Claria MRI™ Quad CRT-D SureScan™ DTMA1Q1 (UDI 00643169837669)Recalls & reported problems

Summary

The FDA's MAUDE database contains 289 adverse event reports that list this exact device (DI 00643169837669), received between Jun 12, 2018 and Sep 23, 2026 — classified as 7 deaths, 153 injuries, 129 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (65 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 289 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Premature Discharge of Battery

  It was reported that the Left Ventricular (LV) lead "thresholds "[were]" leading to increased battery drain" from the Cardiac Resynchronization Therapy Defibrillator (CRT-D). The lead was reprogrammed, and the lead and the device 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 50873460 ↗
• MalfunctionMar 11, 2026Pacing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXHIBITING OCCASIONAL INAPPROPRIATE ATRIAL PACING. 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 24570217 ↗
• MalfunctionMar 10, 2026Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE EXHIBITED ELECTROMAGNETIC INTERFERENCE RESULTING IN ATRIAL OVERSENSING THAT LEAD TO MISCLASSIFICATION OF EPISODE TYPE. 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 24560797 ↗
• InjuryMar 2, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THE PATIENT UNDERWENT VENTRICULAR TACHYCARDIA (VT) ABLATION.

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

  MAUDE report 24484998 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS WARM. THE HEALTHCARE PROFESSIONAL IS HAVING LABS DRAWN TO ASSESS FOR INFECTION. THE HEALTHCARE PROFESSIONAL STATES THE DEVICE FEELS WARM COMPARED TO THE OTHER SIDE OF CHEST. THE DEVICE REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE PATIENT FEELS HOT INSIDE THE CRT-D POCKET. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH THE DEVICE POCKET AREA RED AND SWOLLEN INDICATIVE OF CELLULITIS. THE PATIENT WAS TREATED WITH TWO ROUNDS OF ANTIBIOTICS GIVEN EMBOLIC INFECTION TO THE CRT-D POCKET REGION. THE FLUID UNDER THE CRT-D AREA FELT HOT. BLOOD CULTURES WERE POSITIVE FOR C-REACTIVE PROTEIN. 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; Blood Protein Abnormal; Cellulitis; Erythema; Inflammation; Medical device site infection

  MAUDE report 23649166 ↗
• InjuryNov 18, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23586890 ↗
• MalfunctionNov 7, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED BY THE PATIENT TO BE IN ATRIAL FIBRILLATION (AF) FOR ABOUT A WEEK, SENT A MANUAL TRANSMISSION AND THE ON CALL TECHNICIAN LOOKED AT THE TRANSMISSION.  ADDITIONALLY, THE PATIENT STATED, HAS HEARD THE ALARM FOR ABOUT FIVE SECONDS AND WAS TOLD BY THE PHYSICIAN TO CONTACT CARELINK TRANSMISSION SUPPORT BECAUSE THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IS TRYING TO COMMUNICATE BUT IS NOT GOING THROUGH.  THE CRT-D REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation

  MAUDE report 23497346 ↗
• InjuryNov 3, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE EXPERIENCED 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 23458074 ↗
• InjurySep 10, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE CRT-D WAS EXPLANTED AND REPLACED AS A STANDARD ELECTIVE REPLACEMENT INDICATOR (ERI) GENERATOR CHANGEOUT. "NON-PROPHYLACTIC" WAS MISTAKENLY CHECKED ON THE PAPERWORK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017436 ↗
• InjuryAug 26, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED FOR AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22896069 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A METH ICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 22708417 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A CARDIAC TRANSPLANTATION. IT WAS NOTED THAT THERE WAS SOME SUSPICION PREOPERATIVELY THAT THE PATIENT HAD LEAD RELATED ENDOCARDITIS. IT WAS REPORTED THAT PORTIONS OF THE RIGHT VENTRICULAR (RV) LEAD AND CORONARY SINUSLEFT VENTRICULAR (LV) LEAD HAD SOME THROMBUS OR VEGETATION ON THEM. THE ENTIRE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; Medical device site infection

