Solara™ CRT-P MRI SureScan™ W1TR03 (UDI 00643169735675)Recalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 00643169735675), received between Feb 8, 2018 and Jan 15, 2026 — classified as 3 deaths, 44 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (18 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 76 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Pacing Problem

  IT WAS REPORTED BY THE PATIENT'S WIFE THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) IS INCORRECTLY PACING ON THE RIGHT SIDE. 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 24078324 ↗
• MalfunctionNov 14, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS RETURNED TO THE MANUFACTURER, ANALYZED AND TESTED OUT OF SPECIFICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23552527 ↗
• InjuryOct 16, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DEVICE IS AT ELECTIVE REPLACEMENT INDICATOR (ERI).  MODE SET TO VVI/65 BPM, ALL ATRIAL TACHYCARDIA/ATRIAL F IBRILLATION (AT/AF) THERAPIES SET TO OFF. THE PATIENT  IS REPORTING PALPITATIONS, CLINICIAN REPORTING SHE SEES RHYTHM CHANGES ON THE TELE WHEN PATIENT IS HAVING PALPITATIONS. THE DEVICE WAS REPROGRAMMED. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Discomfort

  MAUDE report 23309027 ↗
• InjuryApr 21, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21876205 ↗
• InjuryJun 4, 2024Communication or Transmission Problem; Reset Problem; Communication or Transmission Problem; Reset Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS UNABLE TO BE INTERROGATED BY THE MOBILE PROGRAMMER DESPITE REPEATED ATTEMPTS. INTERROGATION WAS THEN ATTEMPTED USING A LEGACY PROGRAMMER WHICH DISPLAYED A MESSAGE STATING "FLASH MEMORY FAILURE, ERROR - DEVICE (PACEMAKER) RESET. SERIOUS DEVICE MEMORY FAILURE. DEVICE SHOULD BE EXPLANTED." IT WAS ALSO NOTED THAT THE CRT-P HAD MANY RESETS WHICH WERE REFERRED TO AS A "RESET STORM". THE CRT-P WAS EXPLANTED AND REPLACED. THE MOBILE PROGRAMMER AND LEGACY PROGRAMMER 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 19460911 ↗
• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD A SKIN RASH THAT HAD BECOME QUITE SEVERE. THE PATIENT HAD SEEN A DERMATOLOGIST FOR YEARS FOR THE SKIN RASH THAT DEVELOPED SHORTLY AFTER ORIGINAL IMPLANT. THE RASH WAS INITIALLY THOUGHT TO BE ECZEMA. THE PATIENT ALSO STATED THAT AFTER THE MOST RECENT DEVICE CHANGE OUT, THE RASH HAS GOTTEN PROGRESSIVELY WORSE. THE DERMATOLOGIST PERFORMED A BIOPSY AND DETERMINED THE SKIN RASH WAS DUE TO THE PATIENT BEING ALLERGIC TO YEAST AND NOT ANYTHING "IN THEIR DEVICE". THE YEAST INFECTION WILL BE TREATED BY THE PHYSICIAN. THE SOURCE OF THE YEAST INFECTION WAS NOT KNOWN. THE CRT-P SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fungal Infection; Rash

  MAUDE report 19394921 ↗
• InjuryDec 11, 2023Adverse 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 SYSTEMIC INFECTION THAT WAS IDENTIFIED AS STAPHYLOCOCCUS AUREUS. THE CRT-P WAS REPLACED WITH A TEMPORARY PACING LEAD AND PACEMAKER. THE TEMPORARY SYSTEM WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A NEW CRT-P SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Unspecified Infection

  MAUDE report 18303222 ↗
• InjuryDec 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO INFECTION.  SUBSEQUENTLY, A FEW DAYS LATER A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 18257169 ↗
• MalfunctionNov 20, 2023Battery Problem; Battery Problem

  THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) 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 18169807 ↗
• MalfunctionAug 17, 2023Data Problem; Data Problem

  IT WAS REPORTED BY THE PATIENT'S SPOUSE THAT THE PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) HAS ONLY LASTED 5 YEARS AND BELIEVED THAT IT WAS GOING TO LAST LONGER. 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 17568871 ↗
• InjuryJul 27, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THEY HAD PREVIOUSLY EXPERIENCED ISSUES WITH BATTERY DEPLETION ON THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). THE DEVICE WAS REPROGRAMMED WHICH SEEMED TO HELP FOR A WHILE. THE PATIENT STATED THAT THE BATTERY IS LOW AGAIN. 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 17409735 ↗
• InjuryJun 12, 2023Low impedance; Low impedance

