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

We found 8 models of Amplia MRI Quad CRT-D SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,423 adverse event reports in the FDA's MAUDE database, received between Dec 9, 2016 and Sep 9, 2026 — classified as 32 deaths, 916 injuries, 475 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (201 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

Amplia 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-1764-2023 · 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-1763-2023 · 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 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 Amplia MRI Quad CRT-D SureScan problems

Amplia MRI Quad CRT-D SureScan models

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

• Amplia MRI™ Quad CRT-D SureScan™ DTMB1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 recalls18 deaths648 reports
• Amplia MRI™ Quad CRT-D SureScan™ DTMB1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall5 deaths268 reports
• Amplia MRI™ Quad CRT-D SureScan™ DTMB1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall2 deaths177 reports
• Amplia MRI™ Quad CRT-D SureScan™ DTMB1Q1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls2 deaths68 reports
• Amplia MRI™ Quad CRT-D SureScan™ DTMB1QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall3 deaths107 reports
• Amplia MRI™ Quad CRT-D SureScan™ DTMB1Q1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall1 death78 reports
• Amplia MRI™ Quad CRT-D SureScan™ DTMB1Q1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  1 recall1 death61 reports
• Amplia MRI™ Quad CRT-D SureScan™ DTMB1Q1

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

Recent Amplia 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.

• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient presented to the emergency department with sceptic shock due to Methicillin-resistant Staphylococcus aureus bacteremia, requiring vasopressor administration. Transesophageal Echocardiography (TEE) confirmed vegetation on the Right Ventricular (RV) lead and Right Atrial (RA) lead. Computerized tomography (CT) scan could not discern if the patient was experiencing pneumonia or sceptic pulmonary emboli. 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; Drug Resistant Bacterial Infection; Medical device site infection; Pneumonia; Pulmonary Embolism; Sepsis; Septic Shock

  MAUDE report 50691810 ↗
• MalfunctionSep 3, 2026Electromagnetic Interference; Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50592016 ↗
• InjuryAug 24, 2026Defibrillation/Stimulation Problem; Device Sensing Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) inappropriately withheld therapy for events that were misclassified as Ventricular Fibrillation (VF) by the Atrial Flutter (AF) by the device discriminator. The device discriminator was turned off. The device remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50419005 ↗
• MalfunctionJul 7, 2026Over-Sensing

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO ELEVATED SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED EPISODES. THE PATIENT WAS SEEN IN CLINIC AND NO PRODUCT ISSUES WERE OBSERVED, THE PHYSICIAN NOTED THAT THE LIA WAS NOT OF CONCERN AS IT WAS TRIGGERED DUE TO THE PATIENT PLUGGING IN A DRYER THAT HAS A LIKELY SHORT. THE CRTD 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 25734802 ↗
• MalfunctionJul 2, 2026Device Sensing Problem; Data Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) POST PACE, RESULTING IN INHIBITION/DELAY OF PACING. THE RV LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) VERSUS A MONITORED VENTRICULAR TACHYCARDIA (VT) WITH 1 TO1 SUPRA VENTRICULAR TACHYCARDIA (SVT) ATRIAL EVENTS FALLING INTO THE BLANKING PERIOD. ADDITIONALLY, THE CRT-D DEVICE INTERROGATION REPORTED DISPLAYED AN OBSERVATION WHEN THE DEVICE FEATURE THAT AUTOMATICALLY MONITORS PACING THRESHOLDS AT PERIODIC INTERVALS IS PROGRAMMED OFF. 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 25696412 ↗
• InjuryJun 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PATIENT HAD EXPERIENCED A STROKE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Stroke/CVA

  MAUDE report 25673680 ↗
• InjuryMay 27, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY AND ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT). ADDITIONALLY, IT WAS NOTED THAT THE EPISODE DID NOT MEET DISCRIMINATOR CRITERIA; THEREFORE, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED THERAPY PER PROGRAMMING. 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 25306097 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL FOR A PROCEDURE, WHICH WAS CANCELLED DUE TO A BLOOD CLOT IN THEIR HEART. THE PATIENT WAS PUT ON AN ANTICOAGULANT MEDICATION, AND A DAY LATER, THEY "FELT AN ITCHING FEELING INSIDE THE PACEMAKER." 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: Embolism/Embolus; Itching Sensation

  MAUDE report 25237497 ↗
• MalfunctionMay 19, 2026Failure to Interrogate; Battery Problem

  THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218738 ↗
• MalfunctionMay 18, 2026Premature Discharge of Battery; Battery Problem

  IT WAS REPORTED BY THE PATIENTS REPRESENTATIVE THAT THE PATIENT WENT IN FOR AN MAGNETIC RESONANCE IMAGING (MRI) AND FOUND OUT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) BATTERY WAS DEAD. 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 25205832 ↗
• InjuryApr 21, 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. IT WAS NOTED THAT THE INFECTION ORGANISM WAS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. THE PATIENT EXPERIENCED SEPSIS, FEVER, AND VEGETATION ON THE LEADS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Drug Resistant Bacterial Infection; Fever; Medical device site infection; Sepsis

  MAUDE report 24941928 ↗
• InjuryApr 9, 2026Premature 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 24832383 ↗
• MalfunctionApr 8, 2026Electromagnetic Interference

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED NOISE/OVERSENSING SUGGESTIVE OF ELECTROMAGNETIC INTERFERENCE (EMI). NOISE EPISODES ARE OCCURRING AROUND THE SAME TIME EACH DAY. 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 24818617 ↗
• InjuryApr 8, 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. THERE WAS VEGETATION OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD, AND THE PATIENT HAD A POSITIVE CULTURE FOR KLEBSIELLA PNEUMONIAE. DURING EXPLANT, THE LEFT VENTRICULAR (LV) LEAD FRACTURED DISTALLY BEFORE THE ENTIRE LEAD COULD BE FULLY REMOVED. MOST OF THE LV LEAD WAS REMOVED EXCEPT FOR THE TIP, WHICH REMAINS IN THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24817263 ↗
• MalfunctionApr 2, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PATIENT WHILE RIDING ON A BUS ON A BUMPY ROAD THE CRTD EXHIBITED INTERMITTENT DETECTION FOR AN ARRYTHMIA. THE PATIENT WAS PUT ON MEDICATION. 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 24768234 ↗

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