Sprint Quattro Secure S MRI™ SureScan™ 693565 (UDI 00643169690042)Recalls & reported problems

Summary

The FDA's MAUDE database contains 695 adverse event reports that list this exact device (DI 00643169690042), received between Feb 9, 2017 and Sep 30, 2026 — classified as 8 deaths, 387 injuries, 300 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (238 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 25 most recent of 695 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951293 ↗
• MalfunctionSep 29, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50934523 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Medical device site infection; Wound Dehiscence

  MAUDE report 50827028 ↗
• MalfunctionSep 15, 2026Over-Sensing; Under-Sensing

  It was reported that the Right Ventricular (RV) lead triggered a Lead Integrity Alert (LIA) due to the High-Rate Non-Sustained episodes and Sensing Integrity Counter (SIC). The lead exhibited T-Wave Oversensing (TWOS) post sense and under sensing. 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 50776056 ↗
• InjurySep 8, 2026Fracture; High impedance; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Unstable Impedance

  It was reported that the Right Ventricular (RV) lead triggered a Lead Integrity Alert (LIA) for high rate non-sustained episodes and Sensing Integrity Counter (SIC). The RV lead also exhibited oversensing and varying pacing impedance. The RV lead later triggered a warning for high Out of Range (OOR) pacing impedance. A fracture was confirmed on the RV lead. It was also noted that the patient receive inappropriate high voltage therapy from the RV lead. The RV lead was programmed off and the patient was sent home with a wearable defibrillator vest. The RV lead was later was capped and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50673754 ↗
• MalfunctionSep 5, 2026Low impedance; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50625498 ↗
• MalfunctionAug 31, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited oversensing post-ventricular pace. 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 50517839 ↗
• MalfunctionAug 27, 2026Over-Sensing; Connection Problem

  It was reported that the clinician noted an issue with over-sensing in the patient's defibrillator.  A review of device data indicated what appears to be possible Electromagnetic Interference source or lead/device connection issue as device was implanted less than a month prior.   The Implantable Cardioverter Defibrillator (ICD), Right Atrial (RA) lead and Right Ventricular (RV) 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 50483159 ↗
• MalfunctionAug 20, 2026Low impedance

  It was reported that the Right Ventricular (RV) lead triggered an alert for low Out of Range (OOR) pacing impedance. 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 50350572 ↗
• InjuryAug 19, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the Implantable Cardioverter Defibrillator (ICD) delivered inappropriate therapy for Supra Ventricular Tachycardia (SVT) detected as Ventricular Tachycardia (VT). It was observed that there was myopotential noise on the Right Ventricular (RV) lead during the episode. The RV lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50331339 ↗
• MalfunctionAug 19, 2026Impedance Problem

  It was reported that the Right Ventricular (RV) lead exhibited a rise in bipolar 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 50318299 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) patient experience an sepsis and bacteremia infection with valvular vegetations. The organism was stated to be enterococcus faecalis and the source of the infection was the tricuspid valve. The device system was explanted.  No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Medical device site infection; Sepsis

  MAUDE report 50256687 ↗
• MalfunctionAug 14, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50253825 ↗
• InjuryJul 30, 2026Over-Sensing

  It was reported that the Right Atrial (RA) and Right Ventricular (RV) leads exhibited oversensing resulting in non-physiologic intervals and false arrhythmia detection resulting in one shock delivered. It was further reported that the RA lead exhibited high thresholds. The leads remain in use. No further patient complications have been reported as a result of this event.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50086561 ↗
• InjuryJul 29, 2026Over-Sensing; Under-Sensing

  It was reported that Right Ventricular (RV) and Right Atrial (RA) lead undersensing and RV lead oversensing was noted on stored episodes of a remote transmission. The 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 50069890 ↗
• InjuryJul 7, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS "FAULTY". THE LEAD 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 25738605 ↗
• MalfunctionJul 6, 2026Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. 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 25718450 ↗
• InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN UNSPECIFIED INFECTION AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25561797 ↗
• InjuryJun 9, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS FURTHER REPORTED THAT THE PATIENT REPORTED "FEELING WEAK, THEN FELL TO THEIR KNEES AND THEN GOT A SHOCK".

  Patient problems: Dizziness; Muscle Weakness/Atrophy; Pain; Shock from Patient Lead(s)

  MAUDE report 25450611 ↗
• MalfunctionJun 2, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT DUE TO HIGH OUT OF RANGE (OOR) DEFIBRILLATION IMPEDANCE. 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 25368741 ↗
• MalfunctionJun 1, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. 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 25355844 ↗
• InjuryMay 14, 2026Signal Artifact/Noise; Fracture; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A POSSIBLE LEAD FRACTURE. THE LEAD EXHIBITED OVERSENSING, NOISE, OVERSENSING MYOPOTENTIALS, T-WAVE OVERSENSING (TWOS) AND TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES AND NON-PHYSIOLOGIC SENSING INTEGRITY COUNTER (SIC). THERAPIES AND DETECTION WERE DISABLED AND THE LEAD WAS LATER 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 25172235 ↗
• MalfunctionMay 5, 2026Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE. 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 25083558 ↗
• InjuryApr 20, 2026Fracture

  IT WAS REPORTED THAT THERE WAS A SUSPECTED HIGH VOLTAGE FRACTURE OF THE RIGHT VENTRICULAR (RV) LEAD. THE RV LEAD 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 24931439 ↗
• InjuryApr 8, 2026Over-Sensing; Defibrillation/Stimulation Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING IN NON-PHYSIOLOGIC INTERVALS AND UNDERSENSING BEFORE VENTRICULAR FIBRILLATION (VF) DETECTION RESULTING IN DELAY OF EPISODE DETECTION. IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS PREVIOUSLY REPROGRAMMED DUE TO PHRENIC STIMULATION. THE LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 24817652 ↗