Viva™ Quad XT CRT-D DTBA1Q1 (UDI 00643169530164)Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 00643169530164), received between Dec 9, 2016 and May 21, 2026 — classified as 2 deaths, 47 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (9 reports).

1 FDA recall record name this device's identifier, 1 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Feb 3, 2021Class IOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 77 reports, 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 ↗
• DeathMar 31, 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) BECAME INFECTED. THE CRT-D SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information; Medical device site infection

  MAUDE report 21733410 ↗
• InjuryOct 23, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DUE TO THE PHYSICIAN CLAIMS THE DEVICE WAS NOT FUNCTIONING WITHIN NORMAL TOLERANCES.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514829 ↗
• InjuryAug 8, 2023Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE THERAPY DUE TO THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT).  THE DEVICE 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 17481953 ↗
• InjuryJan 17, 2023Adverse 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 AN INFECTION. A TEMPORARY PACING SYSTEM WAS USED UNTIL THE SYSTEM WAS REPLACED THREE DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16186374 ↗
• InjuryMay 16, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POSSIBLY DELIVERED INAPPROPRIATE SHOCKS FOR EPISODES OF ATRIAL FIBRILLATION (AF) WITH A RAPID VENTRICULAR RESPONSE DETECTED AS VENTRICULAR TACHYCARDIA (VT) EPISODES. 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 14408473 ↗
• MalfunctionApr 22, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXHIBITING ABNORMAL BATTERY DEPLETION. THE DEVICE REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14187461 ↗
• InjuryDec 30, 2021Adverse 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 A POCKET INFECTION. A TEMPORARY PACER WAS PLACED AND A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS IMPLANTED TWO DAYS LATER. ANTIBIOTIC TREATMENT WAS PROVIDED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 13118349 ↗
• MalfunctionDec 13, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS FURTHER REPORTED, VIA FOLLOW UP, THAT THE DEVICE WAS CHECKED AND NOTED TO BE FUNCTIONING NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12984360 ↗
• InjuryNov 12, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DUE TO AN UNSPECIFIED ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12803661 ↗
• InjuryOct 15, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT FUNCTIONING WITHIN NORMAL TOLERANCES. THE DEVICE 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 12638685 ↗
• MalfunctionJun 11, 2021Reset Problem; Reset Problem

  IT WAS REPORTED BY THE PATIENT REPRESENTATIVE, THAT WHEN THE DEVICE WAS INTERROGATED AT DEVICE CHECK BY A HEALTHCARE PROFESSIONAL, IT WAS NOTED THAT THE ¿DEVICE IS WIPED CLEAN¿. THE PATIENT REPRESENTATIVE NOTED THAT THIS WAS THE SECOND TIME THEY WERE TOLD THE DEVICE WAS WIPED CLEAN. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11984958 ↗
• MalfunctionJun 11, 2021Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED BY THE PATIENT'S REPRESENTATIVE THAT THE PATIENT WAS SITTING IN THEIR ADJUSTABLE BED, WHICH CONTAINS MAGNETS, WITH THEIR PHONE AND THEY FELT A "LITTLE ELECTRICAL SHOCK." ELECTROMAGNETIC INTERFERENCE WAS SUSPECTED. 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: Electric Shock

  MAUDE report 11983547 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11921302 ↗
• MalfunctionMay 7, 2021Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO DIZZINESS AND A HEART RATE LOWER THAN THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PROGRAMMED LOWER LIMIT. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Dizziness

  MAUDE report 11790664 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THE DVT WAS IDENTIFIED VIA BILATERAL LOWER EXTREMITY ULTRASOUND AS NON-OCCLUSIVE LEFT POPLITEAL DVT. THE PATIENT WAS STARTED ON ANTICOAGULATION THERAPY, HOWEVER IT WAS STOPPED DUE TO THE PATIENT HISTORY OF SEVERE EPITAXIES WHILE ON ANTICOAGULATION THERAPY. A INFERIOR VENA CAVA FILTER WAS PLACED WITHOUT COMPLICATION AND THE DVT WAS INDICATED AS RESOLVED. IT WAS ALSO REPORTED THAT THE DVT WAS NOT RELATED TO THE PRODUCT.

  Patient problems: Chills; Dyspnea; Fever; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 11554909 ↗
• MalfunctionJan 29, 2021Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) COULD NOT BE INTERROGATED AFTER THE PATIENT REPORTED RECEIVING A SHOCK. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11253440 ↗
• InjuryOct 19, 2020Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED EPISODES AND HIGH SHORT V-V INTERVALS. SOME UNDER-SENSING WAS NOTED ON THE STORED ELECTROGRAMS (EGM). IT WAS NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD A CHARGE CIRCUIT TIMEOUT. IT WAS ALSO NOTED THAT THE PHYSICIAN WAS UPSET DUE TO THE PHYSICIAN RESIDENT BEING TOLD TO PLACE A MAGNET ON THE DEVICE WHEN THE PATIENT WAS RECEIVING THERAPY. THE THERAPY WAS INITIALLY THOUGHT TO BE DUE TO OVER-SENSING. THE PHYSICIAN NOTED THAT THE PATIENT WAS IN TRUE VENTRICULAR FIBRILLATION (VF) AND THE THERAPIES WERE APPROPRIATE. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 10697243 ↗
• InjurySep 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 10554031 ↗
• MalfunctionAug 27, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY WAS DEPLETING EARLIER THAN EXPECTED. 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; No Consequences Or Impact To Patient

  MAUDE report 10462852 ↗
• InjuryAug 24, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED HIGH VOLTAGE THERAPY FOR SUSPECTED ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE DURING AN ATRIAL ARRHYTHMIA. 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 10445600 ↗
• InjuryAug 17, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. THE CRT-D WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10414358 ↗
• InjuryAug 4, 2020Adverse 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 REMOVED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10361284 ↗
• InjuryJul 31, 2020Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY DELIVERED FOR SUSPECTED ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. 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 10350473 ↗
• InjuryJul 15, 2020Adverse 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 REMOVED DUE TO A (B)(6) INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10278101 ↗