Claria MRI™ CRT-D SureScan™ DTMA1D4 (UDI 00763000059583)Recalls & reported problems

Summary

The FDA's MAUDE database contains 300 adverse event reports that list this exact device (DI 00763000059583), received between May 15, 2018 and Sep 24, 2026 — classified as 9 deaths, 193 injuries, 98 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (47 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-1754-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 300 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Pacing Problem

  It was reported that the Right Atrial (RA) lead triggered a warning for undefined high pacing impedance. In addition, the lead exhibited high atrial thresholds. The Implantable Cardioverter Defibrillator (ICD) electrograms (EGM) showed atrial events falling in blanking period with termination of Atrial Tachycardia/Atrial Fibrillation (AT/AF) detected events and inappropriate pacing. The lead and device 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 50885931 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an infection and bacteremia. The organism of infection was reported to be enterococcus faecalis. 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: Bacteremia; Unspecified Infection

  MAUDE report 50792029 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted and replaced due to bacteremia. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia

  MAUDE report 50500596 ↗
• InjuryAug 14, 2026Premature 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 50261901 ↗
• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by the patient that they experienced ongoing concerns related to Cardiac Resynchronization Therapy Defibrillator (CRT-D) follow-up and cardiac evaluation. The patient reported shortness of breath, dizziness, left-sided pain, leg edema, and difficulty walking, and stated that they had been told they had an obstruction and needed additional workup, including blood testing and an echocardiogram with contrast. The patient also reported that their CareLink monitor was not online and that there were delays and difficulties with follow-up care and referral coordination. The patient expressed frustration that the recommended evaluation and testing had not yet been completed. The CRT-D system remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Ambulation or Postural Difficulties; Dizziness; Dyspnea; Obstruction/Occlusion; Pain; Peripheral Edema

  MAUDE report 50195067 ↗
• InjuryAug 5, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the patient received potentially inappropriate Anti-Tachycardia Pacing (ATP) and high voltage therapy from the Cardiac Resynchronization Therapy Defibrillator (CRT-D) for Atrial Fibrillation (AF) with rapid ventricular response that was detected as Ventricular Fibrillation (VF). The Right Atrial (RA) lead exhibited undersensing that resulted in termination of Atrial Tachycardia/Atrial Fibrillation (AT/AF) events. The CRT-D 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 50146307 ↗
• InjuryJul 31, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) was explanted for an unknown reason. The two Left Ventricular (LV) Epicardial leads were capped for an unknown reason. In addition, two Lead Cap kits were attempted and not used for an unknown reason. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50099874 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to infection with bacteremia. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 50037277 ↗
• InjuryJun 25, 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 SHOCK FOR AN EPISODE DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) ZONE. IT WAS NOTED THAT ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH FAST VENTRICULAR RESPONSE WAS IN PROGRESS AT THE TIME OF THE TREATED VT EPISODE. 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 25623170 ↗
• DeathJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION WITH EROSION AND PURULENT DISCHARGE OBSERVED. DURING THE ATTEMPTED EXPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM, THE PATIENT EXPIRED DURING EXTRACTION OF THE RIGHT ATRIAL (RA) LEAD. IT WAS NOTED THAT THE OTHER TWO LEADS WERE SUCCESSFULLY REMOVED, HOWEVER THE RA LEAD CAUSED A COMPLICATION. IT WAS NOTED THAT DURING RIGHT ATRIAL LEAD EXTRACTION, IT WAS PERCEIVED THAT A PERFORATION WAS CREATED WHEN THE ATRIAL LEAD WAS REMOVED.

  Patient problems: Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 25459733 ↗
• InjuryMar 10, 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 HIGH VOLTAGE THERAPY FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH FAST VENTRICULAR RESPONSE THAT WAS DETECTED 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 24560764 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD AN INFECTION GROWING ON ONE OF THEIR LEADS. 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: Unspecified Infection

  MAUDE report 24445794 ↗
• MalfunctionFeb 13, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AN EPISODE OF SUPRA VENTRICULAR TACHYCARDIA (SVT) AS NON-SUSTAINED VENTRICULAR TACHYCARDIA. ADDITIONALLY, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE CRT-D AND RV 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 24336355 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE RA LEAD WAS DISLODGED.

  Patient problems: Dyspnea

  MAUDE report 24259645 ↗
• MalfunctionFeb 3, 2026Electromagnetic Interference

  IT WAS REPORTED THAT THERE WAS A SINGLE SPIKE ACROSS ALL ELECTROGRAMS (EGM) ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THAT LOOKED LIKE AN EXTERNAL SOURCE. THE SPIKE APPEARED TO HAVE BEEN SENSED ON THE ATRIAL CHANNEL. 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 24246730 ↗
• InjuryFeb 2, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 24235144 ↗
• MalfunctionJan 15, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE A TRANSMISSION WAS UNABLE TO BE OBTAINED FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). 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 24083105 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION WITH VEGETATION NOTED ON THE LEADS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND A REPLACEMENT WAS IMPLANTED ONE WEEK LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 24068680 ↗
• MalfunctionJan 7, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED PREMATURE BATTERY DEPLETION. 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 23993317 ↗
• InjuryDec 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE SYSTEM HAD BEEN EXPLANTED DUE TO A SECONDARY INFECTION FROM A GANGRENOUS FOOT.

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

  MAUDE report 23916080 ↗
• InjuryDec 9, 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 POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED AS FAST VENTRICULAR TACHYCARDIA (FVT). THE PATIENT EXPERIENCED DIZZINESS/NEAR SYNCOPE. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Presyncope; Shock from Patient Lead(s)

  MAUDE report 23759187 ↗
• InjuryDec 2, 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) SYSTEM WAS REMOVED DUE TO METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS ENDOCARDITIS. A LEADLESS PACEMAKER WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Endocarditis

  MAUDE report 23697176 ↗
• InjuryNov 4, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE EXPERIENCED 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 23464775 ↗
• InjuryOct 30, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE EPICARDIAL LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND WAS NOT BENEFITING THE PATIENT. IT WAS ALSO REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED EARLY ELECTIVE REPLACEMENT INDICATOR (ERI) DUE TO THE HIGH LV OUTPUTS. THE LV LEAD WAS CAPPED AND THE CRT-D WAS EXPLANTED AND REPLACED WITH AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430221 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE SYSTEM WAS EXTRACTED DUE TO INFECTION.

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

  MAUDE report 23386205 ↗