Claria MRI™ Quad CRT-D SureScan™ DTMA1QQ (UDI 00643169720633)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,479 adverse event reports that list this exact device (DI 00643169720633), received between Apr 10, 2018 and Sep 29, 2026 — classified as 22 deaths, 992 injuries, 465 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (248 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 1,479 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Electromagnetic Interference

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941134 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Fall; Presyncope; Syncope/Fainting

  MAUDE report 50763434 ↗
• MalfunctionSep 14, 2026Electromagnetic Interference; Over-Sensing; Impedance Problem

  It was reported that a device nurse indicated that the patient experienced electrical interference while using a meat grinder that was not properly grounded, leading to concerns about oversensing on the Cardiac Resynchronization Therapy Defibrillator (CRT-D) ventricular lead.  Information received indicted that due to Electromagnetic Interference (EMI) a Lead Integrity Alert (LIA) triggered for High Rate-non sustained episodes, Sensing Integrity Counter (SIC) (Short V-V Intervals) and RV bipolar Lead Impedance.  The CRT-D remains in use.  It was also reported that the Right Atrial (RA) lead exhibited atrial lead position check failed.  The RA 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 50753480 ↗
• InjuryAug 21, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that there was a Lead Integrity Alert (LIA) triggered due to high Sensing Integrity Counter (SIC) with High-Rate Non-Sustained episodes, along with Right Ventricular (RV) lead oversensing while the patient was undergoing shoulder surgery resulting in misclassification of episode type. It was further reported that the patient was inappropriately shocked and experienced shoulder pain. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) and RV lead remain in use. No further patient complications have been reported as a result of this event.

  Patient problems: Pain; Shock from Patient Lead(s)

  MAUDE report 50380100 ↗
• MalfunctionAug 10, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50196739 ↗
• MalfunctionJul 13, 2026Unauthorized Access to Computer System

  Patient problems: Chest Pain; Tachycardia

  MAUDE report 25798716 ↗
• MalfunctionJul 8, 2026Pacing Problem

  IT WAS REPORTED THAT THE CALLER WAS QUESTIONING A VENTRICULAR SENSING EPISODE WITH EXTENDED ATRIOVENTRICULAR (AV) INTERVALS. AV INTERVALS WERE NOT REACHING THE UPPER RATE LIMIT. 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 25753113 ↗
• MalfunctionJun 26, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED POSSIBLE OVERSENSING. IT WAS FURTHER REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED VENTRICULAR SENSING EPISODE OF RV OVERSENSING WHICH WAS SUGGESTIVE OF NOISE WERE DEEM RELATED TO SURGERY. THE DEVICE AND 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 25636622 ↗
• InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BACTEREMIA INFECTION. 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 25566296 ↗
• InjuryJun 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A GENERATOR CHANGE. THE IMPLANT SITE APPEARED PUFFY AND SOFT. UPON OPENING THE POCKET, THE PHYSICIAN OBSERVED PUS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS REMOVED AND THE PATIENT'S THREE LEADS WERE CAPPED DUE TO THE POSSIBLE INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 25534874 ↗
• InjuryJun 11, 2026Battery Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION ON MULTIPLE VECTORS FROM THE LEFT VENTRICULAR (LV) LEAD. ADDITIONALLY, IT WAS NOTED THAT THE LV LEAD EXHIBITED UNSTABLE THRESHOLDS AND HIGH THRESHOLDS. IT WAS NOTED THAT THE HIGH THRESHOLDS WERE DRAINING THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY "FAST." THE CRT-D AND LV LEAD WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25473877 ↗
• MalfunctionMay 29, 2026Pacing Problem

