Sprint Quattro Secure S® 6935M55 (UDI 00643169309760)Recalls & reported problems

Summary

The FDA's MAUDE database contains 998 adverse event reports that list this exact device (DI 00643169309760), received between Aug 5, 2015 and Sep 24, 2026 — classified as 13 deaths, 657 injuries, 328 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (456 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 998 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889868 ↗
• MalfunctionSep 14, 2026Signal Artifact/Noise; Fracture; High impedance

  It was reported that the Right Ventricular (RV) lead exhibited a jump in pacing and defibrillation impedances, and a warning was triggered for high impedances. It was also reported that non-physiologic noise was observed on the electrograms (EGM), and a RV coil fracture 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 50759272 ↗
• MalfunctionSep 4, 2026Low impedance

  It was reported that the Right Ventricular (RV) lead triggered a warning for low Out of Range (OOR) pacing impedance. It was noted that the measurements were consistent with historical values. 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 50616586 ↗
• MalfunctionAug 27, 2026Fracture

  It was reported that the Right Ventricular (RV) lead was fractured. 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 50475583 ↗
• InjuryAug 25, 2026Fracture

  It was reported that the Right Ventricular (RV) lead had a suspected low voltage fracture. 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 50441805 ↗
• MalfunctionAug 14, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50250458 ↗
• InjuryAug 10, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that the Right Ventricular (RV) lead triggered a Lead Integrity Alert (LIA) due to high rate non sustained episodes, Sensing Integrity Counter (SIC) and lead noise. The RV lead was capped and remains in the patient. A new RV lead was implanted. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50200334 ↗
• InjuryJul 30, 2026High impedance

  It was reported that the Right Ventricular (RV) exhibited high shock impedances. The lead was subsequently 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 50084207 ↗
• InjuryJul 29, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  It was reported that the Right Ventricular (RV) lead triggered a Lead Integrity Alert (LIA) due to Sensing Integrity Counter (SIC) and High Rate Non-Sustained episodes. In addition both the RV and Right Atrial (RA) lead exhibited noise and oversensing. The patient received an inappropriate shock due to the noise and oversensing. It was also noted that the patient was in a swimming pool at the time of the LIA. The RV and RA 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 50077685 ↗
• MalfunctionJul 13, 2026Signal Artifact/Noise; Fracture; Impedance Problem; Unstable Impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES, NON PHYSIOLOGIC NOISE ON THE RV TIP TO RV RING ELECTROGRAMS (EGM), AS WELL AS RV TIP TO RV RING AND RV TIP TO RV COIL JUMPS AND VARIABILITY IN IMPEDANCES. THERE WAS A POTENTIAL FRACTURE NOTED. 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 25808646 ↗
• InjuryJun 29, 2026Signal Artifact/Noise; Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING AND NOISE WAS OBSERVED ON RV LEAD CHANNELS. ADDITIONALLY, THE RV LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED EPISODES AND ELEVATED SENSING INTEGRITY COUNTER (SIC). RISING RIGHT VENTRICULAR (RV) LEAD IMPEDANCE WAS ALSO OBSERVED. REPROGRAMMING WAS PERFORMED AND DETECTIONS WERE TURNED OFF BUT ALARMS WERE NOT TURNED OFF. THE RIGHT VENTRICULAR (RV) LEAD WAS PARTIALLY REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25660537 ↗
• MalfunctionJun 18, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED POSSIBLE 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 25549560 ↗
• MalfunctionJun 16, 2026Impedance Problem

  IT WAS REPORTED THAT A LEAD ALERT TRIGGERED DUE TO A GRADUAL INCREASE IN RIGHT VENTRICULAR (RV) DEFIBRILLATOR 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 25524427 ↗
• InjuryJun 15, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. 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 25509116 ↗
• DeathJun 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED A SUSPECTED INFECTION AND RECEIVED EXTENSIVE ANTIBIOTIC TREATMENT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR FURTHER MANAGEMENT BUT DID NOT SURVIVE. ADDITIONAL INFORMATION RELATED TO THE CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

  Patient problems: Unspecified Infection

  MAUDE report 25488294 ↗
• MalfunctionJun 9, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENTS IN PROGRESS AND UNNECESSARY PACING AT TIMES. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD WARNING FOR RV TIP TO RV COIL LEAD IMPEDANCE. THE RA LEAD AND 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 25449260 ↗
• InjuryMay 20, 2026Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED DUE TO CONFIRMED LOW VOLTAGE FRACTURE.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25233695 ↗
• InjuryMay 12, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED DUE TO AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25156352 ↗
• InjuryMay 11, 2026Fracture; High impedance

  IT WAS FURTHER REPORTED THAT THE RV LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137603 ↗
• MalfunctionMay 5, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR) THAT THE DEVICE DETECTED AS VENTRICULAR FIBRILLATION (VF). IN ADDITION, THER WAS T-WAVE OVERSENSING (TWOS) OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25083266 ↗
• MalfunctionMay 4, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A WARNING FOR LOW 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 25069130 ↗
• MalfunctionApr 28, 2026Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR LOW OUT OF RANGE (OOR) 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 25019078 ↗
• MalfunctionApr 23, 2026High Capture Threshold

  IT WAS REPORTED THAT THE DEVICE WIRELESS TELEMETRY WAS NOT AVAILABLE. IN ADDITION, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND 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 24971906 ↗
• InjuryApr 21, 2026Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD COIL WAS FRACTURED. 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 24941777 ↗
• InjuryApr 16, 2026Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD WERE SUSPECTED TO BE FRACTURED. THE LEADS WERE 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 24902329 ↗