Claria MRI™ Quad CRT-D SureScan™ DTMA1QQ (UDI 00643169543362)Recalls & reported problems

Summary

The FDA's MAUDE database contains 116 adverse event reports that list this exact device (DI 00643169543362), received between Apr 6, 2017 and Jan 7, 2026 — classified as 4 deaths, 66 injuries, 46 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (16 reports).

4 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. Apr 12, 2017Class IITerminated

   An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad CRT-D MRI devices.

   Z-2117-2017 · Root cause: Software design · Recall details · FDA record ↗

4. 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 116 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT IN (B)(6) 2025 THE REMAINING LONGEVITY FOR THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS 13 MONTHS. THE DEVICE HAS NOW PREMATURELY REACHED END OF SERVICE (EOS). THE DEVICE HAS BEEN 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 23995770 ↗
• InjuryDec 2, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING RESULTING IN PREMATURE TERMINATION OF DETECTED ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES. ADDITIONALLY, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED THERAPY FOR A DETECTED VENTRICULAR TACHYCARDIA (VT) EPISODE. IT WAS NOTED THAT THE CRT-D INITIALLY WITHHELD THERAPY DUE TO THE AF/ATRIAL FLUTTER DISCRIMINATOR, BUT THE VT EPISODE WAS RECLASSIFIED AS A DUAL TACHYCARDIA AND THERAPY WAS DELIVERED. IT WAS RECOMMENDED TO DISCUSS THE FINDINGS WITH THE PHYSICIAN TO DETERMINE IF THE TREATED VT EPISODE WAS AF WITH RAPID VENTRICULAR RESPONSE OR VT. THE CRT-D AND RA 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 23698257 ↗
• 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 BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia

  MAUDE report 21885567 ↗
• InjuryMar 19, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND HIGH-VOLTAGE THERAPY FOR AN ARRHYTHMIA DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE, HOWEVER THE RHYTHM MAY HAVE BEEN ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE DEVICE 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 21646324 ↗
• MalfunctionOct 28, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO FATIGUE.  THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. A LITTLE OVER A MONTH LATER, IT WAS FURTHER REPORTED THAT THE CRT-D EXHIBITED AN POSSIBLE UNSPECIFIED PROBLEM. IT WAS ALSO NOTED THAT THE PATIENT WAS EXPERIENCING CONTINUED GENERALIZED WEAKNESS. ABOUT A WEEK LATER, THE CRT-D WAS EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION.

  Patient problems: Fatigue; Muscle Weakness/Atrophy

  MAUDE report 20549530 ↗
• InjuryMar 30, 2024Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT HAD OPEN HEART SURGERY FOLLOWED BY ANOTHER OPEN HEART SURGERY APPROXIMATELY TWO WEEKS LATER. THERE WERE MANY STORED EPISODES OF NOISE AND OVERSENSING NOTED DURING THE PROCEDURES, POSSIBLY DUE TO CAUTERY. DURING THE MOST RECENT OPEN HEART SURGERY, INAPPROPRIATE HIGH VOLTAGE THERAPY WAS DELIVERED DUE TO OVERSENSING AND A LEAD INTEGRITY ALERT (LIA) WAS ALSO NOTED TO BE TRIGGERED DUE TO THE CAUTERY WHICH INDUCED NOISE AND OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 19008980 ↗
• MalfunctionMar 21, 2024Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED A DECREASE IN P WAVE AMPLITUDES. THE RA LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MAY HAVE MISCLASSIFIED AN EPISODE AS SUPRA VENTRICULAR TACHYCARDIA (SVT) DUE TO THE DEVICE DISCRIMINATORS. 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 18953387 ↗
• InjuryFeb 15, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PACEMAKER MEDIATED TACHYCARDIA FOLLOWING RETROGRADE CONDUCTION. IT WAS NOTED THERE WAS ALSO INTERMITTENT FAR FIELD R-WAVE (FFRW) OVERSENSING ON THE RIGHT ATRIAL (RA) LEAD. THE DEVICE AND LEAD WERE REPROGRAMMED AND REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia

  MAUDE report 18714097 ↗
• InjuryJan 5, 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 REMOVED DUE TO INFECTION. THE PHYSICIAN ALSO NOTED VEGETATION. SIX DAYS LATER, THE CRT-D SYSTEM WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18460139 ↗
• MalfunctionNov 14, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXHIBITING ABNORMAL BATTERY DEPLETION. THE DEVICE REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18131450 ↗
• InjuryOct 11, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  UPON FURTHER REVIEW, IT DOES APPEAR THAT BASED ON EVENT CONTEXT AND INFORMATION THIS EVENT SHOULD NOT HAVE BEEN REPORTED. THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY OR THAT THE DEVICE HAS MALFUNCTIONED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 17911590 ↗
• MalfunctionAug 25, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT REPORTED TO THE EMERGENCY DEPARTMENT DUE TO SHORTNESS OF BREATH. IT WAS NOTED BY THE PATIENT'S FAMILY THAT THE PATIENT'S HOME MONITOR WAS SAYING THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT WORKING PROPERLY. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 17623977 ↗
• MalfunctionJul 25, 2023Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT HEART RATES OF 38-40 BEATS PER MINUTE WERE OBSERVED ON A CARDIAC MONITOR. THIS WAS LOWER THAN THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PROGRAMMED LOWER RATE. A MANUAL MEASUREMENT OF THE HEART RATE WAS NOT PERFORMED. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 17388908 ↗
• DeathApr 17, 2023Failure to Deliver Shock/Stimulation; Failure to Deliver Shock/Stimulation

