Claria MRI™ CRT-D SureScan™ DTMA1D1 (UDI 00643169837676)Recalls & reported problems

Summary

The FDA's MAUDE database contains 415 adverse event reports that list this exact device (DI 00643169837676), received between Jun 25, 2018 and Sep 25, 2026 — classified as 7 deaths, 230 injuries, 178 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (95 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. May 10, 2023Class IOpen, 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-1753-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 415 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) patient experienced an infection. The device system was explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50897417 ↗
• InjuryAug 11, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that inappropriate Cardiac Resynchronization Therapy Defibrillator (CRT-D) tracking of Atrial Fibrillation (AF)/Atrial Flutter caused elevated ventricular rates (AF with Rapid Ventricular Response) which led to inappropriate therapy delivery. Shortness of breath was noted. Reprogramming was conducted, and the CRT-D remains in use. The patient is a participant in a clinical study.  No further patient complications have been reported as a result of this event.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Dyspnea; Shock from Patient Lead(s)

  MAUDE report 50201486 ↗
• MalfunctionMay 27, 2026Pacing Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IT WAS NOTED THAT PACER SPIKES WERE NOT PICKING UP ON THE MONITOR AND THAT THE PATIENT'S HEART RATE WAS NOTED TO BE IN THE 40S-80S WHICH IS LOWER THE THE PROGRAMMED LOWER RATE SETTING.  THE CRT-P REMAINS IN USE.  IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED CHANGES IN IMPEDANCE THAT WERE FALLING.  THE LV LEAD REMAINS IN USE.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25302665 ↗
• InjuryApr 9, 2026Failure to Interrogate; Communication or Transmission Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM UNCONSCIOUS WITH NO UNDERLYING RHYTHM. ATTEMPTS TO INTERROGATE THE DEVICE WITH TWO DIFFERENT PROGRAMMERS WERE MADE BUT TELEMETRY COULD NOT BE OBTAINED. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Loss of consciousness

  MAUDE report 24831026 ↗
• InjuryAug 27, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED 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 22908942 ↗
• DeathJun 20, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED, BY A REPRESENTATIVE OF THE PATIENT, THAT THE PATIENT HAD PASSED AWAY AND NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) "DID NOT FUNCTION PROPERLY".

  Patient problems: Insufficient Information

  MAUDE report 22302993 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION AND HEALING ISSUES THAT PRESENTED WITH DISCOMFORT, EROSION, PAIN, AND REDNESS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erosion; Erythema; Impaired Healing; Pain; Unspecified Infection

  MAUDE report 22186964 ↗
• InjuryJun 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS CONCERN OF POCKET EROSION OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE CRT-D WAS EXPLANTED AND ALL THE LEADS WERE CAPPED. A LEADLESS PACEMAKER WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 22186239 ↗
• InjuryMay 30, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REACHED RECOMMENDED REPLACEMENT TIME (RRT) SOONER THAN EXPECTED. 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 22116061 ↗
• InjuryMay 8, 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 INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY AFTER THE DEVICE FEATURE, DESIGNED TO WITHHOLD VENTRICULAR TACHYARRHYTHMIA DETECTION WHEN THERE IS SENSED 1:1 ATRIAL TO VENTRICULAR CONDUCTION OF RHYTHMS THAT EXHIBIT A GRADUAL INCREASE IN RATE INTO THE DETECTION ZONE, DETECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) AS FAST VENTRICULAR TACHYCARDIA (FVT). 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 21987330 ↗
• MalfunctionApr 21, 2025Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT HIGH RATE NON-SUSTAINED EPISODES SHOWED SHORT RUNS OF LOW AMPLITUDE NOISE AND OVERSENSING. 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 21877831 ↗
• InjuryApr 21, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MAY HAVE DELIVERED ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) WHICH ADVANCED TO VENTRICULAR FIBRILLATION (VF). IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING POTENTIALLY TRIGGERING THE DEVICE TO FALSELY CLASSIFY ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES AS TERMINATED. THE CRT-D AND RA LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 21875675 ↗
• MalfunctionMar 5, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODES WHICH WERE DETECTED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AS VENTRICULAR TACHYCARDIA (VT). 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 21529949 ↗
• MalfunctionJan 27, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE THERAPY FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR THE DETECTION OF SUPRA VENTRICULAR TACHYCARDIA (SVT) 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21245890 ↗
• InjuryJan 25, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED POSSIBLE PREMATURE BATTERY DEPLETION. ADDITIONALLY, THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND INTERMITTENT CAPTURE. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE LV LEAD WILL CONTINUE TO BE MONITORED AND 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 21236654 ↗
• InjuryJan 2, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. IT WAS ALSO OBSERVED THAT WHEN ATTEMPTING TO INTERROGATE THE DEVICE USING A MOBILE PROGRAMMER, ONLY THE PROGRAMMED LV1-RV-COIL VECTOR WAS VISIBLE WHILE ALL OTHER VECTORS DISAPPEARED. A LEGACY PROGRAMMER WAS USED TO INTERROGATE AND THE OTHER VECTORS WERE AVAILABLE FOR TESTING. 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 21055966 ↗
• InjuryNov 27, 2024Pacing 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 FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR POSSIBLE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE CLASSIFIED AS VENTRICULAR FIBRILLATION (VF). 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 20795367 ↗
• MalfunctionNov 8, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN OFFICE NOTED THAT THE DEVICE WAS CONFIRMED TO BE WORKING APPROPRIATELY. NO ACTIO N/INTERVENTION WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20645544 ↗
• InjurySep 23, 2024Adverse 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 PATIENT HAD TWO CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEMS IMPLANTED AT THE TIME OF THE INFECTION. BOTH OF THE CRT-D SYSTEMS WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 20281855 ↗
• InjurySep 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION WITH SWELLING. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), RIGHT ATRIAL (RA) LEAD, AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED AND NOT REPLACED, AND THE LEFT VENTRICULAR (LV) LEAD WAS CAPPED AND LATER EXPLANTED. A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Swelling/ Edema; Unspecified Infection

