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

We found 8 models of Amplia MRI CRT-D SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 631 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Sep 29, 2026 — classified as 14 deaths, 368 injuries, 249 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (118 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

Amplia 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-1762-2023 · 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-1761-2023 · 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-0582-2018 · Root cause: Process design · names 2 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 Amplia MRI CRT-D SureScan problems

Amplia MRI CRT-D SureScan models

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

• Amplia MRI™ CRT-D SureScan™ DTMB1D4

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls4 deaths122 reports
• Amplia MRI™ CRT-D SureScan™ DTMB1D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls1 death85 reports
• Amplia MRI™ CRT-D SureScan™ DTMB1D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall3 deaths114 reports
• Amplia MRI™ CRT-D SureScan™ DTMB1D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall1 death82 reports
• Amplia MRI™ CRT-D SureScan™ DTMB1D4

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall4 deaths82 reports
• Amplia MRI™ CRT-D SureScan™ DTMB1D4

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall1 death75 reports
• Amplia MRI™ CRT-D SureScan™ DTMB1D4

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  53 reports
• Amplia MRI™ CRT-D SureScan™ DTMB1D1

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

Recent Amplia 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 29, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937443 ↗
• DeathSep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by the patients representative that the patient implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) system "had a sepsis infection from "[the]" defibrillator ports" and "there was an infection on the lead from "[the]" defibrillator". The patient¿s representative reported the patient was "put on antibiotics instead of replacing as usually done". The patient expired approximately 8 weeks later.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 50883708 ↗
• MalfunctionAug 6, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161416 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND SUBSEQUENTLY REPLACED DUE TO AN INFECTION. IT WAS NOTED THAT THE POCKET WAS THE SUSPECTED SOURCE OF THE INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25668763 ↗
• MalfunctionMay 27, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS UNABLE TO BE INTERROGATED. 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 25303451 ↗
• MalfunctionMay 20, 2026Signal Artifact/Noise; Electromagnetic Interference

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS, A DECREASE IN R-WAVES, AND INCREASE IN PACING IMPEDANCE. A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED FOR HIGH-RATE NON-SUSTAINED EPISODES AND PACING IMPEDANCE VARIATION. THE LEAD HAD A SUSPECTED RVRING FRACTURE AND TACHYARRHYTHMIA DETECTIONS WERE TURNED OFF. THERE WAS ELECTROMAGNETIC INTERFERENCE/NOISE ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TRIGGERING EPISODE MISCLASSIFICATION AS ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). THE RV 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 25234700 ↗
• InjuryApr 17, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. IT WAS ALSO NOTED THAT THERE WAS A COMPETITOR LEAD WITH HIGH THRESHOLDS, HIGH IMPEDANCE, AND A PROBABLE FRACTURE. 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 24912955 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A DEVICE POCKET INFECTION WITH DISCOMFORT, REDNESS, AND SWELLING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Swelling/ Edema; Unspecified Infection

  MAUDE report 24874419 ↗
• InjuryFeb 24, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT AN ICD BUT A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D).

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24433595 ↗
• InjuryFeb 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION. THE INFECTION WAS DETERMINED TO BE METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS AND THE PATIENT WAS GIVEN VANCOMYCIN. THE PATIENT EXPERIENCED A WOUND OVER THE DEVICE SITE WITH DISCHARGE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT A LEADLESS PACEMAKER WAS IMPLANTED 4 DAYS LATER AND THE PATIENT HAD BEEN IN BRADYCARDIA SINCE EXPLANT.

  Patient problems: Bradycardia; Drug Resistant Bacterial Infection; Fluid Discharge; Medical device site infection; Wound Dehiscence

  MAUDE report 24349182 ↗
• InjuryFeb 6, 2026Failure to Deliver Shock/Stimulation; Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THERAPY WAS POTENTIALLY INAPPROPRIATELY WITHHELD BY PR LOGIC FOR A VENTRICULAR TACHYCARDIA (VT) EPISODE DETECTED AS SUPRA VENTRICULAR TACHYCARDIA (SVT). IT WAS ALSO NOTED THAT ON ANOTHER INSTANCE THE CRT-D MAY HAVE DELAYED THERAPY FOR A VT EPISODE DUE TO THE ATRIAL FIBRILLATION (AF)/ATRIAL FLUTTER DISCRIMINATOR. 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 24279289 ↗
• InjuryJan 8, 2026Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) 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 24004100 ↗
• MalfunctionDec 16, 2025Signal Artifact/Noise; Electromagnetic Interference; Signal Artifact/Noise; Electromagnetic Interference

  IT WAS REPORTED THAT OVERSENSING WAS NOTED ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR'S (CRT-D) ATRIAL CHANNEL DURING AN ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODE DUE TO ELECTROMAGNETIC INTERFERENCE NOISE. THE RIGHT VENTRICULAR (RV) LEAD E XHIBITED A GRADUAL INCREASE IN CAPTURE THRESHOLDS AND PACING IMPEDANCE IN ADDITION TO MULTIPLE ALERTS FOR LOW PACING IMPEDANCE. THE RIGHT ATRIAL (RA) LEAD EXHIBITED AN INCREASE IN CAPTURE THRESHOLDS TO HIGH LEVELS. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED AN INCREASE IN CAPTURE THRESHOLDS. THE CRT-D AND LEADS 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 23816900 ↗
• InjuryDec 4, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED PREMATURE BATTERY DEPLETION. THE CRTD 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 23717091 ↗
• InjuryNov 21, 2025Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED ASYSTOLE FOR FIFTEEN TO TWENTY SECONDS. THE RIGHT VENTRICULAR (RV) LEAD WAS NOTED TO BE PROGRAMMED SUB-THRESHOLD. ADDITIONALLY, IT WAS NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED LOSS OF BI-VENTRICULAR SUPPORT DURING ATRIAL CAPTURE MANAGEMENT(ACM) OPERATION WHEN THE DEVICE AUTOMATICALLY MONITORS ATRIAL PACING THRESHOLDS AT PERIODIC INTERVALS. IT WAS ALSO NOTED THAT THE CRT-D DEVICE HAD NOT COMPLETED ACM AT THE TIME OF THE THE REMOTE TRANSMISSION SO WOULD HAVE TRIED AT 30 MIN INTERVALS. IN ADDITION, THE PHYSICIAN ALSO WAS QUESTIONING THE LEFT BUNDLE BRANCH LEAD. THE RV LEAD, CRT-D AND LEFT BUNDLE BRANCH LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole

  MAUDE report 23622366 ↗

Other Medtronic, Inc. products

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