Claria MRI™ CRT-D SureScan™ DTMA1D1 (UDI 00763000059552)Recalls & reported problems

Summary

The FDA's MAUDE database contains 269 adverse event reports that list this exact device (DI 00763000059552), received between Sep 20, 2018 and Sep 8, 2026 — classified as 10 deaths, 162 injuries, 97 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (38 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 269 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Syncope/Fainting

  MAUDE report 50676354 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) patient experience an sepsis and bacteremia infection with valvular vegetations. The organism was stated to be enterococcus faecalis and the source of the infection was the tricuspid valve. The device system was explanted.  No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Medical device site infection; Sepsis

  MAUDE report 50256788 ↗
• MalfunctionMay 21, 2026Electromagnetic Interference; Device Sensing Problem

  IT WAS REPORTED THAT POSSIBLE ELECTROMAGNETIC INTERFERENCE WAS OBSERVED FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TRIGGERING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODE MISCLASSIFICATION. 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 25247073 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED FEVER, INFECTION, AND SEPSIS POSSIBLY DUE TO A URINARY TRACT INFECTION APPROXIMATELY FOUR MONTHS PRIOR TO THE EVENT. THE PATIENT EXPERIENCED AN ADDITIONAL URINARY TRACT INFECTION APPROXIMATELY THREE MONTHS PRIOR TO THE EVENT. ADDITIONALLY, VEGETATION WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. DURING THE EXPLANT OF THE RIGHT VENTRICULAR (RV) LEAD, THE PATIENT SUSTAINED AN INJURY TO THE RIGHT VENTRICLE REQUIRING A STERNOTOMY AND REPAIR. DURING THE EXPLANT OF THE LEFT VENTRICULAR (LV) LEAD, THE PATIENT SUSTAINED AN INJURY TO THE CORONARY SINUS THAT WAS REPAIRED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fever; Sepsis; Unspecified Infection

  MAUDE report 24974798 ↗
• InjuryApr 23, 2026Pacing Problem

  IT WAS REPORTED THAT THERE WAS TROUBLE DETECTING THE PATIENT'S RHYTHM USING AN EXTERNAL MONITOR. IT WAS ALSO NOTED THAT THE PATIENT HAD RECORDED SHORT EPISODES OF ASYSTOLE AND IRREGULAR PACING SPIKES. THE CLINICIAN STATED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IS CAPTURING WHEN IT PACES BUT SUSPECTED THAT THE DEVICE WAS NO PACING CONSISTENTLY OR APPROPRIATELY DESPITE THE PATIENT HAVING A REGULAR PULSE WHEN TAKEN MANUALLY AND BEING ALERT AND RESPONSIVE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole

  MAUDE report 24968215 ↗
• InjuryMar 18, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LIGHT HEADEDNESS AND SYNCOPE. 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: Dizziness; Syncope/Fainting

  MAUDE report 24631833 ↗
• InjuryFeb 19, 2026Defibrillation/Stimulation Problem

  IT WAS FURTHER REPORTED THAT DEVICE WAS REPROGRAMMED, THE ONSET AND STABILITY WERE TURNED OFF. ADDITIONALLY, THE PATIENT WAS HOSPITALIZED, INTUBATED AND INDICATED AS RECOVERING.

  Patient problems: Tachycardia

  MAUDE report 24390305 ↗
• MalfunctionFeb 12, 2026Electromagnetic Interference

  IT WAS REPORTED THAT THERE WAS RIGHT ATRIAL (RA) LEAD OVERSENSING NOTED ON STORED EPISODES RESULTING IN INHIBITION OF PACING AND MIS CLASSIFICATION OF EPISODE TYPE. IT WAS ALSO NOTED THAT THERE WAS POSSIBLE ELECTROMAGNETIC INTERFERENCE. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RA LEAD 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 24329014 ↗
• InjuryJan 28, 2026Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS REPORTED THAT THERAPY WAS INITIALLY INAPPROPRIATELY WITHHELD FOR VENTRICULAR FIBRILLATION (VF) THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT) DUE TO WAVELET. IN ADDITION, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING RESULTING IN T-WAVE OVERSENSING (TWOS). IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED CHEST PAIN. THE CRT-D AND RV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Ventricular Fibrillation

  MAUDE report 24200729 ↗
• MalfunctionJan 26, 2026Failure to Deliver Shock/Stimulation; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED EXTERNAL DEFIBRILLATION BECAUSE THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DID NOT PROPERLY DEFIBRILLATE THEM. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24184806 ↗
• MalfunctionJan 9, 2026Electromagnetic Interference

