SPRINT QUATTRO SECURE S™ DXAC/DSP 693552 (UDI 00643169535893)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169535893), received between Feb 9, 2021 and Sep 11, 2025 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THERE A POSSIBLE SINGLE UNDERSENSED BEAT PRIOR TO VENTRICULAR FIBRILLATION (VF) DETECTION ON THE RIGHT VENTRICULAR (RV) LEAD. IT DOES NOT APPEAR TO HAVE IMPACTED DETECTION. 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 23030936 ↗
• MalfunctionJun 25, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). 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 22331300 ↗
• InjuryJul 22, 2024Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Low impedance; Impedance Problem; Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Low impedance; Impedance Problem

  IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED HIGH PACING AND SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE MEASUREMENTS. THE 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 19802561 ↗
• InjuryMar 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. SWELLING, REDNESS, AND DISCOMFORT WERE ALSO NOTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Swelling/ Edema; Unspecified Infection

  MAUDE report 18941440 ↗
• InjuryFeb 23, 2024Signal Artifact/Noise; Break; Over-Sensing; Signal Artifact/Noise; Break; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL DUE TO THE DEVICE ALERTING. DEVICE INTERROGATION SHOWED A LEAD INTEGRITY ALERT (LIA) OCCURRED, OVERSENSING, SENSING INTEGRITY COUNTER (SIC), AND MIRROR IMAGE NOISE WAS SEEN ON BOTH THE TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD AND EPICARDIAL RV LEAD. THERE WAS AN INSULATION BREACH ON BOTH LEADS AND IT WAS NOTED THAT THE RVRING AND RVCOIL CONDUCTORS WERE MAKING CONTACT DUE TO THE BREACH. THE LEADS WERE 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 18767254 ↗
• MalfunctionMay 18, 2023Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) PACE/SENSE LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). STORED ELECTROGRAMS (EGM) SHOWED OVERSENSING AND NOISE ON THE RV DEFIBRILLATION LEAD AND THE RV PACE/SENSE LEAD. THE PATIENT PERFORMED ISOMETRICS AND COULD NOT RECREATE THE NOISE. 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 16954914 ↗
• InjuryNov 8, 2022Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT HAD SYNCOPE. IT WAS FOUND THAT THERE WERE INFREQUENT DROP OUT BEATS DURING VENTRICULAR FIBRILLATION (VF) DETECTION. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 15752660 ↗
• InjuryMar 3, 2021Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE LEAD ALERT TRIGGERED, AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH/UNDEFINED DEFIBRILLATION COIL IMPEDANCE. A FRACTURE OF THE COIL WAS SUSPECTED, AND THE LEAD WAS SUBSEQUENTLY EXPLANTED AND REPLACED. THE LEAD WAS CUT DURING THE REMOVAL PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11405192 ↗
• InjuryFeb 9, 2021High impedance; High impedance

  IT WAS FURTHER REPORTED THROUGH FOLLOW-UP INVESTIGATION THAT THE SVC HAD INADVERTENTLY BEEN LEFT 'ON' WHICH CAUSED THE HIGH IMPEDANCE ISSUE. THE SVC COIL WAS PROGRAMMED TO 'OFF', AND THE VALUES RETURNED TO NORMAL. THE LEAD REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11301753 ↗