Percepta™ Quad CRT-P MRI SureScan™ W4TR01 (UDI 00643169735644)Recalls & reported problems

Summary

The FDA's MAUDE database contains 703 adverse event reports that list this exact device (DI 00643169735644), received between Aug 9, 2017 and Sep 30, 2026 — classified as 8 deaths, 399 injuries, 296 malfunctions.

The most frequently reported specific device problem is “Inappropriate or Unexpected Reset” (110 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-2413-2018 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 703 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Failure to Interrogate

  It was reported that the Cardiac Resynchronization Therapy Pacemaker (CRT-P) was unable to interrogated by the remote monitoring mobile application. The CRTP 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 50946107 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Pacemaker (CRT-P) system was explanted and replaced with an Implantable Pulse Generator (IPG) system due to bacteremia. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia

  MAUDE report 50379329 ↗
• MalfunctionMar 20, 2026Missing Test Results

  IT WAS REPORTED THAT DEVICE WAS UNABLE TO MEASURE BV FOR MORE THAN A WEEK. THE BV MEASUREMENTS HAVE RESUMED AND IMPLANTABLE PULSE GENERATOR (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 24649578 ↗
• MalfunctionFeb 10, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED TELEMETRY ISSUES DUE TO DEVICE DEPLETION. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS. THE DEVICE AND 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 24305288 ↗
• InjuryFeb 6, 2026Incorrect Measurement

  THE DEVICE 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 24276029 ↗
• InjuryJan 29, 2026Pacing Problem

  IT WAS IDENTIFIED UPON FURTHER REVIEW THAT THIS IS A SOFTER APPLICATION ANOMALY WHERE THE PROGRAMMER USER INTERFACE FAILS TO POPULATE THE PROGRAMMER VECTOR LIST PROCESSING MULTIPLE EOS/RRT VALUES. THE IMPLANTABLE DEVICE CONTINUES TO FUNCTION AND REPORT AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208051 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED AN INFECTION WITH ADDITIONAL PATIENT SYMPTOMS OF BACTEREMIA. THE BI-VENTRICULAR PACEMAKER SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 23848668 ↗
• InjuryNov 6, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT, AFTER REVIEW OF EXTERNAL CARDIAC TELEMETRY, IT WAS SUSPECTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE. IT WAS ALSO REPORTED THAT THE PATIENT'S HEART RATE WAS BELOW THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) PROGRAMMED LOWER RATE. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 23493100 ↗
• MalfunctionOct 28, 2025False Alarm; False Alarm

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED A FALSE LOW IMPEDANCE WARNING. IT WAS NOTED THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A POLARITY SWITCH. THE IPG AND RV LEAD 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 23406499 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND REPLACED DUE TO EROSION. THE PATIENT REPORTED THAT "THERE'S A HOLE ABOVE THE PACEMAKER; IT IS EXPOSED THROUGH THE SKIN" AND THAT IT WAS "SIZE OF A DIME" AND THEY COULD "TOUCH IT AND SEE IT". NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 23373227 ↗
• InjuryOct 15, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE BI-VENTRICULAR PACEMAKER WAS EXPLANTED AND REPLACED DUE TO UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23276484 ↗
• InjurySep 15, 2025Failure to Interrogate; Pacing Problem; Failure to Interrogate; Pacing Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRIGGERED ALERTS FOR HIGH THRESHOLDS. APPROXIMATELY FOUR YEARS LATER, THE PATIENT WAS AT A DENTAL VISIT AND THEIR HEART RATE WAS IN THE 30 BEATS PER MINUTE RANGE. THE PATIENT EXPERIENCED DISORIENTATION AND CONFUSION. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS UNABLE TO BE INTERROGATED AND WAS SUSPECTED TO NOT BE PACING. IT WAS NOTED THAT THE DEVICE BATTERY WAS COMPLETELY DEPLETED. THE CRT-P WAS EXPLANTED AND REPLACED. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Confusion/ Disorientation

  MAUDE report 23058804 ↗
• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BACTEREMIA INFECTION. THERE WAS VEGETATION NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE ORGANISM RESPONSIBLE FOR THE INFECTION WAS IDENTIFIED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. 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: Bacteremia; Drug Resistant Bacterial Infection; Unspecified Infection

