Sprint Quattro Secure MRI™ SureScan™ 6947M62 (UDI 00763000180324)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000180324), received between Dec 18, 2025 and Sep 4, 2026 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (2 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, 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Impedance Problem

  It was reported that the device was unable to be programmed to Magnetic Resonance Imaging (MRI) mode due to Out of Range (OOR) impedance values from the leads. The Right Ventricular (RV) lead and Left Ventricular (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 50616417 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Medical device site infection; Wound Dehiscence

  MAUDE report 50543815 ↗
• InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH AFTER THE IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM, THE SYSTEM WAS EXPLANTED AND SUBSEQUENTLY REPLACED DUE TO AN INFECTION. IT WAS NOTED THAT A TEMPORARY PACING LEAD WAS IMPLANTED AND THE TIME OF THE EXPLANT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25718699 ↗
• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A SYSTEMIC INFECTION. IT WAS NOTED THAT THE PATIENT HAD A FEVER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25279227 ↗
• InjuryMay 13, 2026Intermittent Capture; Positioning Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED INTERMITTENT CAPTURE. POSITIONING/ PLACEMENT ISSUES WERE NOTED WITH THE RV LEAD. IT WAS LATER REPORTED THAT THE RV LEAD WAS EXPLANTED AND REPLACED. THE LV 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 25166488 ↗
• MalfunctionMay 12, 2026Activation, Positioning or Separation Problem; Material Twisted/Bent

  IT WAS REPORTED THAT THERE WERE ANATOMY-RELATED DIFFICULTIES IN SECURING THE ATTEMPTED RIGHT VENTRICULAR (RV) LEAD IN THE TISSUE AND OBTAINING DESIRABLE ELECTRICAL NUMBERS. THE LEAD WAS REMOVED TO INSPECT IT FOR TISSUE OR CLOTS IN THE HELIX. NO SIGNIFICANT ISSUE WAS FOUND; HOWEVER, THE PHYSICIAN WAS UNABLE TO RETRACT THE HELIX PRIOR TO REINSERTION AND THE HELIX APPEARED TO BE SLIGHTLY BENT TO ONE SIDE.  THE PHYSICIAN'S STAFF WORKED ON THE ATTEMPTED LEAD FOR A WHILE AND WAS EVENTUALLY ABLE TO GET THE HELIX TO RETRACT BUT FELT THE HELIX MAY HAVE BEEN BENT DURING THE MULTIPLE INSERTION ATTEMPTS. A DIFFERENT LEAD WAS USED TO COMPLETE THE IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25151971 ↗
• MalfunctionMar 25, 2026Low impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED ALERTS FOR HIGH THRESHOLDS AND LOW RV PACING IMPEDANCE. 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 24688388 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RIGHT VENTRICLE CARDIAC PERFORATION AND PERICARDIAL EFFUSION. THE RV LEAD WAS RE-POSITIONED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 24606947 ↗
• InjuryFeb 24, 2026Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISLODGED APPROXIMATELY ONE WEEK POST-IMPLANT AND EXHIBITED HIGH CAPTURE THRESH OLDS. THE LEAD WAS REPOSITIONED 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 24430226 ↗
• MalfunctionDec 18, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT REPRESENTATIVE THAT ALERTS WERE BEING TRIGGERED MULTIPLE TIMES PER DAY. BASED ON THE CADENCE OF THE ALERTS A RIGHT VENTRICULAR (RV) LEAD ISSUE WAS SUSPECTED. THE RV 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 23837142 ↗