  MAUDE report 22649660 ↗
• MalfunctionJul 22, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH BRADYCARDIA, DIZZINESS AND NEAR SYNCOPE. A DEVICE INTERROGATION INDICATED OVERSENSING ON THE RIGHT ATRIAL (RA) LEAD. IT WAS REPORTED BY THE PATIENT'S SPOUSE THE FOLLOWING DAY THAT THE PATIENT'S HEART RATE WAS GOING DOWN TO FORTY BEATS PER MINUTE. THE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PROGRAMMED TO A LOWER RATE OF SIXTY BEATS PER MINUTE. THE RA LEAD AND CRT-D REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 22566995 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN UNSPECIFIED INFECTION. IT WAS STATED THAT THE PATIENT WAS GOING TO GO THROUGH A SYSTEM EXTRACTION DUE TO THE INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND THE RIGHT VENTRICULAR (RV) LEAD WERE REPLACED. THE LEFT VENTRICULAR (LV) LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22470609 ↗
• InjuryJul 7, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS WHICH RESULTED IN PREMATURE BATTERY DEPLETION. THE LEAD WAS EXPLANTED AND REPLACED. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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 22411504 ↗
• MalfunctionMay 16, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PATIENT PRESENTED TO THE EMERGENCY ROOM AND WAS FEELING DIZZY. A HEART MONITOR SHOWED A BRADYCARDIC HEART RATE IN THE THIRTY AND FORTY BEATS PER MINUTE RANGE. IT WAS NOTED THAT THE PATIENT WAS PROGRAMMED TO A LOWER RATE OF SIXTY BEATS PER MINUTE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Dizziness

  MAUDE report 22034217 ↗
• InjuryMar 17, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE HIGH VOLTAGE THERAPY AND ANTI-TACHYCARDIA PACING FOR SUSPECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS 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 21620801 ↗
• MalfunctionFeb 13, 2025Mechanical Problem; Misconnection; Mechanical Problem; Misconnection

  IT WAS REPORTED THAT DURING A GENERATOR CHANGEOUT PROCEDURE, THE LEFT VENTRICULAR (LV) LEAD WAS STUCK IN THE HEADER OF THE EXISTING CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PORT. REMOVING THE SET SCREW, APPLYING MINERAL OIL, FLUSHING WITH SALINE, AND USING FORCE WERE UNSUCCESSFUL AT REMOVING THE LV LEAD FROM THE CRTD PORT. THE PATIENT REPORTED THAT A GRINDER WAS USED TO REMOVE THE SET SCREW. ULTIMATELY, THE LV LEAD WAS REMOVED FROM THE PORT AND SUCCESSFULLY CONNECTED TO THE REPLACEMENT CRTD AFTER TESTING NORMALLY. THE CRTD WAS ELECTIVELY REPLACED AND THE LV 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 21379360 ↗
• InjuryFeb 3, 2025Premature 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 21300045 ↗
• InjuryDec 27, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION, AND THE LEFT VENTRICULAR (LV) LEAD THRESHOLDS WERE HIGH. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE LV LEAD WAS REPROGRAMMED AND LATER CAPPED AND REPLACED WITH A NEW LV LEAD IN A DIFFERENT BRANCH. IT WAS ALSO REPORTED THAT WHEN PREPPING FOR THE REPLACEMENT PROCEDURE THEY WERE UNABLE TO MAKE ANY PROGRAMMING CHANGES TO THE LV LEAD PACE POLARITY AS THE DEVICE HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21030592 ↗
• InjuryDec 13, 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 DUE TO METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS BACTEREMIA. A WEEK LATER, THE SYSTEM WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 20929483 ↗
• MalfunctionNov 18, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE CHECK DUE TO ELEVATED HEART RATE.  THE PHYSICIAN REPORTED THE DEVICE/CRT-D WAS MALFUNCTIONING.  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 20708098 ↗
• InjuryNov 7, 2024Mechanical Problem; Misconnection; Mechanical Problem; Misconnection

  IT WAS REPORTED THAT DURING A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CHANGEOUT PROCEDURE, THE RIGHT ATRIAL (RA) LEAD COULD NOT BE REMOVED FROM THE CRT-D HEADER DESPITE MULTIPLE ATTEMPTS WITH THE WRENCH TO UNSCREW THE SET SCREW. FINALLY, THE WRENCH ENGAGED, AND THE SET SCREW WAS COMPLETELY REMOVED; HOWEVER, THE LEAD REMAINED STUCK IN THE HEADER. AN RA LEAD WAS NOT NECESSARY FOR THE PATIENT, SO THE LEAD WAS CUT TO FREE IT FROM THE DEVICE AND WAS PARTIALLY EXPLANTED AND NOT REPLACED. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD AN INSULATION BREACH AND THERE WAS ¿OLD¿ BLOOD IN THE LEAD. THE LEAD WAS CAPPED AND REPLACED. 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 20636648 ↗
• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. VEGETATION WAS NOTED ON THE LEADS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. EIGHT DAYS LATER THE DEVICE SYSTEM WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20632006 ↗
• MalfunctionOct 29, 2024Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR CAPTURE MANAGEMENT WAS POTENTIALLY CAUSING VENTRICULAR TACHYCARDIA (VT). THE CARDIAC RESY NCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 20559906 ↗