  ADDITIONAL INFORMATION WAS OBTAINED AND IT WAS NOTED THAT THE PATIENT'S CAUSE OF DEATH WAS HYPERTENSION AND ATHEROSCLEROTIC CARDIOVASCULAR DISEASE.

  Patient problems: Arteriosclerosis/ Atherosclerosis; High Blood Pressure/ Hypertension; Insufficient Information

  MAUDE report 16752351 ↗
• MalfunctionFeb 17, 2023Pacing Problem; Pacing Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS EXPERIENCING FREQUENT PREMATURE VENTRICULAR CONTRACTIONS (PVC).

  Patient problems: Bradycardia

  MAUDE report 16400347 ↗
• InjuryJan 24, 2023Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DISCRIMINATORS INITIALLY WITHHELD VENTRICULAR TACHYCARDIA (VT)/VENTRICULAR FIBRILLATION (VF) DETECTION AND THERAPY. THE HEALTHCARE PROFESSIONAL REPORTED THE PATIENT WAS CURRENTLY IN SUSTAINED VT WITH NO THERAPY. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 16231764 ↗
• MalfunctionJan 19, 2023Failure to Interrogate; Failure to Interrogate

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) COULD NOT BE INTERROGATED BY THE REMOTE MONITOR AT THE CLINIC. 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 16207068 ↗
• MalfunctionDec 28, 2022Data Problem; Data Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A POSSIBLE BATTERY ISSUE. THE REMOTE MONITOR DISPLAYED A 8225 DIAGNOSTIC CODE INDICATING THE DEVICE WAS NOT AFFILIATED WITH THE ASSIGNED MONITOR IN THE REMOTE MONITORING NETWORK. TROUBLESHOOTING STEPS WERE TAKEN WITH THE MONITOR TO NO AVAIL. THE MONITOR WAS REPLACED. 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 16061686 ↗
• MalfunctionDec 6, 2022Device Sensing Problem; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT IS EXPECTED TO COME INTO THE CLINIC FOR REPROGRAMMING BUT THE REPROGRAMMING HAS NOT YET BEEN COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15925170 ↗
• InjuryDec 1, 2022Appropriate 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 DUE TO AN UNSPECIFIED PERFORMANCE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15894364 ↗
• MalfunctionOct 27, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT WAS FEELING SHORTNESS OF BREATH AND FELT LIKE THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT WORKING ANYMORE.  THE DEVICE REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dyspnea

  MAUDE report 15682048 ↗
• InjuryJul 25, 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 EXPLANTED DUE TO AN INFECTION ON THE LEADS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15096043 ↗
• MalfunctionJul 20, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THEY HAVE A DAMAGED THIRD LEAD WHICH IS DRAWING THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY MUCH MORE RAPIDLY THAN IT IS SUPPOSED TO. THE PATIENT NOTED THAT THEY HEARD TONES FROM THEIR DEVICE WHICH WERE THEN TURNED OFF BY THE PHYSICIAN HOWEVER NOTED THAT SEVERAL DAYS LATER THEY STARTED TO GET VERY DIZZY. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 15068258 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED DUE TO INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 14940379 ↗
• InjuryJun 15, 2022Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE PATIENT RECEIVED SEVERAL HIGH VOLTAGE THERAPY SHOCKS THAT APPEARED TO BE DUE TO SUPRA VENTRICULAR TACHYCARDIA (SVT). REVIEW OF DEVICE DATA INDICATED THE PATIENT RECEIVED HIGH VOLTAGE THERAPY SHOCK DUE TO THE RHYTHM EXCEEDED SVT LIMIT. IT WAS NOTED THAT THE FEATURE THAT MONITORS INAPPROPRIATE VENTRICULAR DETECTION IF THE RHYTHM DISPLAYS CHARACTERISTICS OF AN SVT ORIGIN INITIALLY APPROPRIATELY WITHHELD HIGH VOLTAGE SHOCK THERAPY. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT MORPHOLOGY INTERMITTENTLY CHANGED FROM SVT-ST EPISODES AND A SINGLE PEAKED EPISODE REMINISCENT OF A VENTRICULAR TACHYCARDIA (VT). 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 14694556 ↗