Claria MRI™ CRT-D SureScan™ DTMA1D4 (UDI 00643169929548)Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00643169929548), received between Feb 8, 2018 and Feb 3, 2026 — classified as 1 death, 42 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (16 reports).

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.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 3, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD A PROBLEM WITH THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AWHILE BACK AND THE COMPANY REPRESENTATIVE ADJUSTED IT. 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 24250888 ↗
• MalfunctionOct 23, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEIR BLOOD PRESSURE DROPPED THEY WERE AT PHYSICAL THERAPY. THE PATIENT WAS CONCERNED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT WORKING. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20517342 ↗
• InjuryApr 10, 2024Failure to Deliver Shock/Stimulation; Pacing Problem; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POSSIBLY CLASSIFIED VENTRICULAR TACHYCARDIA (VT) AS SUPRA VENTRICULAR TACHYCARDIA (SVT) AND INAPPROPRIATELY WITHHELD THERAPY OR CLASSIFIED SVT AS VT AND DELIVERED ANTI-TACHYCARDIA PACING. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 19080880 ↗
• InjuryMar 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 INAPPROPRIATE ANTI-TACHYCARDIA PACING AND INAPPROPRIATE HIGH VOLTAGE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AS VENTRICULAR TACHYCARDIA (VT). IT WAS NOTED THAT THE THERAPIES WERE INITIALLY APPROPRIATELY WITHHELD. 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 18986137 ↗
• InjuryNov 16, 2023Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MAY HAVE INAPPROPRIATELY WITHHELD THERAPY FOR A VENTRICULAR ARRHYTHMIA DUE TO THE SUPRA VENTRICULAR TACHYCARDIA (SVT) DISCRIMINATOR FEATURE. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia

  MAUDE report 18152056 ↗
• MalfunctionNov 10, 2023Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE THERAPY DUE TO THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTING SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). 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 18115815 ↗
• InjuryOct 9, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PHYSICIAN THOUGHT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY LONGEVITY WAS LESS 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 17896969 ↗
• InjuryAug 14, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD 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 17547039 ↗
• InjuryJun 8, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TRIGGERED RECOMMENDED REPLACEMENT TIME (RRT) AND NOTED TO BE AT END OF SERVICE (EOS). THE CRT-D WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION. IT WAS ALSO REPORTED THAT THE HIS BUNDLE LEAD OUTPUT WAS HIGH. THE HIS LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17090848 ↗
• InjuryJan 5, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REACHED 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 16103539 ↗
• InjuryAug 19, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXHIBITING QUICKER DEPLETION OF THE BATTERY. THE CLINICIAN ADJUSTED THE EPISODE RECORDING FEATURE AS THEY PRESUMED THIS WAS CONSUMING THE BATTERY. 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 15257267 ↗
• InjuryAug 1, 2022Premature 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 15143207 ↗
• MalfunctionJul 14, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CLINICIAN WAS DISSATISFIED WITH THE PREVIOUS LONGEVITY ESTIMATE 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 15015267 ↗
• InjuryJul 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO INFECTION THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED. THE LV LEAD WAS CAPPED, INACTIVATED AND REMAINS IN THE PATIENT. NO FURTHER PATIENT COMPLICA TIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 14955572 ↗
• DeathApr 7, 2022Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  THE FOLLOWING PHYSICIAN NOTED THAT THERE WERE NO ISSUES WITH THE CRT-D OR ANY CONCERN THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. IT WAS NOTED THAT THE PATIENT MAY HAVE DEVELOPED A SLOW VENTRICULAR TACHYCARDIA (VT) WHICH WAS NOT IN THE TREATMENT ZONE. THE PATIENT'S CAUSE OF DEATH WAS UNKNOWN.

  Patient problems: Tachycardia

  MAUDE report 14047480 ↗
• MalfunctionDec 9, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THERE WAS AN ISSUE WITH THE BIVENTRICULAR FUNCTION OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFI BRILLATOR (CRT-D) AND THE VENTRICULAR LEAD WAS NOT FUNCTIONING RIGHT. THE CRT-D AND 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 12968874 ↗
• InjuryNov 15, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION DUE TO A COMPETITOR LEFT VENTRICULAR (LV) LEAD WITH HIGH PACING OUTPUTS. 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 12813175 ↗
• InjuryJun 29, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REACH ELECTIVE REPLACEMENT INDICATOR (ERI) PREMATURELY DUE TO HIGH LEFT VENTRICULAR (LV) LEAD OUTPUTS. THE DEVICE EXPLANTED AND REPLACED. THE LEAD 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 12089345 ↗
• InjuryJun 28, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) RAPIDLY DEPLETED UNEXPECTEDLY DURING NORMAL USE. 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 12080910 ↗
• InjuryMay 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 11824742 ↗
• InjuryJan 21, 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 INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11207833 ↗
• InjuryNov 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10880270 ↗
• InjuryNov 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INFECTION WAS NOTED TO HAVE DEVELOPED INTO BACTEREMIA/SEPTICEMIA. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AND SHOWED VEGETATION IN THE RIGHT ATRIUM ON THE LEAD. THE PATIENT FURTHER REPORTED POOR DENTITION. IT WAS LATER REPORTED THAT DURING THE EXPLANT PROCEDURE THERE WERE COMPLICATIONS AS A RESULT OF DIFFICULTY EXTRACTING THE COMPETITOR LEFT VENTRICULAR (LV) LEAD WHICH RESULTED IN THE PATIENT'S DEATH.

  Patient problems: Chills; Fever; Sepsis; Unspecified Infection

  MAUDE report 10856435 ↗
• MalfunctionNov 6, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED EARLY BATTERY DEPLETION. IT WAS ADDITIONALLY NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED CHRONICALLY HIGH THRESHOLDS. THE DEVICE AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10801625 ↗
• InjuryNov 4, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED POSSIBLE PREMATURE BATTERY DEPLETION. ADDITIONAL INFORMATION REPORTED THE LEFT VENTRICULAR (LV) LEAD WAS NO LONGER CAPTURING. THE CRT-D WAS EXPLANTED AND REPLACED. THE LV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10786963 ↗