  IT WAS REPORTED THAT DURING USE OF THE RIGHT VENTRICULAR (RV) LEAD AN IMPEDANCE WARNING TRIGGERED WITH A POLARITY SWITCH.  THE RV LEAD THRESHOLD GRADUALLY INCREASED AND WAS HIGH.  THE RIGHT ATRIAL (RA) LEAD AND RV LEAD EXHIBITED A GRADUAL DECREASE IN IMPEDANCE THAT IS INDICATIVE OF INSULATION DEGRADATION.  IT WAS NOTED THAT THE RA LEAD HAD BEEN PROGRAMMED OFF DUE TO CHRONIC ATRIAL FIBRILLATION (AF).    IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED POSSIBLE HIGH THRESHOLD AND THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) A FALSE LOW IMPEDANCE WARNING TRIGGERED.  THE CRT-P AND LEADS APPEARED TO BE FUNCTIONING AS PROGRAMMED DESPITE LEAD WARNINGS.  SUBSEQUENTLY, THE CRT-P WAS EXPLANTED AND REPLACED.  THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED, AND A NEW RV LEAD WAS IMPLANTED.  THE RA LEAD AND LV 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 17108754 ↗
• InjuryMay 18, 2023Premature 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 16957464 ↗
• InjuryApr 17, 2023Adverse 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 16754051 ↗
• MalfunctionApr 14, 2023Low impedance; Low impedance

  IT WAS REPORTED THAT THERE WAS A RIGHT ATRIAL (RA) LEAD LOW IMPEDANCE WARNING ON THE DEVICE, HOWEVER, THE INTERROGATION SHOWED NO OUT OF RANGE IMPEDANCES ON THE LEAD TRENDS. 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 16744250 ↗
• MalfunctionMar 15, 2023Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P), ATRIAL AND VENTRICULAR OVERSENSING OCCURRED DUE TO EXTERNAL ELECTROCAUTERY BEING PERFORMED. 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 16546893 ↗
• InjuryMar 8, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION ON THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). ADDITIONAL IN FORMATION RECEIVED BY THE PATIENT REPORTING THAT THE DEVICE HAD BEEN LOSING BATTERY LIFE RAPIDLY OVER THE LAST FEW MONTHS. PATIENT NOTED THAT OVER TWO WEEKS AGO THEY HAD THIRTY DAYS BEFORE THE DEVICE NEEDED TO BE REPLACED BUT PRIOR TO THAT THEY WERE TOLD THEY HAD MONTHS OF BATTERY REMAINING. THE PATIENT IS CONCERNED THAT THEY WILL DROP DEAD WHEN THE DEVICE BATTERY REACHES THE END. 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 16506338 ↗
• InjuryJan 19, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION, THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS, AND THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED PREMATURE BATTERY DEPLETION. THE LV LEAD WAS REPROGRAMMED AND THE CRT-P 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 16210080 ↗
• InjuryJan 18, 2023Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED UNEXPECTED ACCELERATED BATTERY DEPLETION. THE ESTIMATED REMAINING LONGEVITY DECREASED BY HALF IN APPROXIMATELY SIX MONTHS. THE CRT-D WAS REPROGRAMMED AND 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 16199216 ↗
• InjurySep 16, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15441809 ↗
• InjuryAug 10, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS PREMATURE BATTERY DEPLETION ON THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). IT WAS ALSO N OTED THE LEFT VENTRICULAR (LV) LEAD THRESHOLD HAD BEEN HIGH SINCE IMPLANT. THE DEVICE WAS EXPLANTED AND REPLACED AND THE 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 15202208 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS INFECTED WITH VEGETATION ON THE LEADS. THE CRT-P SYSTEM WAS EXTRACTED. ANTIBIOTIC TREATMENT WAS ADMINISTERED. A TEMPORARY PACEMAKER AND LEAD, PLACED VIA THE INTRAJUGULAR VEIN, WAS PLACED UNTIL A NEW CRT-P SYSTEM WAS IMPLANTED ON THE RIGHT SIDE SEVEN DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 14990097 ↗
• MalfunctionJun 10, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THERE WAS A CONCERN REGARDING THE LONGEVITY ESTIMATION ON THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). IT WAS NOTED THERE WAS INTERMITTENT UNDERSENSING DURING ATRIAL FIBRILLATION (AF) AND HIGH OUTPUT ON THE RIGHT ATRIAL (RA) LEAD AND THE LEFT VENTRICULAR (LV) LEAD OUTPUT HAD INCREASED. THE DEVICE AND LEADS 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 14653861 ↗
• InjuryJun 8, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS INSULATION HAD ERODED AND THE LEADS HAD ADHERED TO EACH OTHER. IT WAS FURTHER REPORTED THAT THE RA AND RV LEADS EXHIBITED NOISE OVERSENSING, AND THE RA LEAD EXHIBITED UNDERSENSING AND HIGH THRESHOLDS. IT WAS ALSO REPORTED THAT THE HIS LEAD EXHIBITED HIGH THRESHOLDS. ALL THE LEADS WERE CAPPED AND REPLACED. IT WAS FURTHER REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED PREMATURE BATTERY DEPLETION. THE CRT-P 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 14633207 ↗
• InjuryJun 7, 2022Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED PREMATURE BATTERY DEPLETION. THE CRT-P 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 14618974 ↗

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-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-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-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-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.