  IT WAS REPORTED THAT THE PATIENT ¿FELT HORRIBLE¿ AND TELEMETRY SHOWED A HEART RATE OF FIFTEEN BEATS-PER-MINUTE WHICH IS BELOW THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PROGRAMMED LOWER RATE SETTING. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 25334775 ↗
• MalfunctionMay 22, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FOR DIZZINESS AND NEAR SYNCOPE. A TRANSMISSION REPORT WAS REVIEWED AND IT WAS NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POSSIBLY CLASSIFIED AN EPISODE OF ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE AS VENTRICULAR TACHYCARDIA (VT). ADDITIONALLY, IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENTS IN PROGRESS AND UNNECESSARY PACING AT TIMES. IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. THE CRT-D AND BOTH LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260479 ↗
• MalfunctionMay 12, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT HAD COMPLAINTS ABOUT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE NOT WORKING AND THEY EXPERIENCED SHORTNESS OF BREATH. IT WAS FURTHER REPORTED THAT THE DEVICE REACHED RECOMMENDED REPLACEMENT TIME (RRT). THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 25153936 ↗
• DeathApr 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS INTERMITTENT RIGHT VENTRICULAR (RV) LEAD UNDERSENSING OBSERVED ON STORED EPISODES. YEARS LATER IT WAS REPORTED THAT THE PATIENT WAS FOUND UNRESPONSIVE. EMERGENCY MEDICAL SERVICES (EMS) PROVIDED CARDIOPULMONARY RESUSCITATION (CPR) AND TWO EXTERNAL SHOCKS TO THE PATIENT. UPON REVIEW THERE WAS ADDITIONAL UNDERSENSING AND OVERSENSING OBSERVED ON THE RV LEAD. VENTRICULAR TACHYCARDIA (VT) THERAPIES WERE NOT PREVIOUSLY PROGRAMMED ON AND WERE PROGRAMMED ON FOLLOWING THE EVENT. THE PATIENT DIED TWO DAYS LATER. IT WAS FURTHER REPORTED THAT SYSTEM PERFORMANCE WAS NOT THOUGHT TO HAVE CONTRIBUTED TO THE PATIENT'S DEATH, HOWEVER CAUSE OF DEATH WAS NOTED TO BE SEPSIS AND CARDIAC ARREST. THE SOURCE OF THE INFECTION WAS REQUESTED BUT WAS UNKNOWN.

  Patient problems: Cardiac Arrest; Sepsis

  MAUDE report 24944037 ↗
• MalfunctionMar 30, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. THE DOCTOR NOTED THAT THE BATTERY PERFORMANCE WAS "NOT VERY GOOD FROM THE START." IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS. 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 24731096 ↗
• InjuryMar 30, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY A FRIEND OF THE PATIENT THAT THE PATIENT HAD ¿A COUPLE OF SHOCKS, ACCIDENTAL¿ AND FELT A TINGLE WHEN THE PATIENT HAD A SHOCK. 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 24719261 ↗
• MalfunctionFeb 24, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POSSIBLY MISCLASSIFIED A VENTRICULAR TACHYCARDIA (VT) EPISODE AS SUPRA VENTRICULAR TACHYCARDIA (SVT). ADDITIONALLY, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED POSSIBLY UNDERSENSING. 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 24433528 ↗
• MalfunctionFeb 13, 2026Electrical /Electronic Property Problem

  THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO REACHING ELECTIVE REPLACEMENT INDICATOR (ERI) AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335913 ↗
• InjuryFeb 4, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING THERAPY AND MULTIPLE SHOCKS FOR AN EPISODE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). 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 24261218 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH SEPSIS. THE ORGANISM OF INFECTION WAS REPORTED TO BE STAPHYLOCOCCUS AUREUS. THE PATIENT ALSO EXPERIENCED A FEVER. 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: Bacterial Infection; Sepsis; Unspecified Infection

  MAUDE report 24223294 ↗
• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO EROSION AND INFECTION WITH PURULENT DISCHARGE/PUS. IT WAS NOTED THAT DURING THE REMOVAL OF THE RIGHT ATRIAL (RA) LEAD, THE LEAD SNAPPED OFF IN THE BODY, SO THAT LEAD WAS PARTIALLY REMOVED.. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 24202223 ↗
• InjuryJan 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND THEN REPLACED TWO WEEKS LATER DUE TO INFECTION AND REDNESS. THE SOURCE OF THE INFECTION WAS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Unspecified Infection

  MAUDE report 24152603 ↗
• MalfunctionJan 20, 2026Reset Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED A FULL ELECTRICAL RESET. 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 24124986 ↗
• InjuryJan 20, 2026Battery Problem

  IT WAS FURTHER REPORTED THAT THE CRT-D WAS EXPLANTED AND REPLACED. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121630 ↗