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

We found 2 models of Solara Quad CRT-P MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 242 adverse event reports in the FDA's MAUDE database, received between Oct 6, 2017 and Aug 30, 2026 — classified as 7 deaths, 158 injuries, 77 malfunctions.

The most frequently reported specific device problem is “Premature Discharge of Battery” (26 reports).

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

Most reported Solara Quad CRT-P MRI SureScan problems

Solara Quad CRT-P MRI SureScan models

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

• Solara™ Quad CRT-P MRI SureScan™ W4TR03

  Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  2 deaths140 reports
• Solara™ Quad CRT-P MRI SureScan™ W4TR03

  Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
  5 deaths102 reports

Recent Solara 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.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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