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

We found 2 models of Percepta Quad CRT-P MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,600 adverse event reports in the FDA's MAUDE database, received between Aug 9, 2017 and Sep 30, 2026 — classified as 36 deaths, 900 injuries, 664 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (156 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 Quad 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-2413-2018 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

Most reported Percepta Quad CRT-P MRI SureScan problems

Percepta Quad CRT-P MRI SureScan models

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

• Percepta™ Quad CRT-P MRI SureScan™ W4TR01

  Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 recall28 deaths897 reports
• Percepta™ Quad CRT-P MRI SureScan™ W4TR01

  Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  1 recall8 deaths703 reports

Recent Percepta Quad 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.

• 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 ↗
• 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 ↗
• 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 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
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• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
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