Percepta CRT-P MRI SureScanRecalls & reported problems across all models

We found 2 models of Percepta CRT-P MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 518 adverse event reports in the FDA's MAUDE database, received between Dec 7, 2017 and Sep 9, 2026 — classified as 6 deaths, 323 injuries, 189 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (84 reports).

1 FDA recall record name at least one of these models by its device identifier.

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

Percepta CRT-P MRI 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. Jun 21, 2018Class IITerminated

   Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature (VSP).

   Z-2412-2018 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

Most reported Percepta CRT-P MRI SureScan problems

Percepta CRT-P MRI SureScan models

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

• Percepta™ CRT-P MRI SureScan™ W1TR01

  Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 recall4 deaths300 reports
• Percepta™ CRT-P MRI SureScan™ W1TR01

  Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 recall2 deaths218 reports

Recent Percepta CRT-P MRI SureScan adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Pacing Problem

  Patient problems: Bradycardia

  MAUDE report 50698197 ↗
• MalfunctionSep 2, 2026Device Sensing Problem

  Patient problems: Tachycardia

  MAUDE report 50562150 ↗
• MalfunctionSep 1, 2026High impedance; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50539600 ↗
• MalfunctionAug 27, 2026Pacing Problem

  It was reported that approximately six weeks post implant of a Cardiac Resynchronization Therapy Pacemaker (CRT-P) system, the CRT-P was potentially  pacing below the lower rate. It was also reported that the patient experienced a fluctuating heart rate, nervousness, and fatigue. The CRT-P remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fatigue

  MAUDE report 50471887 ↗
• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced an infection and fever. The Cardiac Resynchronization Therapy Pacemaker (CRT-P) and the Right Atrial (RA) lead were explanted.  The epicardial Left Ventricular (LV) lead the epicardial Right Ventricular (RV) lead were partially explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 50436231 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed a Staphylococcus aureus infection. The Cardiac Resynchronization Therapy Pacemaker (CRT-P) system was explanted with no replacement. No further patient complications have been reported as a result of this event.

  Patient problems: Bacterial Infection; Medical device site infection

  MAUDE report 50317946 ↗
• MalfunctionJun 22, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED NOISE. THE IPG 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 25574425 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND EXPERIENCED SEPSIS AND ENTEROCOCCUS FAECALIS. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED WITH NO REPLACEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Drug Resistant Bacterial Infection; Sepsis; Unspecified Infection

  MAUDE report 25498744 ↗
• MalfunctionJun 12, 2026False Alarm; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) TRIGGERED A FALSE LOW IMPEDANCE ALERT FOR THE RIGHT VENTRICULAR (RV) LEAD. IT WAS ALSO REPORTED THAT THE RV LEAD EXHIBITED ELEVATED CAPTURE THRESHOLDS, WHICH RESULTED IN HIGH-OUTPUT RV PACING AND CONTRIBUTING TO ACCELERATED AND LOWER THAN EXPECTED BATTERY DEPLETION. THE CRT-P AND RV 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 25490876 ↗
• MalfunctionJun 11, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED PREMATURE BATTERY DEPLETION. 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 25467027 ↗
• MalfunctionJun 9, 2026Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA. IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED INTERMITTENT UNDERSENSING. IT WAS FURTHER NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING/HIGH IMPEDANCE AND A LEAD FRACTURE. IT WAS ALSO NOTED THAT THE RV LEAD EXHIBITED LOW OUTPUT AND HIGH THRESHOLDS. IT WAS FURTHER NOTED THAT PACING PRIMARILY OCCURS ON THE RV LEFT BUNDLE BRANCH (LBB) LEAD. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P), RA LEAD, RV LEAD AND LBB LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 25447395 ↗
• MalfunctionMay 14, 2026Electromagnetic Interference

  IT WAS REPORTED BY THE PATIENT THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED ELECTROMAGNETIC INTERFERENCE. THE CRT-P 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 25170482 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET EROSION/INFECTION, DISCOMFORT, FEVER AND PAIN. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS REMOVED AND REPLACED. THE LEADS WERE CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erosion; Fever; Pain; Unspecified Infection

  MAUDE report 24999365 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EROSION. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND LATER REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 24995484 ↗
• MalfunctionApr 23, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A HEALTHCARE PROFESSIONAL (HCP) STATED THEY INTERROGATED A PATIENT, BUT THE REPORT WAS NOT RECEIVED FROM THE REMOTE MONITORING MOBILE APPLICATION. THEY HAD SEEN THE TRANSMISSION GOING BUT AFTER SOME TIME THE SCREEN SHOWED AS ¿START¿. TECHNICAL SUPPORT CONFIRMED THE TRANSMISSION WAS NOT RECEIVED IN THE REMOTE MONITORING NETWORK. THE HCP STATED THEY WERE GOING TO REINTERROGATE BECAUSE THE PATIENT STATED THEY RECEIVED A REPORT THAT THEIR ¿DEVICE FAILED.¿ IT WAS ADVISED TO RETRY THE INTERROGATION AND CHECK ON A DIFFERENT WIRELESS-FIDELITY (WI-FI). THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) 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 24974845 ↗

Other Medtronic, Inc. products

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