  MAUDE report 20276182 ↗
• InjuryAug 7, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISPLAYED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 19934487 ↗
• InjuryAug 6, 2024Pacing 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 THERAPY AND HIGH VOLTAGE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). THE CRT-D REMAINS IN USE. THERE WAS ALSO UNDERSENSING NOTED ON THE RIGHT ATRIAL (RA) LEAD THAT APPEARED TO RESULT IN INAPPROPRIATE ATRIAL PACING. THE LEAD 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 19921562 ↗
• MalfunctionMay 21, 2024Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), QUESTION WAS ASK ABOUT PATIENT'S RIGHT VENTRICULAR OVERSENSING.  IT WAS INDICATED THAT WILL THE PATIENT WAS IN OFFICE, IT WAS NOTED THAT THERE HAD BEEN AN ADDITIONAL OVERSENSING EPISODE THAT THE PATIENT IDENTIFIED AS LIKELY DUE TO EXTERNAL ELECTROMAGNETIC INTERFERENCE (EMI) DUE TO THE PATIENT USING A DRILL AT THE TIME OF THE EPISODE BECAUSE THE PATIENT  STARTED FEELING DIZZY WHILE USING THE DRILL.  THE CRT-D REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 19359103 ↗
• InjuryMay 16, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. ADDITIONALLY, IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLDS. THE LEAD WAS REPROGRAMMED AND 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 19333646 ↗
• MalfunctionMay 9, 2024Pacing Problem; Data Problem; Pacing Problem; Data Problem

  IT WAS REPORTED THAT DURING USE OF RIGHT VENTRICULAR (RV) LEAD, A WARNING TRIGGERED FOR RVTIP TO RVCOIL LEAD IMPEDANCE HOWEVER, THE MEASUREMENT RETURNED TO WITHIN EXPECTED RANGE.  ADDITIONALLY, THE RV LEAD DEFIB IMPEDANCE MEASUREMENT WAS NOTED TO BE TRENDING UP ON LEAD TRENDS.  THE RV LEAD REMAINS IN USE.  IT WAS ALSO REPORTED THAT THE PATIENT'S HEART RATE DROPPED TO TWENTIES, WHICH IS BELOW THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PROGRAMMED LOWER RATE SETTING AND RETURNED TO PACING AT 65 BEATS PER MINUTE (BPM).  IT WAS ALSO REPORTED THAT THE CRT-D INTERROGATION REPORT DISPLAYED QUESTION MARKS INSTEAD OF THE THRESHOLD VALUE WHEN INDICATING A MESSAGE FOR THE FEATURE THAT AUTOMATICALLY MONITIORS PACING THRESHOLDS AT PERIODIC 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 19280947 ↗