Claria MRI™ CRT-D SureScan™ DTMA1D1 (UDI 00643169705777)Recalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00643169705777), received between Apr 6, 2017 and Aug 12, 2026 — classified as 33 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (12 reports).

3 FDA recall records 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. Feb 3, 2021Class IOpen, Classified

   A small percentage of implanted cardiac devices, from a well-defined subset, may experience a shortened Recommended Replacement Time (RRT) to End of Service (EOS) interval following an earlier-than-expected RRT observation

   Z-1306-2021 · Root cause: Device Design · Recall details · FDA record ↗

2. Dec 19, 2017Class ITerminated

   Possible prevention of high and low voltage therapy in Medtronic Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillator (CRT-D).

   Z-0586-2018 · Root cause: Process design · Recall details · FDA record ↗

3. Dec 9, 2016Class IITerminated

   During internal testing conducted as part of next generation product development, it was discovered that the AdaptivCRT (aCRT) feature of Amplia MRI and Claria MRI CRT -D devices may appear to be enabled when it is not active.

   Z-0962-2017 · Root cause: Software Design Change · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Electromagnetic Interference; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50224344 ↗
• InjuryDec 16, 2025Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SUPRA VENTRICULAR TACHYCARDIA (SVT) DISCRIMINATOR INAPP ROPRIATELY WITHHELD VENTRICULAR TACHYCARDIA (VT) THERAPY AFTER CLASSIFYING THE ARRHYTHMIA AS SVT-ATRIAL FIBRILLATION (AF). THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 23815904 ↗
• MalfunctionAug 13, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED ANTI-TACHYCARDIA PACING (ATP) FOR POSSIBLE SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED 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 22795623 ↗
• InjuryApr 22, 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 EXPLANTED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21884005 ↗
• InjuryFeb 10, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DUE TO SIGNIFICANT DISCOMFORT REPORTED BY THE PATIENT, A POCKET REVISION WAS PERFORMED DURING A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXCHANGE DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 21347015 ↗
• MalfunctionOct 31, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DURING USE OF THE RIGHT VENTRICULAR (RV) LEAD, THE PATIENT EXPERIENCED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) DUE TO T-WAVE OVERSENSING (TWOS). A RECENT REMOTE TRANSMISSION SHOWED OTHER NOTED TWOS EPISODES PROPERLY WITHHOLDING THERAPY VIA THE DISCRIMINATION ALGORITHM. A REVIEW OF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE DATA SHOWED THAT RV LEAD INTERMITTENT TWOS CAUSED THE TWOS DISCRIMINATOR TO STOP WITHHOLDING. NO ACTION TAKEN. THE RV 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 20577623 ↗
• MalfunctionAug 6, 2024Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE 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: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19923833 ↗
• MalfunctionMay 3, 2024Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE PATIENT HAD AN ENDOSCOPIC PROCEDURE AND APPROXIMATELY TWO WEEKS LATER, ANOTHER PROCEDURE. THE TRANSMISSIONS WERE REVIEWED AND ELECTROMAGNETIC INTERFERENCE (EMI) WAS NOTED ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AT THE TIMES OF THE PROCEDURES. THE DEVICE APPEARED TO BE UNDERSENSING AND OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD AND OVERSENSING ON THE RIGHT ATRIAL (RA) LEAD BECAUSE OF THE EMI. ON THE DAY OF THE SECOND PROCEDURE, A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED FOR HIGH RATE NON-SUSTAINED EPISODES AND SHORT VENTRICULAR TO VENTRICULAR INTERVALS DUE TO THE EMI. 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 19240384 ↗
• InjuryFeb 9, 2024Misconnection; Misconnection