  MAUDE report 22917798 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO ENDOCARDITIS. THE INFECTION SOURCE WAS NOTED TO BE THE MITRAL VALVE IMPLANT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 22900281 ↗
• MalfunctionAug 14, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED BY THE PATIENT AND PATIENT REPRESENTATIVE, THAT THE PATIENT WAS OBSERVING THEIR HEART RATES IN THE FORTIES, VIA THEIR HOME HEART RATE MONITOR. THE PATIENT REPRESENTATIVE ALSO STATED, "IT GOES INTO THIS SERIES OF UPS AND DOWNS". THE PATIENT WAS UNSURE IF THIS WAS RELATED TO THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P), THEIR HOME MONITOR, OR THE PATIENT'S DIET. THE CRTP REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Irregular Pulse

  MAUDE report 22805995 ↗
• DeathAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED BACTERIAL INFECTION ALONG WITH PROTRUSION NOTED AT THE IMPLANT SITE RESULTING IN REDNESS, SWELLING, PAIN, DISCOMFORT AND PUS DISCHARGE. THE ORGANISM WAS IDENTIFIED TO BE KLEBSIELLA. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED. ONE WEEK LATER, THE PATIENT PASSED AWAY.

  Patient problems: Bacterial Infection; Discomfort; Erosion; Erythema; Pain; Purulent Discharge; Swelling/ Edema

  MAUDE report 22803129 ↗
• MalfunctionJul 24, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT DURING CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) PROGRAMMING, THE PROGRAMMER SCREEN DISPLAYED A RED X WITH A MESSAGE THAT STATED "DEVICE NOT READY". REINTERROGATING THE DEVICE WAS ATTEMPTED, BUT THE MESSAGE WITH THE RED X STILL DISPLAYED. 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 22592744 ↗
• MalfunctionJul 4, 2025Premature Discharge of Battery; Data Problem; Premature Discharge of Battery; Data Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED PREMATURE BATTERY DEPLETION. 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 22402873 ↗
• InjuryJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS AND BACTEREMIA INFECTIONS AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 22395065 ↗
• DeathJun 26, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY A REPRESENTATIVE OF THE PATIENT THAT THE PATIENT PASSED AWAY BECAUSE OF THEIR CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). ADDITIONAL INFORMATION RELATED TO THE CAUSE OF DEATH WAS REQUESTED AND IS NOT AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22340704 ↗
• InjuryMay 7, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEIR HEART STOPPED AND THEY WERE RESUSCITATED. THE PATIENT STATED THAT THE PHYSICIAN STATED THAT THERE WAS SOMETHING THAT HAD SHOWED UP ON THEIR TRANSMISSION THE PRIOR MONTH TO THE PATIENT EXPERIENCING THE CARDIAC ARREST. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bone Fracture(s); Cardiac Arrest; Coma; Dizziness; Memory Loss/Impairment

  MAUDE report 21978890 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER THE FOLLOWING DAY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21970024 ↗
• InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPLANTED DUE TO A BACTEREMIA INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 21967889 ↗
• MalfunctionMar 20, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WOULD RUN TESTS AND IT WAS APPARENT, HOWEVER A WEEK OR TWO PRIOR TO THE CALL, THE PATIENT DID NOT FEEL THE TESTING AND BELIEVE SOMETHING MAY HAVE BEEN WRONG WITH THEIR DEVICE. 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 21656832 ↗
• MalfunctionFeb 26, 2025False Alarm; False Alarm

  IT WAS REPORTED THAT THERE WAS A LEFT VENTRICULAR (LV) LEAD LOW IMPEDANCE WARNING ON THE DEVICE, HOWEVER, WHEN INTERROGATED THE LEAD TRENDS SHOWED NO OUT-OF-RANGE IMPEDANCES. 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 21471191 ↗

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-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-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-2513-2020 · Jun 4, 2020 · Open, Classified
  Solara CRT-P MRI, Model Numbers: a) W1TR03, b) W1TR06, c) W4TR03, d) W4TR06
• Z-2512-2020 · Jun 4, 2020 · Open, Classified
  Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05
• Z-2511-2020 · Jun 4, 2020 · Open, Classified
  Percepta CRT-P MRI, Model Numbers: a) W1TR01, b) W1TR04, c) W4TR01, d) W4TR04
• 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-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-2412-2018 · Jun 21, 2018 · Terminated
  Percepta CRT-P MRI SureScan, REF W1TR01 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.