Claria MRI™ CRT-D SureScan™ DTMA1D1 (UDI 00643169929531)Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00643169929531), received between Feb 8, 2018 and Jul 14, 2025 — classified as 41 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (11 reports).

1 FDA recall record name this device's identifier.

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. 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 ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• InjuryJul 14, 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 INFECTION AND EROSION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 22501338 ↗
• MalfunctionJun 6, 2025Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) COULD NOT BE INTERROGATED TO EVALUATE THE PATIENT. 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 22156921 ↗
• MalfunctionMay 13, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE PATIENT THAT WHEN THEY WOKE UP, IT FELT LIKE THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD MOVED IN THEIR CHEST. 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 22009787 ↗
• MalfunctionJan 3, 2025Electromagnetic Interference; Over-Sensing; Communication or Transmission Problem; Electromagnetic Interference; Over-Sensing; Communication or Transmission Problem

  IT WAS REPORTED THAT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR OVERSEN SING HIGH-RATE, NON-SUSTAINED EPISODES AND SHORT VENTRICULAR INTERVALS DUE TO EXTERNAL ELECTROMAGNETIC INTERFERENCE CONFIRMED BY THE CALLER. ADDITIONALLY, IT WAS NOTED THAT THE IMPEDANCE MEASUREMENT WAS NOT TAKEN POSSIBLY DUE TO INTERMITTENT TELEMETRY. 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 21069758 ↗
• InjuryFeb 8, 2024Adverse 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 AND REPLACED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18672443 ↗
• InjuryDec 5, 2023Battery Problem; Battery Problem

  IT WAS REPORTED THAT THE PHYSICIAN QUESTIONED THE LONGEVITY OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). 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 18267129 ↗
• InjuryAug 25, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT A MAGNET WAS PLACED OVER THE HOSPICE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND WAS SECURED IN PLACE HOWEVER THE PATIENT'S FAMILY NOTED THAT THE MAGNET WAS NOT WORKING AND THE PATIENT WAS RECEIVING UNWANTED SHOCKS FROM THE DEVICE. THE DEVICE IS 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 17625433 ↗
• InjuryMay 23, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK DURING SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). IN ADDITION, THERE WERE MULTIPLE LEAD WARNINGS SINCE 2018 FOR SENSING INTEGRITY COUNTER (SIC) AND NOISE, AND HIGH/UNDEFINED AND VARIABLE PACING IMPEDANCE MEASUREMENTS. THE RIGHT VENTRICULAR (RV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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 16984685 ↗
• InjuryMar 20, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION AND REACHED RECOMMENDED REPLACEMENT TIME (RRT) EARLIER 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 16573860 ↗
• MalfunctionJan 19, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEEN IN-CLINIC AND THE CRT-D WAS INTERROGATED. THE INTERROGATION INDICATED THAT THE DEVICE WAS FUNCTIONING APPROPRIATELY AND NO HEART RATE EVENTS WERE OBSERVED LESS THAN 40 BEATS PER MINUTE.

  Patient problems: Bradycardia

  MAUDE report 16203295 ↗
• InjuryNov 1, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS EXPERIENCING INTERMITTENT LOSS OF CAPTURE, INCREASED CAPTURE, AND VARIABLE CAPTURE. IT WAS NOTED THAT THE PATIENT WAS EXPERIENCING CONGESTIVE HEART FAILURE TYPE SYMPTOMS. FURTHER INFORMATION RECEIVED IDENTIFIED LOWER EXTREMITY EDEMA, SHORTNESS OF BREATH, FULLNESS IN CHEST, MILD COUGH, AND INTERMITTENT EPISODES OF RACING HEARTBEATS AS THE CONGESTIVE HEART FAILURE TYPE SYMPTOMS THE PATIENT WAS EXPERIENCING. IT WAS ALSO NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED REDUCED LONGEVITY DUE TO HIGH THRESHOLD MEASUREMENTS OF THE LV LEAD. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15712559 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A POCKET REVISION WAS PERFORMED BECAUSE THE PATIENT WAS EXPERIENCING PAIN AT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IMPLANT SITE. DURING THE POCKET REVISION, REPROGRAMMING WAS DONE TO ADJUST THE LEFT VENTRICULAR (LV) LEAD PULSE WIDTH. AFTER THE PROCEDURE, THE PATIENT EXPERIENCED A DROP IN EJECTION FRACTION AND THE PHYSICIAN REPORTED THAT THE DEVICE WAS NOT WORKING. IT WAS DETERMINED THAT THE LV LEAD EXHIBITED A LOSS OF CAPTURE WAS DUE TO THE REPROGRAMMING DONE DURING THE POCKET REVISION. THE CRT-D AND THE LV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 15520101 ↗
• InjuryMay 9, 2022Adverse 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, SPECIFICALLY VEGETATION. A NEW SYSTEM WAS IMPLANTED SEVERAL DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 14338337 ↗
• InjuryApr 22, 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 14190192 ↗
• MalfunctionFeb 2, 2022Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A HEART RATE IN THE TWENTY BEATS PER MINUTE RANGE WITH NO EVIDENCE OF PACING SPIKES ON AN ELECTROCARDIOGRAM. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOTED TO BE PROGRAMMED TO A LOWER PACING RATE OF FORTY BEATS PER MINUTE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 13424195 ↗
• InjuryJan 12, 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 13236762 ↗
• InjuryDec 14, 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) WAS EXPLANTED AND REPLACED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 13001827 ↗
• InjuryOct 13, 2021Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A POSSIBLE INAPPROPRIATE SHOCK FOR ATRIAL ARRHYTHMIA WITH RAPID VENTRICULAR RESPONSE DETECTED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AS VENTRICULAR FIBRILLATION (VF). THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING. THE DEVICE AND 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 12623242 ↗
• MalfunctionMay 7, 2021Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY WAS DEPLETING PREMATURELY. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING THRESHOLDS. NO ACTION WAS TAKEN, THE PATIENT IS TO BE MONITORED REMOTELY, AND 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 11790108 ↗
• InjuryMay 5, 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 INFECTED. THE CRT-D WAS REMOVED AND USED TO PACE THE PATIENT EXTERNALLY. THE SYSTEM LEADS WERE CUT AND CAPPED. THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11778414 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A SYSTEMIC INFECTION, THE LEFT VENTRICULAR (LV) EPICARDIAL LEAD WAS CAPPED AND THE REMAINING CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11553094 ↗
• InjuryNov 18, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT FELT INTERMITTENT WARMTH FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE INCISION AND POCKET SHOWED NO REDNESS OR SWELLING AND ALL DEVICE MEASUREMENTS WERE NORMAL. IT WAS FURTHER REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE DEVICE POCKET. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 10864225 ↗
• InjuryNov 4, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS LATER REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAS BEEN EXPLANTED AND REPLACED, AS PLANNED.

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

  MAUDE report 10787889 ↗
• InjuryOct 19, 2020Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DID NOT MEET LONGEVITY EXPECTATIONS. 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; No Consequences Or Impact To Patient

  MAUDE report 10700355 ↗
• InjuryOct 16, 2020Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A PARTIAL ELECTRICAL RESET. THE CRT-D WAS RE-INTERROGATED, AND REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10690434 ↗