  IT WAS REPORTED THAT DURING A DEVICE CHANGE OUT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE LEFT VENTRICULAR (LV) LEAD COULD NOT BE REMOVED FROM THE HEADER CONNECTOR. THE GROMMET WAS REMOVED TO BETTER VISUALIZE THE SETSCREW AND THE LV PIN COULD BE SEEN THROUGH THE CONNECTOR BLOCK SETSCREW BORE. THE LV LEAD COULD NOT BE ROTATED NOR PUSHED IN OR PULLED OUT. THE LV LEAD WAS SUCCESSFULLY REMOVED FROM THE DEVICE AND REMAINS IN USE WITH THE NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18681495 ↗
• InjuryDec 14, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED 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 18330255 ↗
• InjuryNov 20, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS POSSIBLY SHOCKED FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AS VENTRICULAR TACHYCARDIA (VT). THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED DECREASING R-WAVES AND UNDERSENSING. THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING AND CHRONIC LOSS OF CAPTURE. THE CRT-D AND LEADS 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 18176506 ↗
• MalfunctionAug 15, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A DEVICE CHANGEOUT FOR NORMAL BATTERY DEPLETION, THERE WAS A STRIPPED SETSCREW THAT COULD NOT BE REMOVED. THE SETSCREW WAS REMOVED USING A HEMOSTAT, 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 17550141 ↗
• InjuryJul 27, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT WAS POSSIBLY INAPPROPRIATELY SHOCKED FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE CARDIAC RESYN CHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD WAS UNDERSENSING. THE DEVICE AND LEAD ARE STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 17408327 ↗
• MalfunctionJul 24, 2023Electromagnetic Interference; Over-Sensing; Impedance Problem; Electromagnetic Interference; Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT THE PATIENT HAD EXERTIONAL FATIGUE AND SHORTNESS OF BREATH. IT WAS FOUND THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A LEAD INTEGRITY ALERT (LIA) TRIGGERED BY SENSING INTEGRITY COUNTER (SIC), AND RV PACING IMPEDANCE VARIATION. IT WAS FURTHER NOTED THAT THERE WAS RV OVERSENSING. IT WAS ALSO REPORTED THAT THE EPISODES COUNTERS WERE OFF ON THE REPORTS ON THE NETWORK. IT WAS FURTHER REPORTED FROM FOLLOW UP WITH THE CLINIC THAT THE PATIENT HAD BEEN USING ELECTRICAL TOOLS WHICH CAUSED A SHORT PERIOD OF ELECTROMAGNETIC INTERFERENCE (EMI) WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE EMI ON THE DEVICE RESULTED IN THE VENTRICULAR OVERSENSING AND TRIGGERED THE LIA FOR SIC AND PACING IMPEDANCE VARIATION THAT WAS OBSERVED ON THE RV CHANNEL. FOLLOW UP WITH THE CLINIC INDICATED THAT NO INTERVENTION WAS NEEDED, AND THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea; Fatigue

  MAUDE report 17385575 ↗
• MalfunctionJun 20, 2023Pacing Problem; Data Problem; Pacing Problem; Data Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA, AS NOTED ON EXTERNAL TELEMETRY, WHICH WAS BELOW THE LOWER PROGRAMMED RATE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE PATIENT NOTED THAT THE CRT-D BATTERY WAS "NOT GOOD". THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON THE PRESENTING ELECTROGRAMS (EGM). THE CRT-D AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 17167410 ↗
• MalfunctionFeb 27, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THERE WERE INAPPROPRIATE SPIKES ON QRS. 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 16445810 ↗
• InjuryOct 20, 2022Failure to Deliver Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THERE WAS SUSPECTED POTENTIAL INAPPROPRIATE THERAPY ON TREATED VENTRICULAR TACHYCARDIA (VT) ZONE EPISODES. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED CHRONICALLY LOW R WAVES. THE CRT-D AND RV 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 15640036 ↗
• InjuryOct 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT CALLED TO REPORT BEING DISSATISFIED. THE PATIENT REPORTED CONTINUALLY BEING AWARE OF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BECAUSE IT PRESSES UNCOMFORTABLY AGAINST THE PATIENT¿S SKIN. THE PATIENT CLAIMED THERE IS A VERY POINTED CORNER THAT IS CAUSING PAIN. THE PATIENT ASSUMED IT WAS IMPLANTED UPSIDE DOWN AND MENTIONED THE SKIN IS WHITE AS A RESULT OF THE PRESSURE. IT WAS FURTHER REPORTED THAT THE CRT-D WAS EXPLANTED AND REPLACED WITH A COMPETITOR PRODUCT DUE TO THE PAIN THE PATIENT WAS EXPERIENCING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 15615492 ↗
• InjuryAug 11, 2022Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT, DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) "I HAD A SHOCK LAST YEAR.  MY HEART RATE WAS NORMAL." PATIENT INQUIRED THE REASONING FOR THE SHOCK AND WHETHER A PROGRAMMING ERROR CAN CAUSE SHOCK.  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 15210957 ↗
• InjuryJul 19, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED RAPID 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 15055156 ↗
• InjuryMay 6, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED 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 14307808 ↗
• MalfunctionFeb 22, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY WAS NOT GOING TO LAST AS LONG AS THEY WERE TOLD IT WOULD. 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 13577316 ↗
• InjuryFeb 8, 2022Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED AN INAPPROPRIATE SHOCK DUE TO ELECTROMAGNETIC INTERFERENCE (EMI) WHILE THE PATIENT WAS IN THE SHOWER. IT WAS NOTED THAT THE PATIENT HAD THEIR FURNACE SERVICED ON THE SAME DAY THEY RECEIVED THE SHOCK. 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 13481977 ↗
• InjuryDec 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POCKET EROSION AND AN INFECTION WERE NOTED. 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: Pocket Erosion; Unspecified Infection

  MAUDE report 13046820 ↗
• InjuryDec 20, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). 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 13043543 ↗