Percepta™ CRT-P MRI SureScan™ W1TR01 (UDI 00643169891401)Recalls & reported problems

Summary

The FDA's MAUDE database contains 300 adverse event reports that list this exact device (DI 00643169891401), received between Jul 29, 2020 and Sep 9, 2026 — classified as 4 deaths, 187 injuries, 109 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (36 reports).

1 FDA recall record name this device's identifier.

9 other recalls cover devices cleared under the same FDA submission (P010015); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 300 reports, 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 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED POCKET EROSION. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS REVISED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 24957449 ↗
• MalfunctionApr 15, 2026Electromagnetic Interference

  IT WAS REPORTED APPROXIMATELY TWO MONTHS POST IMPLANT THAT THE PATIENT EXPERIENCED CHEST PAIN. IT WAS ALSO REPORTED THAT THE THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED ELECTROMAGNETIC INTERFERENCE/NOISE. THE IPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 24881453 ↗
• InjuryApr 9, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT ONE DAY POST IMPLANT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE (OOR) HIGH IMPEDANCE, VARYING IMPEDANCE, INTERMITTENT CAPTURE, NO CAPTURE, HIGH THRESHOLDS AND LEAD PERFORATION. THE PATIENT EXPERIENCED CHEST PAIN AND PLEURAL EFFUSION RELATED TO THE RV LEAD AND CRT-P. REPROGRAMMING WAS PERFORMED. TWO DAYS LATER IT WAS REPORTED THAT THERE WAS ANOTHER RV LEAD PERFORATION AND THAT THE LEFT VENTRICULAR (LV) LEFT BUNDLE BRANCH LEAD DISLODGED - EXTRAVASCULAR LEAD ANCHOR SLEEVE SLIPPAGE. THE RV AND LV LEADS WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Pleural Effusion

  MAUDE report 24828317 ↗
• InjuryApr 8, 2026Premature Discharge of Battery

  IT WAS FURTHER REPORTED THAT NO PERFORMANCE ISSUES WERE NOTED AGAINST THE LV LEAD. THE LV LEAD REMAINS IN USE. THE RV SHOWED OVERSENSING. THE RV LEAD WAS CAPPED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24813487 ↗
• MalfunctionApr 3, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A LEFT VENTRICULAR (LV) LEAD TIP TO CAN ISSUE. 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 24777458 ↗
• DeathApr 2, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT'S REPRESENTATIVE THAT THE PATIENT IS DECEASED. THE PATIENT EXPERIENCED AN INFECTION. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REPLACED WITH A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). THREE DAYS FOLLOWING THE REPLACEMENT THE PATIENT DIED.

  Patient problems: Insufficient Information

  MAUDE report 24764710 ↗
• InjuryApr 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, A POCKET INFECTION AND EROSION. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPLANTED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Medical device site infection; Pain; Unspecified Infection

  MAUDE report 24752061 ↗
• InjuryMar 19, 2026Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P,) DETECTED VENTRICULAR TACHYCARDIA (VT) THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT) OR DUAL TACHYCARDIA. REVIEW OF THE ELECTROGRAMS (EGM) CONFIRM ATRIAL RATES BELOW THE LOWER RATE LIMIT (LRL). IN ADDITION, THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS RESULTING IN UNNECESSARY/INAPPROPRIATE ATRIAL PACING AT TIMES. IN ADDITION, LOW P-WAVES WERE NOTED. THE CRT-P AND RA LEAD REMAIN IN USE. THE PATIENT ALSO EXPERIENCED SYNCOPE WITH A HEART RATE OF 38BPM.

  Patient problems: Bradycardia; Syncope/Fainting; Tachycardia

  MAUDE report 24640480 ↗
• InjuryMar 18, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED PREMATURE BATTERY DEPLETION. THE CRTP 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 24625325 ↗
• InjuryMar 11, 2026Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THEIR LEFT BUNDLE BRANCH (LBB) LEAD EXHIBITED HIGH THRESHOLDS WHICH CONTRIBUTED TO PREMATURE BATTERY DEPLETION OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). THE LBB LEAD AND CRT-P WERE REPROGRAMMED AND 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 24575254 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P010015. One submission often covers many models, so check the product and lot details in each record.

• Z-2128-2025 · Jun 17, 2025 · Open, Classified
  Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model N
• Z-2127-2025 · Jun 17, 2025 · Open, Classified
  Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D
• Z-2511-2020 · Jun 4, 2020 · Open, Classified
  Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
• Z-2512-2020 · Jun 4, 2020 · Open, Classified
  Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05
• Z-2513-2020 · Jun 4, 2020 · Open, Classified
  Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
• Z-2413-2018 · Jun 21, 2018 · Terminated
  Percepta Quad CRT-P MRI SureScan, REF W4TR01 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor
• Z-2415-2018 · Jun 21, 2018 · Terminated
  Percepta Quad CRT-P MRI SureScan, REF W4TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor
• Z-2414-2018 · Jun 21, 2018 · Terminated
  Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and
• Z-0342-2016 · Nov 9, 2015 · Terminated
  Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.