSIFICATION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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 25229202 ↗
• DeathMay 14, 2026Failure to Deliver Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT'S RELATIVE THAT THE PATIENT PASSED AWAY AND THE DOCTOR WAS REPORTEDLY SURPRISED THAT THE CARDIA CRESY NCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DID NOT "GO OFF". IT WAS ALLEGED THAT THE DEVICE WAS RELATED TO THE PATIENT'S DEATH. ADDITIONAL INFORMATION WAS SOUGHT BUT COULD NOT BE OBTAINED.

  Patient problems: Insufficient Information

  MAUDE report 25174714 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED FOR AN UNKNOWN PERFORMANCE PROBLEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Medical device site infection; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24305470 ↗
• MalfunctionDec 19, 2025Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Device Sensing Problem; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED OVERSENSING/NOISE ON THE RIGHT ATRIAL (RA) CHANNEL RESULTING IN FALSE DETECTION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). IT WAS SUSPECTED THAT THE NOISE/OVERSENSING WAS DUE TO POSSIBLE ELECTROMAGNETIC INTERFERENCE FROM AN EXTERNAL SOURCE, SUCH AS A MAGNET. 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 23853539 ↗
• MalfunctionNov 20, 2025Reset Problem; Reset Problem

  IT WAS REPORTED THAT A FULL ELECTRICAL RESET OCCURRED ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND THE PATIENT EXPERIENCED BRADYCARDIA. THE DEVICE WAS LATER EXPLANTED AND REPLACED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI)/END OF SERVICE (EOS). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 23607454 ↗
• MalfunctionNov 19, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT "I HAD ISSUES WITH FIRST DEVICE. IT ALLOWED THE HEART RATE TO GO WAY TOO HIGH BEFORE REACTING AND IT DID NOT RECOGNIZE TACHYCARDIA AT ALL."  THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS SUBSEQUENTLY EXPLANTED AND REPLACED FOR NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI).  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23595336 ↗
• InjuryNov 5, 2025Failure to Interrogate; Failure to Interrogate

  THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477578 ↗
• InjuryOct 16, 2025Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT'S SIBLING THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED 41 SHOCKS TO THE PATIENT APPROXIMATELY FIVE YEARS AGO AND THAT "IT MESSED HIM UP". THE ICD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; Shock from Patient Lead(s)

  MAUDE report 23308445 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT CRT-D WAS REPROGRAMMED AND IT WAS CONFIRMED THAT THE PATIENT DID NOT HAVE PACEMAKER SYNDROME.

  Patient problems: Swelling/ Edema

  MAUDE report 22800468 ↗
• InjuryJul 22, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY A PATIENT REPRESENTATIVE THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE WAS "DEFECTIVE" AND HAD TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22566402 ↗
• InjuryJul 21, 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 ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FOR SUSPECTED ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CLASSIFIED AS VENTRICULAR FIBRILLATION (VF). THE RIGHT VENTRICULAR (RV) LEAD APPEARED TO BE OVERSENSING AND UNDERSENSING AND THERE WAS AN OBSERVATION FOR T-WAVE OVERSENSING (TWOS). UNDERSENSING WAS ALSO NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE CRT-D, RV LEAD, AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22555783 ↗
• MalfunctionJul 1, 2025Battery Problem; Battery Problem

  THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO REACHING ELECTIVE REPLACEMENT INDICATOR (ERI) AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22371802 ↗
• MalfunctionJun 27, 2025Pacing Problem; Communication or Transmission Problem; Pacing Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT AFTER TRYING MULTIPLE PROGRAMMERS THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS UNABLE TO INTERROGATE.  TROUBLESHOOTING WAS PERFORMED USING VARIOUS TECHNIQUES, INCLUDING MANUAL INTERROGATION WITHOUT WIRELESS TELEMETRY, PATIENT POSITION CHANGES WHILE IN A DIFFERENT ROOM BUT THE CRT-D WAS UNABLE TO INTERROGATE.  ADDITIONALLY, IT WAS NOTED THAT THE CRT-D DID NOT TONE WHEN A MAGNET WAS PLACED OVER THE DEVICE AND THE ELECTROCARDIOGRAM (ECG) SHOWED SINUS BRADYCARDIA WITH LONG PR INTERVALS.  THE CRT-D REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 22345380 ↗
• InjuryJun 16, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THERE WAS A ¿CHANGE IN THE PATIENT¿S CONDITION.¿ THE PATIENT WAS EXPERIENCING SYNCOPE AND THERE WAS CONCERN THAT THE PATIENT WAS HAVING CARDIAC ARRHYTHMIAS OR DEHYDRATION CAUSING THE SYNCOPE. THE PATIENT WAS INSTRUCTED TO HYDRATE. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Dehydration; Syncope/Fainting

  MAUDE report 22213454 ↗

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