Percepta™ Quad CRT-P MRI SureScan™ W4TR01 (UDI 00643169891418)Recalls & reported problems

Summary

The FDA's MAUDE database contains 897 adverse event reports that list this exact device (DI 00643169891418), received between Feb 8, 2018 and Sep 30, 2026 — classified as 28 deaths, 501 injuries, 368 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (116 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 897 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Inappropriate or Unexpected Reset; Reset Problem

  It was reported that the Implantable Pulse Generator (IPG) exhibited a partial and a full reset. The IPG 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 50946489 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Medical device site infection

  MAUDE report 50891976 ↗
• InjurySep 23, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the Cardiac Resynchronization Therapy Pacemaker (CRT-P) system was explanted for an unknown/unspecified reason. A new system was implanted a few days later. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872061 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 50826989 ↗
• InjurySep 17, 2026Appropriate Device Problem Term/Code Not Available

  It was reported by the patient that they inquired regarding contact with a local manufacturer representative for assistance regarding adjustment of their Cardiac Resynchronization Therapy Pacemaker (CRT-P). It was further reported by the patient that they had previously experienced fluttering in their chest after a pacemaker adjustment and were seeking further help. The patient stated that the feelings have reoccurred stating "a fluttering in my chest when lying on my back". The patient was referred to their physician, and the CRT-P remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Palpitations

  MAUDE report 50808726 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a pocket infection, erosion and wound dehiscence. The Cardiac Resynchronization Therapy Pacemaker (CRT-P) system 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; Wound Dehiscence

  MAUDE report 50776888 ↗
• InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced infection. The Cardiac Resynchronization Therapy Pacemaker (CRT-P) system 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: Unspecified Infection

  MAUDE report 50767754 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Atrial Fibrillation; Bradycardia

  MAUDE report 50764841 ↗
• InjurySep 11, 2026Migration or Expulsion of Device

  It was reported that the patient experienced shortness of breath and a fall and that the Right Atrial (RA) lead exhibited no capture and dislodgement. It was further reported that the Right Ventricular (RV) lead exhibited high thresholds and micro dislodgment. It was further noted that the Cardiac Resynchronization Therapy Pacemaker (CRT-P) had migrated from its original position in the pocket. The system was explanted and replaced. No patient complications have been reported as a result of this event.

  Patient problems: Dyspnea; Fall

  MAUDE report 50728091 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Medical device site infection

  MAUDE report 50679357 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Endocarditis; Medical device site infection

  MAUDE report 50597826 ↗
• MalfunctionSep 2, 2026Device Sensing Problem

  Patient problems: Chest Pain; Dyspnea

  MAUDE report 50571434 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 50541963 ↗
• MalfunctionSep 1, 2026Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50539284 ↗
• MalfunctionAug 31, 2026False Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50518616 ↗
• MalfunctionAug 28, 2026Extracardiac stimulation

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50503679 ↗
• MalfunctionAug 28, 2026Pacing Problem

  Patient problems: Bradycardia; Insufficient Information

  MAUDE report 50499765 ↗
• MalfunctionAug 28, 2026False Alarm

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50492984 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Pacemaker (CRT-P) system was explanted due to a pocket infection and redness. No further patient complications have been reported as a result of this event.

  Patient problems: Erythema; Unspecified Infection

  MAUDE report 50451864 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Pacemaker (CRT-P) patient experienced an bacteremia infection. The device system was explanted . No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 50417070 ↗
• InjuryAug 24, 2026Pacing Problem

  It was reported that the patient experienced syncope, a fall and was in a car accident. It was further reported that the Cardiac Resynchronization Therapy Pacemaker (CRT-P) exhibited a pacing issue, the Right Ventricular (RV) lead exhibited high thresholds and intermittent capture  and that the Left Ventricular (LV) lead exhibited no capture.  The CRTP system remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Fall; Syncope/Fainting

  MAUDE report 50409091 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 50355708 ↗
• InjuryAug 14, 2026Appropriate Device Problem Term/Code Not Available

  It was reported by the patient that two days after implant, the Cardiac Resynchronization Therapy Pacemaker (CRT-P) was beeping when they were lying down. The patient described it as ¿feeling the beeping¿ when lying down and it happened at the hospital after implant and was adjusted. Now it is happening again. The CRT-P remains in use. No further patient complications have been reported as a result of this event.

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

  MAUDE report 50256537 ↗
• MalfunctionAug 13, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the Cardiac Resynchronization Therapy Pacemaker (CRT-P) "might not be working." 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 50235594 ↗
• InjuryAug 8, 2026Premature Discharge of Battery

  It was reported that the Right Ventricular (RV) lead exhibited variable thresholds causing an unexpected drop in battery longevity. The RV lead and Cardiac Resynchronization Therapy Pacemaker (CRT-P) remain in use. No patient complications have been reported as aresult of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50186664 ↗

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-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-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.