Claria MRI™ Quad CRT-D SureScan™ DTMA1Q1 (UDI 00763000059590)Recalls & reported problems

Summary

The FDA's MAUDE database contains 213 adverse event reports that list this exact device (DI 00763000059590), received between Feb 8, 2018 and Sep 16, 2026 — classified as 6 deaths, 116 injuries, 91 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (43 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-1755-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 213 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Communication or Transmission Problem

  It was reported by the patient¿s spouse that the past few times the patient was in the hospital, the healthcare professionals would try to send a transmission from the Implantable Cardioverter Defibrillator (ICD) device and it ¿did not work.¿ 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 50792859 ↗
• MalfunctionSep 11, 2026Electromagnetic Interference

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50737366 ↗
• MalfunctionJul 31, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: Dizziness

  MAUDE report 50101835 ↗
• MalfunctionJun 17, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED A POSSIBLE DUAL TACHYCARDIA (SUPRA VE NTRICULAR TACHYCARDIA (SVT) AND VENTRICULAR TACHYCARDIA (VT)) AS ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). IT WAS ADDITIONALLY REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING TRIGGERING ATRIAL TACHYCARDIA (AT)/ ATRIAL FIBRILLATION (AF) MISCLASSIFICATION. THE CRTD 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 25536021 ↗
• MalfunctionMay 21, 2026Electromagnetic Interference; Over-Sensing; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS RESULTING IN UNNECESSARY PACING AT TIMES. ADDITIONALLY, ELECTROMAGNETIC INTERFERENCE WAS OBSERVED ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) LEADING TO RA LEAD OVERSENSING. 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 25249379 ↗
• MalfunctionMay 8, 2026Signal Artifact/Noise; Electromagnetic Interference; Electrical /Electronic Property Problem; Over-Sensing

  IT WAS REPORTED THAT ELECTROGRAM (EGM) MARKERS WITH ATRIAL FIBRILLATION (AF) EVIDENCE WERE NOTED FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). FURTHER REVIEW REVEALED ATRIAL LEAD POSITION CHECK VERBIAGE AND AF NOTED ON THE AT-AR EGM AS WAS AS CAN - RIGHT VENTRICULAR (RV) COIL (RVC). ATRIAL OVERSENSING AND NOISE WERE CONFIRMED. OTHER RECORDED EPISODES AND CURRENT EGM SHOW NORMAL CHANNEL MARKERS WITH NO ATRIAL ACTIVITY NOTED ON CAN>RVC EGM. THE PATIENT WAS TESTED IN CLINIC WITH NO REPRODUCIBLE SYMPTOMS. THE PATIENT'S HUSBAND PROVIDED THE DAYS AND TIMES OF THE EPISODES ARE CONSISTENT WITH WHEN THE PATIENT DOES PHYSICAL THERAPY FOR STROKE, THE HUSBAND EXPLAINED THE PHYSICAL THERAPY SESSIONS AS, THEY HAVE HER RIDE ON THIS BIKE AND THERE IS AN APPARATUS HOOKED UP. THE PATIENT'S HEALTHCARE PROFESSIONAL (HCP) CONFIRMED THE PATIENT USES A RESTORATIVE THERAPIES, INC. BIKE THAT USES FUNCTIONAL ELECTRICAL STIMULATION (RTI FES). THE PATIENT HAD BEEN USING THE THERAPY BIKE FOR 30 MINUTES TWO TIMES PER WEEK FOR MONTHS. ELECTROMAGNETIC INTERFERENCE WAS CONFIRMED. THE PATIENT WILL STOP USING THE THERAPY BIKE. THE CRT-D REMAINS IN USE. NO PATIENT COMPLICATIONS HAV E BEEN REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25124393 ↗
• DeathMay 1, 2026Failure to Charge; Electrical /Electronic Property Problem; Delayed Charge Time

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) IN CARDIAC ARREST. REVIEW OF THE REMOTE TRANSMISSION SHOWED RIGHT VENTRICULAR (RV) LEAD UNDERSENSING AND LOSS OF CAPTURE. THE RIGHT ATRIAL (RA) LEAD HAD UNDEFINED HIGH IMPEDANCE AND EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENTS IN PROGRESS AND UNNECESSARY PACING. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TRIGGERED A CHARGE CIRCUIT TIMEOUT AND CHARGE CIRCUIT INACTIVE AND HAD A LONG CHARGE TIME AT RECOMMENDED REPLACEMENT TIME (RRT). IT WAS NOTED THAT THE RRT OCCURRED ALMOST SEVEN WEEKS PRIOR. THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Cardiac Arrest

  MAUDE report 25059837 ↗
• InjuryApr 30, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A SHOCK AND ANTI-TACHYCARDIA PACING (ATP) FOR AN EPISODE DETECTED A EPISODE IN THE VENTRICULAR FIBRILLATION (VF) ZONE THAT WAS SUSPECTED TO BE 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 25053251 ↗
• InjuryMar 25, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THERAPY WAS INITIALLY WITHHELD FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) DUE TO WAVELET FOR AN EPISODE IN THE FAST VENTRICULAR TACHYCARDIA (VT) ZONE.  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 24688915 ↗
• InjuryMar 17, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA (AT)/ATRIAL FIBRILLATION (AF) EVENTS RESULTING IN INAPPROPRIATE ATRIAL PACING. IN ADDITION, THE PATIENT RECEIVED A SHOCK AND ANTI-TACHYCARDIA PACING (ATP) DUE TO THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MIS-DETECTING AT/AF WITH RAPID VENTRICULAR RESPONSE (RVR) AS VENTRICULAR FIBRILLATION (VF). THE LEAD AND DEVICE 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 24617247 ↗
• MalfunctionMar 12, 2026Pacing Problem

