Claria MRI™ CRT-D SureScan™ DTMA1D4 (UDI 00643169543416)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00643169543416), received between Aug 9, 2017 and Jan 23, 2026 — classified as 24 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (13 reports).

3 FDA recall records 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 ↗

2. Dec 19, 2017Class ITerminated

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

   Z-0586-2018 · Root cause: Process design · Recall details · FDA record ↗

3. Dec 9, 2016Class IITerminated

   During internal testing conducted as part of next generation product development, it was discovered that the AdaptivCRT (aCRT) feature of Amplia MRI and Claria MRI CRT -D devices may appear to be enabled when it is not active.

   Z-0962-2017 · Root cause: Software Design Change · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE EPISODES THAT WERE DETECTED AS VENTRICULAR FIBRILLATION (VF) AND FAST VENTRICULAR TACHYCARDIA (FVT). THE CRT-D WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24161572 ↗
• InjuryDec 5, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED POSSIBLE PREMATURE BATTERY DEPLETION. 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 18268996 ↗
• InjuryDec 22, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REACHED POSSIBLE EARLY RECOMMENDED REPLACEMENT TIME (RRT). 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 16039932 ↗
• InjuryJun 22, 2022Premature Discharge of Battery; Premature Discharge of Battery

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14775257 ↗
• InjuryNov 7, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. 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 12763344 ↗
• InjuryNov 1, 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 REMOVED DUE TO A POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12728573 ↗
• InjuryJun 4, 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 AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11938998 ↗
• InjuryMay 10, 2021Protective Measures Problem; Reset Problem; Appropriate Device Problem Term/Code Not Available; Protective Measures Problem; Reset Problem; Appropriate Device Problem Term/Code Not Available

  FOLLOW UP REVEALED THE DEVICE HAD EXPERIENCED A FULL RESET THAT CLEARED THE DEVICE SETTINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797759 ↗
• MalfunctionMay 7, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT WAS TOLD BY A HEALTHCARE PROFESSIONAL FROM THE CLINIC, THAT BASED ON THE MOST RECENT TRANSMISSION, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IS LOSING BATTERY LIFE AT A RAPID PACE. FOLLOW UP YIELDED NO INFORMATION. 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 11791579 ↗
• InjuryApr 29, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  THE DEVICE WAS RE-INTERROGATED TO CLEAR THE RESET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11749266 ↗
• InjuryApr 27, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PACING LEAD, IMPLANTED IN THE HIS BUNDLE AND PLUGGED INTO THE LEFT VENTRICULAR PORT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), EXHIBITED A RISE IN PACING THRESHOLDS TO A LEVEL REQUIRING HIGH OUTPUT AND EVENTUALLY WAS NOT CAPTURING. THE LEAD WAS EXPLANTED AND REPLACED WITH A TRANSVENOUS LEFT VENTRICULAR (LV) LEAD. IT WAS ALSO REPORTED THAT THE CRT-D MAY HAVE EXHIBITED PREMATURE BATTERY DEPLETION DUE TO THE HIGH OUTPUT. 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 11731690 ↗
• MalfunctionApr 26, 2021Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE REMOTE MONITOR WAS UNABLE TO ESTABLISH TELEMETRY WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR ( CRT-D). THE PATIENT REBOOTED THE MONITOR AND RESET THE READER BUT THE ISSUE WAS UNRESOLVED. THE PATIENT WAS REFERRED TO THE CLINIC. THE CRT-D AND MONITOR REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11724673 ↗
• InjuryNov 25, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REACHED POSSIBLE EARLY BATTERY DEPLETION. 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 10906720 ↗
• InjuryNov 17, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RE-SYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. 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 10853796 ↗
• InjuryNov 2, 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 EXPLANTED DUE TO POCKET EROSION AND A POSSIBLE INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 10774855 ↗
• MalfunctionSep 21, 2020Premature Discharge of Battery; Premature Discharge of Battery

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10563452 ↗
• InjuryJul 21, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DUE TO MANY APPROPRIATE ATRIAL ANTI-TACHYCARDIA PACING AND HIGH LEFT VENTRICULAR (LV) LEAD THRESHOLDS. THE DEVICE WAS EXPLANTED AND REPLACED. NO INTERVENTION WAS DONE REGARDING THE LV LEAD AND IT REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10302380 ↗
• InjuryMar 30, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. HIGH PACING OUTPUTS WERE ALSO OBSERVED ON THE HIS BUNDLE PACING LEAD. REPROGRAMMING WAS PERFORMED AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9900556 ↗
• InjuryJan 17, 2020Premature Discharge of Battery; Premature Discharge of Battery

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9604233 ↗
• InjurySep 25, 2019Adverse 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. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9116596 ↗
• InjuryMay 15, 2019Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE WAS REPLACED DUE TO PREMATURE BATTERY DEPLETION. THE BATTERY LONGEVITY WAS LESS THAN EXPECTED. THE DEVICE WENT FROM ELECTIVE REPLACEMENT INDICATOR (ERI) TO END OF SERVICE (EOS) WITHIN TWO WEEKS. THE DEVICE WAS REMOVED AND A NEW DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8613490 ↗
• InjuryMar 13, 2019Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS IN THE CLINIC AFTER RECEIVING A SHOCK FOR T-WAVE OVERSENSING (TWOS) ON THE RIGHT VENTRICULAR (RV) LEAD POST VENTRICULAR SENSE. THE PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID NOT WITHHOLD THERAPY FOR THE TWOS. THE HEALTHCARE PROFESSIONAL (HCP) CALLED THE COMPANY TECHNICAL SERVICES FOR PROGRAMMING CHANGES TO RESOLVE TWOS. THE RV LEAD WAS REPROGRAMMED AND REMAINS IN USE. THE ICD ALSO 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 8416654 ↗
• MalfunctionMay 8, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE BATTERY LONGEVITY DISPLAYED GRAY BAR WHEN INTERROGATED. THE DEVICE WAS REWARMED AND KEPT AT ROM TEMPERATURE AND IT STILL SHOWED GRAY BAR. THE DEVICE WAS NO USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7495959 ↗
• MalfunctionMay 3, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO THE IMPLANT PROCEDURE THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY VOLTAGE WAS BELOW THE LEVEL INDICATED FOR IMPLANT. THE BATTERY VOLTAGE WAS STILL BELOW THE LEVEL INDICATED FOR IMPLANT AFTER THE DEVICE WAS AT ROOM TEMPERATURE FOR A WEEK. THE DEVICE WAS NOT IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7485054 ↗
• MalfunctionApr 25, 2018Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE DEVICE BATTERY STATUS BAR WAS GRAY. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7461723 ↗