Claria MRI™ Quad CRT-D SureScan™ DTMA1QQ (UDI 00763000059514)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,243 adverse event reports that list this exact device (DI 00763000059514), received between Apr 3, 2018 and Sep 29, 2026 — classified as 35 deaths, 845 injuries, 363 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (262 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-1756-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,243 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted 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 50936715 ↗
• MalfunctionSep 25, 2026Electromagnetic Interference

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902432 ↗
• InjurySep 23, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that, during review of a patient transmission, the Cardiac Resynchronization Therapy Defibrillator (CRT-D) appeared to undersense atrial activity during a ventricular fibrillation episode, which may have contributed to inappropriate therapy delivery. It was further reported that the Right Atrial (RA) lead exhibited undersensing and diminished P waves. The CRT-D and RA lead remain in use. No further patient complications have been reported as a result of this event.

  Patient problems: Ventricular Fibrillation

  MAUDE report 50873915 ↗
• MalfunctionSep 23, 2026Premature Discharge of Battery

  It was reported that the Right Ventricular (RV) lead exhibited oversensing resulting in pacing inhibition. The RV lead triggered a Lead Integrity Alert (LIA) due to elevated Sensing Integrity Counter (SIC) and pacing impedance variation. Additionally, noise was present on RV lead channels. The patient was experiencing dizziness and was hospitalized. The RV lead was capped and replaced. No further patient complications have been reported as a result of this event. It was further reported that, prior to the lead revision, the RV lead had also exhibited high thresholds. It was also reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) exhibited an unexpected drop in battery longevity estimate. The CRT-D remains in use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868023 ↗
• InjurySep 15, 2026Premature 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 50778365 ↗
• MalfunctionSep 15, 2026Electromagnetic Interference; Under-Sensing

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) experienced Electromagnetic Interference which caused atrial lead undersensing that resulted in misclassification of episode detection. 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 50777140 ↗
• InjurySep 15, 2026Insufficient Device Problem Information

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was removed for unknown reasons. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771866 ↗
• MalfunctionSep 14, 2026Device Sensing Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) detected Ventricular Tachycardia (VT) monitored and non-sustained episodes for possible dual arrhythmia episodes that may have been Atrial Fibrillation (AF) with Rapid Ventricular Response episodes. Additionally, the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) resulting in unnecessary pacing at times and pretermination of AT/AF events in progress. The 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 50756177 ↗
• InjurySep 10, 2026Pacing 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 Ventricular Fibrillation (VF). The Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) that resulted in termination of AT/AF detected events and unnecessary atrial pacing. The patient also experienced phrenic nerve stimulation from the Left Ventricular (LV) lead. The LV lead was reprogrammed. The RA lead, LV lead, and CRT-D 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 50718085 ↗
• InjurySep 10, 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 an infection with Endocarditis. No further patient complications have been reported as a result of this event.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 50716841 ↗
• InjurySep 4, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50618289 ↗
• MalfunctionSep 3, 2026Device Sensing Problem

  It was further reported that there was a confirmed issue with device detection/episode classification in that there was undersensing of P-waves. The patient expired approximately one week post-report after a brief illness. No further information was reported or could be obtained.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50594690 ↗
• InjuryAug 28, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the patient inquired about functionality of the heart device, as the patient was experiencing irregular heartbeat issues again.  Additionally, the patient mentioned having a machine at home that indicates the heart condition and expressed concern about whether the defibrillator was working properly.   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: Insufficient Information

  MAUDE report 50502872 ↗
• MalfunctionAug 24, 2026Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50416102 ↗
• InjuryAug 12, 2026Premature Discharge of Battery

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) exhibited premature battery depletion. Additionally, it was noted that the Right Atrial (RA) lead and Left Ventricular (LV) lead exhibited high thresholds. The CRT-D was explanted and replaced and the RA lead and LV 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 50223643 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an infection with fever and redness. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted and subsequently replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Erythema; Fever; Unspecified Infection

  MAUDE report 50211665 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Medical device site infection

  MAUDE report 50074808 ↗
• MalfunctionJul 27, 2026Electromagnetic Interference; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50037464 ↗
• InjuryJul 10, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND A SHOCK FOR AN EPISODE OF SUPRA V ENTRICULAR TACHYCARDIA (SVT) DETECTED AS VENTRICULAR TACHYCARDIA (VT). 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 25787268 ↗
• MalfunctionJun 24, 2026Device Sensing Problem

  IT WAS REPORTED THAT RIGHT ATRIAL (RA) LEAD UNDERSENSING WAS OBSERVED RESULTING IN FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES. IT WAS ALSO NOTED THAT RA LEAD UNDERSENSING MAY HAVE CONTRIBUTED TO THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MISCLASSIFICATION OF SOME ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) EPISODES AS MONITORED-VENTRICULAR TACHYCARDIA (VT) AND NON-SUSTAINED VT. THE RA LEAD AND CRT-D 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 25613269 ↗
• MalfunctionJun 19, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THERE WAS FUNCTIONAL UNDERSENSING IN THE REFRACTORY/BLANKING PERIOD THAT RESULTED IN OVERPACING. IN ADDITION, S TORED EPISODES REVEALED OVERSENSING AND UNDERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. THERE WAS AN OBSERVATION FOR A FAILED RIGHT ATRIAL (RA) LEAD POSITION CHECK. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEADS REMAIN IN USE. NO PATIENT CO MPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25560509 ↗
• InjuryJun 15, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS FOR A DETECTED VENTRICULAR FIBRILLATION (VF) THAT WAS SUSPECTED TO BE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE CRTD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25511373 ↗
• MalfunctionJun 9, 2026Electromagnetic Interference

  IT WAS REPORTED THAT A RIGHT VENTRICULAR (RV) LEAD INTEGRITY ALERT (LIA) DUE TO ELECTROMAGNETIC INTERFERENCE THAT WAS DETECTED BY 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 25445784 ↗
• MalfunctionJun 8, 2026Pacing Problem

  IT WAS REPORTED THAT THERE WERE ATRIAL EVENTS FALLING IN THE BLANKING PERIOD TRIGGERING DEVICE CLASSIFIED TERMINATION OF ATRIAL TACH YCARDIA/ATRIAL FIBRILLATION (AT/AF) DETECTED EVENTS AND RESULTING IN UNNECESSARY PACING AT TIMES. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 25429825 ↗
• InjuryJun 3, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WITHHELD THERAPY FOR A VENTRICULAR TACHYCARDIA (VT) EPISODE DUE TO THE SINUS TACHYCARDIA RULE. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 25379214 ↗