  IT WAS REPORTED BY THE HEALTH CARE PROFESSIONAL (HCP) THAT THE LOWER RATE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS SET AT SIXTY BEATS PER MINUTE (BPM), HOWEVER THERE WERE PERIODS OF TIME WHERE THE PATIENT'S PULSE WAS BELOW THAT RATE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 24584876 ↗
• MalfunctionMar 12, 2026Impedance Problem

  IT WAS REPORTED THAT THERE WAS ALERT TONING FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND IT WAS INQUIRED WHE THER THE ALERT WAS RELATED TO AN OUT OF RANGE SVC IMPEDANCE RELATED TO A RECENTLY IMPLANTED COMPETITOR LEAD AS DEVICE DIAGNOSTICS SHOWED ERRATIC SVC IMPEDANCE MEASUREMENTS. A CONNECTION ISSUE INVOLVING THE SVC PATHWAY WAS SUSPECTED BUT NOT CONFIRMED. 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 24584026 ↗
• MalfunctionMar 6, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED UNEXPECTED BATTERY LONGEVITY AS THERE WAS A LARGE DROP IN VOLTAGE AROUND THE TIME THE LONGEVITY DROPPED. 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 24537643 ↗
• InjuryFeb 24, 2026Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD PASSED OUT AND WERE ADMITTED TO THE HOSPITAL WITH VENTRICULAR TACHYCARDIA (VT). THEY WERE TOLD THEIR DEFIBRILLATION THERAPY SENSITIVITY WAS SET LOW AND IT HAD NOW BEEN INCREASED. 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: Syncope/Fainting; Tachycardia

  MAUDE report 24431401 ↗
• InjuryFeb 17, 2026Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT DURING A HIP REVISION PROCEDURE THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY SECONDARY TO USE OF CAUTERY AND INAPPROPRIATE PLACEMENT OF A MAGNET OVER THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). 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 24368582 ↗
• MalfunctionJan 26, 2026Pacing Problem

  IT WAS REPORTED THAT ATRIAL EVENTS WERE FALLING IN THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR'S (CRT-D) BLANKING PERIOD RES ULTING IN TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS AND INAPPROPRIATE ATRIAL PACING AT TIMES. 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 24178900 ↗
• InjuryDec 2, 2025Failure to Charge; Failure to Charge

  IT WAS REPORTED THAT THERE WAS HIGH PACING, DEFIBRILLATION, AND SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE, A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED EPISODES AND IMPEDANCE VARIATIONS, AND A NOISE WARNING ON THE RIGHT VENTRICULAR (RV) LEAD. A CHARGE CIRCUIT TIMEOUT OCCURRED ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE LEAD AND DEVICE REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Sepsis

  MAUDE report 23692775 ↗
• InjuryNov 19, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD CHRONIC HIGH THRESHOLDS AND THE LEFT VENTRICULAR (LV) LEAD ALSO EXHIBITED HIGH THRESHOLDS. THE LV LEAD HAD ONLY ONE VIABLE VECTOR CONFIGURATION. IT WAS REPORTED THAT BOTH THE RV AND LV LEADS DEVELOPED EXIT BLOCK OVER THE YEARS. THE RV AND LV LEADS ARE STILL IN USE BASED ON DECISION MADE BY THE PHYSICIAN AND PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23600286 ↗
• InjuryNov 12, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT REVIEW OF A REMOTE TRANSMISSION SHOWED ANTI-TACHYCARDIA PACING (ATP) AND HIGH-VOLTAGE THERAPIES WERE DELIVERED FOR EPISODES THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF) ZONES, HOWEVER IT WAS SUSPECTED THAT THERAPIES MAY HAVE BEEN INAPPROPRIATE FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) AS THERE WAS AN ATRIAL ARRHYTHMIA IN PROGRESS AT THE TIME OF THERAPIES. 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 23534567 ↗
• InjuryNov 4, 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 VEGETATION IN THE RIGHT ATRIUM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23466943 ↗
• MalfunctionAug 22, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED EPISODE OF VENTRICULAR FIBRILLATION (VF) TREATED WITH ANTI-TACHYCARDIA PACING (ATP) WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS AT TIMES AND POTENTIAL MISCLASSIFICATION OF EVENT AS VENTRICULAR TACHYCARDIA (VT). 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 22874477 ↗
• InjuryAug 21, 2025Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Battery Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR CONDUCTED ATRIAL FIBRILLATION (AF)/ SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE DEVICE DETECTED AS VENTRICULAR FIBRILLATION (VF). THE CRT-D WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22862909 ↗
• InjuryAug 13, 2025Defibrillation/Stimulation Problem; Device Sensing Problem; Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS REPORTED THAT DURING THE PATIENT'S SLOW VENTRICULAR TACHYCARDIA (VT), THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD WITHHELD THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT). IN ADDITION, THERE WAS UNDERSENSING ON THE RIGHT ATRIAL (RA) LEAD. THE DEVICE AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 22795025 ↗
• InjuryAug 4, 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 A SYSTEMIC BACTEREMIA INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 22703067 ↗
• InjuryJul 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) PATIENT HAD EXPERIENCED A STROKE OR SEIZURE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Convulsion/Seizure; Stroke/CVA

  MAUDE report 22569302 ↗