SPRINT QUATTRO SECURE S™ DXAC/DSP 693575 (UDI 00643169535923)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00643169535923), received between Nov 1, 2019 and Jan 8, 2026 — classified as 12 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Impedance Problem” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJan 8, 2026Fracture; High impedance; Impedance Problem; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT 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 24006017 ↗
• InjuryAug 6, 2025High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN OUT OF RANGE SPIKE IN PACING IMPEDANCE. 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 22726221 ↗
• InjuryMay 29, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE (OOR) HIGH PACING IMPEDANCE. 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 22111491 ↗
• InjuryNov 19, 2024Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SPIKE IN PACING IMPEDANCE. 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 20724135 ↗
• MalfunctionOct 31, 2024Activation, Positioning or Separation Problem; Positioning Problem; Activation, Positioning or Separation Problem; Positioning Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HELIX JUMPED DURING EXTENSION/RETRACTION. THE RV LEAD HELIX ALSO TOOK TOO MANY TURNS TO EXTEND/RETRACT. IT WAS ALSO NOTED THAT IT WAS DIFFICULT TO ADVANCE THE STYLET TO THE END OF THE LEAD. ULTIMATELY, THE LEAD WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582955 ↗
• MalfunctionOct 18, 2024Signal Artifact/Noise; Over-Sensing; Impedance Problem; Signal Artifact/Noise; Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED LEAD INTEGRITY ALERT (LIA) FOR ELEVATED SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED EPISODES. THE LEAD ALSO EXHIBITED OVERSENSING NOISE ON THE STORED ELECTROGRAMS (EGM) AND VARIATION IN RV LEAD 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 20486936 ↗
• InjurySep 11, 2024Fracture; Over-Sensing; Impedance Problem; Fracture; Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO SENSING INTEGRITY COUNTER (SIC) (SHORT V-V INTERVALS), HIGH-RATE NON-SUSTAINED EPISODES AND AN OUTSIDE TREND RVTIP TO RVCOIL IMPEDANCE MEASUREMENTS WHICH ALL WAS CONFIRMED DUE TO FRACTURE. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A GRADUAL IMPEDANCE RISE TO HIGH ON THE LV3 TO LV2 WHICH WAS SUSPECTED TO HAVE BEEN CAUSED BY MINERALIZATION OR TISSUE CHANGES. THE RV LEAD WAS REPROGRAMMED, AND LATER 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 20189004 ↗
• InjuryJul 18, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMP LICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19771997 ↗
• InjuryApr 2, 2024Signal Artifact/Noise; Fracture; Impedance Problem; Signal Artifact/Noise; Fracture; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE, AND WAS SUSPECTED FOR A FRACTURE. THE LEAD WAS EXPLANTED AND R EPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020884 ↗
• InjuryJan 25, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. 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 18580712 ↗
• MalfunctionJan 3, 2024High impedance; Over-Sensing; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A SUPERIOR VENA CAVA (SVC) LEAD IMPEDANCE WARNING DUE TO CHRONICALLY HIGH AND UNDEFINED MEASUREMENTS NOTED.  IT WAS NOTED THAT THE RV LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING.  IT WAS ALSO NOTED THAT THE LEFT VENTRICULAR (LV) LEAD APPEARS TO EXHIBIT A POSSIBLE INTERMITTENT LOSS OF BI-VENTRICULAR (BI-V) CAPTURE.  BOTH 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 18436672 ↗
• InjuryJul 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse 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 17325689 ↗
• InjuryJan 30, 2020Adverse 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), RIGHT ATRIAL (RA) LEAD, AND LEFT VENTRICULAR (LV) LEAD WERE REMOVED DUE TO AN INFECTION. IT WAS NOTED THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9647467 ↗
• InjuryJan 30, 2020Adverse 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), RIGHT ATRIAL (RA) LEAD, AND LEFT VENTRICULAR (LV) LEAD WERE REMOVED DUE TO AN INFECTION. IT WAS NOTED THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 9647448 ↗
• InjuryNov 1, 2019High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXPERIENCED HIGH THRESHOLD. THE RV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9267360 ↗