  IT WAS REPORTED THAT ELECTROMAGNETIC INTERFERENCE WAS NOTED ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR'S (CRT-D) ATRIAL CHANNEL RESULTING IN MISCLASSIFICATION OF EPISODE TYPE. 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 24018853 ↗
• InjuryDec 16, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  FOLLOW UP WITH THE CLINIC INDICATED THAT THE HIGH VOLTAGE THERAPY FOR VF WAS APPROPRIATE. THE PATIENT¿S ANTIARRHYTHMIC DRUG DOSE WAS ADJUSTED, AND ORAL ANTICOAGULANTS WERE RESUMED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23822488 ↗
• InjuryDec 16, 2025Premature 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 23821257 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD STARTED BLACKING OUT AND FALLING AND THEIR HEART RATE HAD DROPPED. THE PATIENT WAS REPORTEDLY SEEN FOR SHORTNESS OF BREATH BY A NURSE PRACTITIONER WHO RAISED THEIR RATE AND THEY WERE ABLE TO TAKE A DEEP BREATH AGAIN. THE PATIENT SAID THEY HAD NO FURTHER SYMPTOMS SINCE. 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: Dyspnea; Fall; Loss of consciousness

  MAUDE report 23567633 ↗
• MalfunctionNov 14, 2025Electromagnetic Interference; Over-Sensing; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED ELECTROMAGNETIC INTERFERENCE WITH NOTED OVERSENSING AND A LEAD INTEGRITY ALERT (LIA) TRIGGERED. 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 23556614 ↗
• InjuryNov 7, 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) PATIENT EXPERIENCED AN INFECTION. THE ORGANISMI WAS SPECIFIED AS METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS AND THE PATIENT ALSO EXPERIENCED BACTEREMIA AND VEGETATION ON THE RIGHT VENTRICULAR (RV) LEAD. THE DEVICE SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection; Unspecified Infection

  MAUDE report 23501587 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. VEGETATION WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD. 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: Medical device site infection

  MAUDE report 23427914 ↗
• InjuryOct 27, 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) PATIENT EXPERIENCED AN SYSTEMIC INFECTION AND WAS HOSPITALIZED. THE DEVICE SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23398157 ↗
• InjuryOct 15, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Appropriate Device Problem Term/Code Not Available; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THE PATIENT EXPERIENCED A HEADACHE AND DURING THE AMBULANCE RIDE THE DEVICE MADE A WEIRD SOUND.

  Patient problems: Headache; Shock from Patient Lead(s)

  MAUDE report 23304163 ↗
• MalfunctionOct 15, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT ATRIAL EVENTS APPEAR TO BE FALLING IN BLANKING AT TIMES POSSIBLY TRIGGERING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AF) DEVICE CLASSIFIED TERMINATION OF AT/AF DETECTED EVENTS, WITH ATRIAL PACING NOTED AT TIMES. 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 23301855 ↗
• MalfunctionJul 29, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT IT WAS QUESTIONED WHY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IS ONLY LASTED THREE YEARS. IT WAS INDICATED THAT THE CRT-D SEEMS TO BE LASTING WHAT WOULD BE EXPECTED BASED UPON GIVEN SETTINGS AND USAGE. 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 22642510 ↗
• InjuryJul 25, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND INTERMITTENT LOSS OF CAPTURE. IT WAS FURTHER REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION AND HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) AND END OF SERVICE (EOS) EARLIER THAN EXPECTED. THE LV LEAD WAS CAPPED AND REPLACED WITH A LEFT BUNDLE BRANCH LEAD AND 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 22609797 ↗
• MalfunctionJul 24, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). THE RA AND RV LEAD WERE REPROGRAMMED AND REMAIN IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588197 ↗
• InjuryJul 22, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKED FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) WHICH THE DEVICE DETECTED AND TREATED AS VENTRICULAR TACHYCARDIA (VT). THE RIGHT VENTRICULAR (RV) LEAD HAD EXHIBITED ELEVATED SENSING INTEGRITY COUNTER (SIC). THE DEVICE AND 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 22565142 ↗
• MalfunctionJul 18, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED BATTERY DEPLETING AT ACCELERATED RATE AND DEVICE DATA REVIEW SHOWED BATTERY DEPLETED TWICE AS FAST AS EXPECTED AND REASON COULD NOT BE IDENTIFIED. NO ACTION WAS TAKEN. THE CRT-D REMAINS WITH MONITORING OF LONGEVITY PROGRESS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22544644 ↗