Solara™ Quad CRT-P MRI SureScan™ W4TR03 (UDI 00643169735682)Recalls & reported problems

Summary

The FDA's MAUDE database contains 140 adverse event reports that list this exact device (DI 00643169735682), received between Oct 6, 2017 and Aug 18, 2026 — classified as 2 deaths, 98 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (15 reports).

10 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 140 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced a pocket infection that presented with discomfort, redness, and purulent discharge/pus. The Cardiac Resynchronization Therapy Pacemaker (CRT-P) system was explanted and a leadless pacemaker was implanted. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Erythema; Medical device site infection; Purulent Discharge

  MAUDE report 50308366 ↗
• MalfunctionAug 11, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the patient's representative wanted to confirm that the Cardiac Resynchronization Therapy Pacemaker (CRT-P) was working. The patient's physician reportedly indicated the device was working but the patient was having some extra/double beats. The representative wanted to know if it was normal to have double beats or if that meant the device was failing to work. 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 50206494 ↗
• InjuryApr 6, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED BECAUSE ¿IT GOT BAD¿ AND WAS REPLACED WITH A COMPETITOR SYSTEM. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793203 ↗
• InjuryOct 22, 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 INFECTION. THE SYSTEM WAS REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 23359190 ↗
• InjuryAug 5, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY A PATIENT THAT THEIR DEVICE WAS REPLACED BECAUSE IT "WAS NOT WORKING ENOUGH OF WHAT IT WAS SUPPOSED TO DO". THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22715108 ↗
• InjuryJul 9, 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 A METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS INFECTION. THE PATIENT EXPERIENCED FEVER AND BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Drug Resistant Bacterial Infection; Fever

  MAUDE report 22461476 ↗
• MalfunctionApr 1, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY JUST UPGRADED THEIR WI-FI MODEM AND ROUTER AND INQUIRED FOR THE DISTANCE RECOMMENDATIONS. THE PATIENT STATED THAT ¿MY PACEMAKER IS ACTING GOOFY OR SOMETHING.¿ 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 21748682 ↗
• InjuryMar 28, 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 AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21718964 ↗
• InjuryMar 13, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THAT PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FOR HEART RATE MEASUREMENTS IN THE THIRTIES TO FORTIES WHILE MEASURING ON A PULSE OXIMETER. IT WAS FURTHER REPORTED BY THE PATIENT THAT THEIR HEART RATE GOES LOW THEY GET LIGHT HEADED. THE PATIENT STATED FURTHER THAT WHILE WATCHING TELEVISION ONE NIGHT, THEIR SMART WATCH ALERTED AND THEY OBSERVED HEART RATE READINGS OF THIRTY-FIVE, THIRTY-SEVEN, THIRTY-EIGHT, AND FORTY BEATS PER MINUTE OVER AN HOUR AND A HALF. THE PATIENT'S SPOUSE, WHO IS A NURSE, THEN TOOK THE PATIENT'S HEART RATE MANUALLY AND WAS MEASURING IN THE THIRTIES. THE PATIENT STATED THAT THEY THEN ENDED UP IN THE EMERGENCY DEPARTMENT AGAIN AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT NOTED THAT THE CLINICIANS CHECKED THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AND NOTED THAT "EVERYTHING WAS OKAY". THE PATIENT STATED THAT THEY ARE WORRIED SOMETHING IS WRONG WITH THEIR DEVICE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 21597236 ↗
• MalfunctionMar 7, 2025Data Problem; Data Problem

  IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) BATTERY STATUS HAD SHOWN TWO REMAINING YEARS FOR A WHILE AND THEY WERE CONCERNED THAT "SOMETHING MIGHT BE WRONG". 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 21549257 ↗
• MalfunctionFeb 26, 2025Battery Problem; Data Problem; Battery Problem; Data Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT HAD A DEVICE CHECK OR IN OFFICE VISIT. THE CRT-P WAS INDICATED AS NORMAL BATTERY DEPLETION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21470123 ↗
• InjuryFeb 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SYSTEMIC INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND REPLACED WITH A TRANSCATHETER PACING SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21436601 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEPSIS THAT ORIGINATED IN THE BLOODSTREAM. THE ORGANISM RESPONSIBLE FOR THE INFECTION WAS IDENTIFIED AS ENTEROCOCCUS. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Sepsis

  MAUDE report 20789824 ↗
• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS GIVEN ANTIBIOTICS AFTER THE EXPLANT AND IT WAS NOTED THAT CULTURES WERE PERFORMED AND THERE WAS NO GROWTH ON ANY OF THE LEADS.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 20765556 ↗
• InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS LATER REPORTED THAT THE PATIENT'S DIAGNOSIS WAS STAPHYLOCOCCUS AUREUS BACTEREMIA WITH SEPSIS.

  Patient problems: Bacteremia; Bacterial Infection; Sepsis; Unspecified Infection

  MAUDE report 20383766 ↗
• MalfunctionSep 12, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXPLANTED AND REPLACED DUE TO BEING AT NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20201456 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A STAPHYLOCOCCUS 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: Bacterial Infection

  MAUDE report 20050288 ↗
• MalfunctionMay 22, 2024False Alarm; False Alarm

  IT WAS REPORTED THAT THERE WAS A RIGHT ATRIAL (RA) 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 19375908 ↗
• InjuryMay 17, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS HIGH THRESHOLD, LOSS OF CAPTURE, AND PHRENIC NERVE STIMULATION ON THE LEFT VENTRICULAR (LV) LEAD. THERE WAS PREMATURE BATTERY DEPLETION ON THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P), NO INTERVENTION WAS PERFORMED ON THE LEAD AND IT REMAINS IN USE. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339926 ↗
• InjuryMar 25, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE 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 18970460 ↗
• InjuryFeb 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AROUND THEIR CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WHEN THE LEFT VENTRICULAR (LV) LEAD WAS PACING. THE LV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT CONTINUED TO FEEL PAIN WITH THE NEW LEAD WAS CONNECTED TO THE CRT-P, SO THE CRT-P WAS ALSO EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 18810834 ↗
• DeathFeb 21, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT TEN MINUTES INTO THE MRI, THE PATIENT WAS FOUND TO BE IN PULSELESS ELECTRICAL ACTIVITY. RETURN OF SPONTANEOUS CIRCULATION WAS ACHIEVED AND THEN THE PATIENT SUFFERED A SECOND ARREST AND SUBSEQUENTLY PASSED AWAY. THE PHYSICIAN FEELS THAT THIS WAS UNFORTUNATE TIMING, UNRELATED TO THE DEVICE AND NO ABNORMALITIES WERE FOUND UPON INTERROGATION OF THE DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 18754601 ↗
• MalfunctionFeb 14, 2024Low impedance; Low impedance

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) POSSIBLY TRIGGERED A FALSE LOW IMPEDANCE ALERT FOR THE RIGHT ATRIAL (RA) LEAD. 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 18708316 ↗
• InjuryFeb 2, 2024Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) HAD PREMATURE BATTERY DEPLETION. THE DEVICE 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 18636819 ↗
• MalfunctionJan 31, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  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 18613430 ↗

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-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-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-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-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-0342-2016 · Nov 9, 2015 · Terminated
  Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generator pacemaker.