Claria MRI Quad CRT-D SureScanRecalls & reported problems across all models

We found 8 models of Claria MRI Quad CRT-D SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 3,644 adverse event reports in the FDA's MAUDE database, received between Apr 6, 2017 and Sep 29, 2026 — classified as 82 deaths, 2,371 injuries, 1,191 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (627 reports).

6 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Claria MRI Quad CRT-D SureScan recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-1756-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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 · names 2 of these models · Recall details · FDA record ↗

3. 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 · names 2 of these models · Recall details · FDA record ↗

4. 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 · names 3 of these models · Recall details · FDA record ↗

5. 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 ↗

6. 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 · names 2 of these models · Recall details · FDA record ↗

Most reported Claria MRI Quad CRT-D SureScan problems

Claria MRI Quad CRT-D SureScan models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Claria MRI™ Quad CRT-D SureScan™ DTMA1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  22 deaths1,479 reports
• Claria MRI™ Quad CRT-D SureScan™ DTMA1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall35 deaths1,243 reports
• Claria MRI™ Quad CRT-D SureScan™ DTMA1Q1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall7 deaths289 reports
• Claria MRI™ Quad CRT-D SureScan™ DTMA1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 recalls4 deaths116 reports
• Claria MRI™ Quad CRT-D SureScan™ DTMA1Q1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall6 deaths213 reports
• Claria MRI™ Quad CRT-D SureScan™ DTMA1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall5 deaths194 reports
• Claria MRI™ Quad CRT-D SureScan™ DTMA1Q1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls51 reports
• Claria MRI™ Quad CRT-D SureScan™ DTMA1Q1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 deaths59 reports

Recent Claria MRI Quad CRT-D SureScan adverse event reports

The 15 most recent reports across all models, 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 29, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted 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 50936715 ↗
• MalfunctionSep 25, 2026Electromagnetic Interference

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902432 ↗
• InjurySep 23, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that, during review of a patient transmission, the Cardiac Resynchronization Therapy Defibrillator (CRT-D) appeared to undersense atrial activity during a ventricular fibrillation episode, which may have contributed to inappropriate therapy delivery. It was further reported that the Right Atrial (RA) lead exhibited undersensing and diminished P waves. The CRT-D and RA lead remain in use. No further patient complications have been reported as a result of this event.

  Patient problems: Ventricular Fibrillation

  MAUDE report 50873915 ↗
• 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 ↗
• MalfunctionSep 23, 2026Premature Discharge of Battery

  It was reported that the Right Ventricular (RV) lead exhibited oversensing resulting in pacing inhibition. The RV lead triggered a Lead Integrity Alert (LIA) due to elevated Sensing Integrity Counter (SIC) and pacing impedance variation. Additionally, noise was present on RV lead channels. The patient was experiencing dizziness and was hospitalized. The RV lead was capped and replaced. No further patient complications have been reported as a result of this event. It was further reported that, prior to the lead revision, the RV lead had also exhibited high thresholds. It was also reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) exhibited an unexpected drop in battery longevity estimate. The CRT-D remains in use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868023 ↗
• 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 ↗
• InjurySep 15, 2026Premature Discharge of Battery

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) exhibited 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 50778365 ↗
• MalfunctionSep 15, 2026Electromagnetic Interference; Under-Sensing

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) experienced Electromagnetic Interference which caused atrial lead undersensing that resulted in misclassification of episode detection. 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 50777140 ↗
• InjurySep 15, 2026Insufficient Device Problem Information

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was removed for unknown reasons. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771866 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Fall; Presyncope; Syncope/Fainting

  MAUDE report 50763434 ↗
• MalfunctionSep 14, 2026Device Sensing Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) detected Ventricular Tachycardia (VT) monitored and non-sustained episodes for possible dual arrhythmia episodes that may have been Atrial Fibrillation (AF) with Rapid Ventricular Response episodes. Additionally, the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) resulting in unnecessary pacing at times and pretermination of AT/AF events in progress. 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 50756177 ↗
• 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 ↗
• MalfunctionSep 11, 2026Electromagnetic Interference

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50737366 ↗
• InjurySep 10, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the patient received possible inappropriate Anti-Tachycardia Pacing (ATP) and high voltage therapy from the Cardiac Resynchronization Therapy Defibrillator (CRT-D) for Atrial Fibrillation (AF) with rapid ventricular response that was detected as Ventricular Fibrillation (VF). The Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) that resulted in termination of AT/AF detected events and unnecessary atrial pacing. The patient also experienced phrenic nerve stimulation from the Left Ventricular (LV) lead. The LV lead was reprogrammed. The RA lead, LV lead, and 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 50718085 ↗

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