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

We found 8 models of Claria MRI CRT-D SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,612 adverse event reports in the FDA's MAUDE database, received between Apr 6, 2017 and Sep 25, 2026 — classified as 34 deaths, 965 injuries, 613 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (263 reports).

5 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 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-1754-2023 · Root cause: Under Investigation by firm · names 2 of these models · 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-1753-2023 · 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. 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 CRT-D SureScan problems

Claria MRI CRT-D SureScan models

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

• Claria MRI™ CRT-D SureScan™ DTMA1D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall7 deaths415 reports
• Claria MRI™ CRT-D SureScan™ DTMA1D4

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall7 deaths409 reports
• Claria MRI™ CRT-D SureScan™ DTMA1D4

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall9 deaths300 reports
• Claria MRI™ CRT-D SureScan™ DTMA1D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall10 deaths269 reports
• Claria MRI™ CRT-D SureScan™ DTMA1D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls63 reports
• Claria MRI™ CRT-D SureScan™ DTMA1D4

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls33 reports
• Claria MRI™ CRT-D SureScan™ DTMA1D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall65 reports
• Claria MRI™ CRT-D SureScan™ DTMA1D4

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 death58 reports

Recent Claria MRI 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.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) patient experienced an infection. The device system was explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50897417 ↗
• MalfunctionSep 24, 2026Pacing Problem

  It was reported that the Right Atrial (RA) lead triggered a warning for undefined high pacing impedance. In addition, the lead exhibited high atrial thresholds. The Implantable Cardioverter Defibrillator (ICD) electrograms (EGM) showed atrial events falling in blanking period with termination of Atrial Tachycardia/Atrial Fibrillation (AT/AF) detected events and inappropriate pacing. 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

  MAUDE report 50885931 ↗
• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an infection and bacteremia. The organism of infection was reported to be enterococcus faecalis. 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 50792029 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Syncope/Fainting

  MAUDE report 50676354 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted and replaced due to bacteremia. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia

  MAUDE report 50500596 ↗
• InjuryAug 14, 2026Premature Discharge of Battery

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) was explanted and replaced due to Premature Battery Depletion. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50261901 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) patient experience an sepsis and bacteremia infection with valvular vegetations. The organism was stated to be enterococcus faecalis and the source of the infection was the tricuspid valve. The device system was explanted.  No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Medical device site infection; Sepsis

  MAUDE report 50256788 ↗
• MalfunctionAug 12, 2026Electromagnetic Interference; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50224344 ↗
• MalfunctionAug 11, 2026Premature Discharge of Battery; Battery Problem

  It was further reported that the CRTD was explanted and replaced.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50211115 ↗
• InjuryAug 11, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation

  It was reported that inappropriate Cardiac Resynchronization Therapy Defibrillator (CRT-D) tracking of Atrial Fibrillation (AF)/Atrial Flutter caused elevated ventricular rates (AF with Rapid Ventricular Response) which led to inappropriate therapy delivery. Shortness of breath was noted. Reprogramming was conducted, and the CRT-D remains in use. The patient is a participant in a clinical study.  No further patient complications have been reported as a result of this event.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Dyspnea; Shock from Patient Lead(s)

  MAUDE report 50201486 ↗
• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by the patient that they experienced ongoing concerns related to Cardiac Resynchronization Therapy Defibrillator (CRT-D) follow-up and cardiac evaluation. The patient reported shortness of breath, dizziness, left-sided pain, leg edema, and difficulty walking, and stated that they had been told they had an obstruction and needed additional workup, including blood testing and an echocardiogram with contrast. The patient also reported that their CareLink monitor was not online and that there were delays and difficulties with follow-up care and referral coordination. The patient expressed frustration that the recommended evaluation and testing had not yet been completed. The CRT-D system remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Ambulation or Postural Difficulties; Dizziness; Dyspnea; Obstruction/Occlusion; Pain; Peripheral Edema

  MAUDE report 50195067 ↗
• MalfunctionAug 6, 2026Electromagnetic Interference; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50159416 ↗
• InjuryAug 5, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the patient received potentially 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 that resulted in termination of Atrial Tachycardia/Atrial Fibrillation (AT/AF) events. 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 50146307 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to infection. Blood cultures tested positive for Staphylococcus epidermidis. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50106197 ↗
• InjuryJul 31, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) was explanted for an unknown reason. The two Left Ventricular (LV) Epicardial leads were capped for an unknown reason. In addition, two Lead Cap kits were attempted and not used 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 50099874 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls