Solara™ Quad CRT-P MRI SureScan™ W4TR03 (UDI 00643169891456)Recalls & reported problems

Summary

The FDA's MAUDE database contains 102 adverse event reports that list this exact device (DI 00643169891456), received between Apr 10, 2018 and Aug 30, 2026 — classified as 5 deaths, 60 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (11 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 102 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 50513024 ↗
• MalfunctionAug 26, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50453576 ↗
• InjuryJul 29, 2026Battery Problem

  It was reported that the Cardiac Resynchronization Therapy Pacemaker (CRT-P) had triggered Elective Replacement Indicator (ERI). The healthcare professional suspected a malfunction. 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 50074810 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Endocarditis

  MAUDE report 50073964 ↗
• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHORTNESS OF BREATH AND WAS ADMITTED TO HOSPITAL. CARDIAC EVALUATION INCLUDING A TRANSTHORACIC ECHOCARDIOGRAM REVEALED A NEW DECREASE IN LEFT VENTRICULAR EJECTION FRACTION WHICH WAS SUSPECTED TO BE PACER-INDUCED CARDIOMYOPATHY, GIVEN ONE HUNDRED PER CENT RIGHT VENTRICULAR (RV) PACING AND ABSENCE OF SIGNIFICANT CORONARY DISEASE. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AND THE RIGHT VENTRICULAR LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS A PARTICIPANT IN THE POST APPROVAL CLINICAL SURVEILLANCE PRODUCT SURVEILLANCE REGISTRY.

  Patient problems: Cardiomyopathy; Dyspnea

  MAUDE report 25545436 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND REPLACED APPROXIMATELY FOUR MONTHS LATER DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25001276 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FIVE WEEKS POST CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM IMPLANT, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A GAPING HOLE IN THEIR WOUND AND THE LEADS WERE VISIBLE. THE PATIENT EXPERIENCED EROSION, REDNESS, WOUND DEHISCENCE, AND INFECTION. IT WAS FURTHER REPORTED THAT THE PATIENT LIKES TO SCRATCH THEIR SKIN, AND THE PHYSICIAN BELIEVED THE PATIENT INFECTED IT THEMSELF. THE CRT-P SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Erythema; Unspecified Infection; Wound Dehiscence

  MAUDE report 24818893 ↗
• InjuryMar 20, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) BATTERY WAS NOTED TO BE DEPLETED FASTER THAN EXPECTED. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE RV LEAD AND LV LEAD OUTPUT WERE REPROGRAMMED. 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 24648953 ↗
• MalfunctionMar 19, 2026Pacing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEIR HEART RATE IS BETWEEN FORTH AND FIFTY BEATS-PER-MINUTE (BPM) AND IT SHOULD BE AT SEVENTY BPM. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 24639551 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A BACTEREMIA INFECTION ORIGINATING AS AN INFECTED INGROWN TOE NAIL. VEGETATION WAS OBSERVED ON THE DEVICE LEADS. INTRAVENOUS (IV) ANTIBIOTICS WERE ADMINISTERED TO THE PATIENT. 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: Bacteremia; Medical device site infection

  MAUDE report 24459193 ↗
• InjuryJan 21, 2026Premature 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 24131773 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED INFECTION. THE SYSTEM WAS EXPLANTED WITHOUT REPLACEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24033023 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EROSION. IT WAS NOTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS EXPOSED. THE 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

  MAUDE report 24006446 ↗
• MalfunctionNov 18, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT ATRIAL EVENTS APPEARED TO BE FALLING INTO THE BLANKING/REFRACTORY PERIOD AT TIMES, POSSIBLY TRIGGERING DEVICE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) CLASSIFIED TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DETECTED EVENTS AND RESULTING IN INAPPROPRIATE ATRIAL PACING. 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 23584514 ↗
• MalfunctionJul 31, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) THE SETSCREW COULD NOT BE ENGAGED AND WOULD NOT TURN. THE DEVICE WAS SWAPPED OUT FOR A DIFFERENT CRT-P. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22680821 ↗
• InjuryJul 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEPSIS, AND VEGETATION WAS OBSERVED ON THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis

  MAUDE report 22523727 ↗
• DeathJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 10 DAYS POST IMPLANTABLE PULSE GENERATOR (IPG) TO CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) UPGRADE, THE PATIENT PASSED AWAY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE; HOWEVER, THE PATIENT'S OBITUARY INDICATED THE PATIENT PASSED AWAY AFTER A LONG ILLNESS.

  Patient problems: Insufficient Information

  MAUDE report 22394191 ↗
• InjuryMay 8, 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) HAD ERODED AND WAS VISIBLE OUTSIDE THE BODY THREE MONTHS POST-IMPLANT. THE DEVICE SYSTEM WAS EXPLANTED AND A LEADLESS PACEMAKER WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 21983514 ↗
• MalfunctionApr 25, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT BY THE PATIENT'S SPOUSE THAT THEY WERE CONCERNED THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) MALFUNCTIONED AND THEY INQUIRED IF THE DEVICE WAS 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 21912643 ↗
• InjuryApr 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST REPLACEMENT PROCEDURE, THE PHYSICIAN SUSPECTS THAT THE PATIENT DEVELOPED A POCKET INFECTION. THE PATIENT PRESENTED FOR FOLLOW-UP ON THE RECENT CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WOUND INFECTION ON THE RIGHT PECTORAL REGION. THE PATIENT STATED A COUPLE WEEKS PRIOR THAT THEY NOTICED PURULENT DISCHARGE FROM THE RIGHT PECTORAL REGION AT THE DEVICE SITE. THE PATIENT WAS PRESCRIBED ANTIBIOTICS. IT WAS NOTED THAT THE SUPERFICIAL WOUND AT THE DEVICE SITE HEALED UP, BUT THE PATIENT WAS EXPERIENCING RIGORS AND CHILLS FOR SEVERAL DAYS, THEREFORE THE PATIENT PRESENTED FOR REEVALUATION. IT WAS NOTED THAT THERE WAS MILD FLUCTUATION IN SWELLING UPON PALPITATION AT THE RIGHT PECTORAL DEVICE SITE AND IT WAS WARM TO THE TOUCH. DURING THE REMOVAL PROCEDURE, PURULENT DISCHARGE WAS OBSERVED AFTER THE INCISION WAS MADE. THE PATIENT RECEIVED PRE-OPERATION PERIPHERAL INTRAVENOUS (IV) ANTIBIOTICS. THE RIGHT-SIDE CRT-P SYSTEM WAS REMOVED, AND THE POCKET WAS DEBRIDED AND WASHED WITH ANTIBIOTICS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM ON THE LEFT PECTORAL SITE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPOR

  Patient problems: Chills; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 21744108 ↗
• DeathFeb 25, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT'S FAMILY THAT THE PATIENTS HEART RATE WAS DECREASING AND THE PATIENT SUBSEQUENTLY PASSED AWAY. ADDITIONAL INFORMATION RECEIVED FROM THE CLINICIAN NOTED THE MANNER OF DEATH WAS NATURAL HOWEVER THE CAUSE WAS NOT PROVIDED. THE CLINICIAN ALSO NOTED THAT THE PATIENT WAS TO UNDERGO AN ATRIOVENTRICULAR (AV) NODE ABLATION BUT PASSED AWAY BEFORE THE PROCEDURE COULD TAKE PLACE. AT THE TIME OF DEATH THE PATIENT HAD AN IMPLANTED CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICE THAT DOES NOT PROVIDE TACHYARRHYTHMIA THERAPY.

  Patient problems: Insufficient Information

  MAUDE report 21463374 ↗
• InjuryJan 23, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIAPHRAGMATIC STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. THE PATIENT WAS ALSO EXPERIENCING DISCOMFORT AT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SITE DUE TO DEVICE MIGRATION TO THE ARMPIT. THE CRT-P AND THE LV LEAD WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort

  MAUDE report 21217886 ↗
• MalfunctionJan 8, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT COMPLAINED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS NOT FUNCTIONING AND FELT A DROP IN THEIR HEART RATE. IT WAS NOTED THAT THE PATIENT WAS HAVING VENTRICULAR TACHYCARDIA (VT). IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD HAD A POSITION CHECK FAILURE. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 21108027 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH A POSSIBLE INFECTION AND WAS DISCHARGED WITH ANTIBIOTICS. APPROXIMATELY SEVEN AND A HALF WEEKS LATER, THE PATIENT NOTED PUS COMING OUT OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) INCISION SITE AND THE FOLLOWING DAY IT WAS NOTED THAT THE PATIENT HAD AN INFECTION AND THE ORGANISM WAS IDENTIFIED AS STAPHYLOCOCCUS AUREUS. APPROXIMATELY SIX DAYS LATER, THE CRT-P SYSTEM WAS EXPLANTED AND A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Purulent Discharge; Unspecified Infection

  MAUDE report 21036603 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING SYMPTOMS OF ¿GETTING STUCK¿, WITH THEIR HEART RACING, BREATHING DIFFICULTY, CHEST TIGHTNESS, AND FEELING LIKE THEY WOULD LOSE CONTINENCE. ¿GETTING STUCK¿ WAS CLARIFIED TO MEAN THE PATIENT LITERALLY GETS STUCK AND CAN¿T MOVE OUT OF POSITION. THE SYMPTOMS WOULD OCCUR WITH VARIOUS ACTIVITIES SUCH AS REACHING OVERHEAD, STANDING UP FROM A SITTING POSITION, AND BENDING OVER. THE SYMPTOMS REPORTEDLY DATE BACK TWO YEARS. IT WAS REPORTED THAT THE PATIENT¿S RATE RESPONSIVE PACING SETTINGS HAD BEEN ADJUSTED FROM LOW TO MEDIUM A FEW WEEKS PRIOR. RESPONSE TO RATE AND EXERTION IN ADDITION TO ACTIVITIES OF DAILY LIVING WERE DISCUSSED. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Dyspnea

  MAUDE report 20923416 ↗

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