Sprint Quattro Secure S® 6935M62 (UDI 00643169309777)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,731 adverse event reports that list this exact device (DI 00643169309777), received between Feb 10, 2015 and Sep 30, 2026 — classified as 33 deaths, 1,037 injuries, 661 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (744 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 1,731 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951539 ↗
• MalfunctionSep 25, 2026Unstable Capture Threshold

  It was reported that there were two Right Ventricular (RV) lead threshold measurements outside the expected range but still within the programmed output. 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 50897754 ↗
• MalfunctionSep 24, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) lead triggered a Lead Integrity Alert (LIA) due to increased Sensing Integrity Counter (SIC) and two or more High Rate-Non Sustained episodes. 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 50883105 ↗
• InjurySep 18, 2026High impedance; Difficult to Remove; Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831255 ↗
• InjurySep 18, 2026Fracture; High impedance; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829064 ↗
• InjurySep 14, 2026Capturing Problem; Impedance Problem; High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited rising defibrillation impedance and rising and high RV thresholds. 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 50752562 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted and replaced due to an infection with Endocarditis. No further patient complications have been reported as a result of this event.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 50716989 ↗
• MalfunctionSep 8, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50676416 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient had an episode of confusion lasting approximately an hour and a half resulting in an emergency department evaluation with brain imaging indicating that the patient had a "mini stroke". It was also noted that the patient had an intracardiac blood clot after surgery that was evaluated with a transesophageal stud believed to be a thrombus on the Right Ventricular (RV) lead and was prescribed a blood thinner used to treat and prevent dangerous blood clots. The thrombus was confirmed to be resolved sometime later and the patient was taken off the blood thinner. The lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Confusion/ Disorientation; Thrombosis/Thrombus

  MAUDE report 50551044 ↗
• InjuryAug 25, 2026Fracture

  It was reported that the Right Ventricular (RV) lead had a suspected RV coil fracture. 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 50439945 ↗
• InjuryAug 24, 2026Fracture; Unstable Impedance

  It was reported that the patient was involved in a car accident and stated that the steering wheel hit their chest and device. Approximately 1 month later, the Right Ventricular (RV) lead showed signs of possible fracture with varying impedances. The RV lead was extracted and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50422004 ↗
• MalfunctionAug 19, 2026Signal Artifact/Noise; High impedance; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50330306 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted due to infection. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50325640 ↗
• MalfunctionAug 10, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS). 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 50198335 ↗
• MalfunctionAug 6, 2026Low impedance

  It was reported that the Right Ventricular (RV) lead exhibited low pacing impedance. Additionally, it was noted that the patient exp erienced dizziness, frequent falls, and confusion. The RV lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Confusion/ Disorientation; Dizziness; Fall

  MAUDE report 50164213 ↗
• InjuryJul 31, 2026Fracture; High impedance; High Capture Threshold

  It was reported that the patient had broken through a picnic chair and a family member had to ¿grab him by the left arm forcibly¿ to try and help. The Right Ventricular (RV) lead triggered alerts for undefined high RV defibrillation coil impedance and RV pacing impedance values. It was also noted that a few years ago the lead triggered an alert for high thresholds. The lead was suspected of having a high voltage RV coil fracture and the physician reprogrammed detections off. 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 50102333 ↗
• MalfunctionJul 28, 2026High impedance; Unstable Capture Threshold; Unstable Impedance

  Patient problems: Anxiety; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50057341 ↗
• MalfunctionJul 13, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25797365 ↗
• InjuryJul 7, 2026Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCES, HIGH OUT OF RANGE RV DEFIBRILLATION COIL IMPEDANCES, AND A SPIKE IN RV DEFIBRILLATION COIL IMPEDANCES. A LEAD FRACTURE WAS SUSPECTED. THE RV LEAD VENTRICULAR TACHYCARDIA (VT)/VENTRICULAR FIBRILLATION (VF) DETECTIONS WERE PROGRAMMED OFF. APPROXIMATELY ONE WEEK LATER, THE RV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25737582 ↗
• MalfunctionJun 26, 2026Under-Sensing

  IT WAS REPORTED THAT THERE WAS UNDERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. 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 25642173 ↗
• MalfunctionJun 25, 2026Intermittent Capture; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND IT WAS UNABLE TO BE CONFIRMED THAT THE CURRENT OUTPUT WAS SUFFICIENT FOR CONSISTENT CAPTURE. 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 25622981 ↗
• InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SYSTEM WAS EXPLANTED DUE TO A BACTEREMIA INFECTION. FEVER AND REDNESS WERE NOTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Erythema; Fever

  MAUDE report 25622076 ↗
• MalfunctionJun 23, 2026Under-Sensing

  IT WAS REPORTED THAT THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. 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 25598907 ↗
• MalfunctionJun 23, 2026Pacing Problem; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING IN INAPPROPRIATE PACING. THE LEAD REMAINS IN U SE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25597000 ↗
• MalfunctionJun 22, 2026Failure to Capture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE (OOR) HIGH PACING IMPEDANCE, HIGH THRESHOLD AND NO SENSING INTEGRITY COUNTER (SIC) AND NO 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 25588344 ↗