Sprint Quattro Secure® DXAC/DSP 694765 (UDI 00613994740922)Recalls & reported problems

Summary

The FDA's MAUDE database contains 852 adverse event reports that list this exact device (DI 00613994740922), received between Aug 9, 2016 and Sep 25, 2026 — classified as 10 deaths, 517 injuries, 325 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (340 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 852 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem; Connection Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902659 ↗
• InjurySep 11, 2026Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Unstable Impedance

  It was reported that the Right Ventricular (RV) lead triggered a Lead Integrity Alert (LIA) for high rate non sustained episodes, RV Bipolar and RVtip to RVcoil high impedance, Sensing Integrity Counter (SIC) and impedance variation.  It was also reported that the RV lead exhibited non physiologic noise and probable RVtip conductor, RV Coil, SVC Coil fracture suspected.  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 50736987 ↗
• MalfunctionSep 8, 2026Signal Artifact/Noise; Over-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 also exhibited noise. 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 50671179 ↗
• InjurySep 2, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50569149 ↗
• InjurySep 1, 2026Fracture; Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited oversensing resulting in non-physiologic intervals and triggered a Lead Integrity Alert (LIA) due to High Rate Non-Sustained episodes and Sensing Integrity Counter (SIC). It was further reported that the lead had a suspected high voltage fracture. The 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 50547175 ↗
• MalfunctionAug 26, 2026High impedance

  It was reported that there was high undefined Superior Vena Cava (SVC) coil impedance on the Right Ventricular (RV) lead. 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 50455660 ↗
• InjuryAug 3, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 50122709 ↗
• InjuryJul 30, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) lead  had triggered Lead Integrity Alert (LIA) for elevated Sensing Integrity Counter (SIC) and High Rate Non-Sustained episodes. The RV lead exhibited oversensing.  Trouble shooting and and reprogramming was performed but the RV lead triggered LIA again. 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 50086716 ↗
• InjuryJul 29, 2026Low impedance

  It was reported that the Right Ventricular (RV) lead exhibited low Out of Range (OOR) pacing impedance. 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 50077696 ↗
• InjuryJun 26, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED. THE REASON FOR EXPLANT WAS NOT REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25643368 ↗
• MalfunctionJun 12, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING TRIGGERED ATRIAL TACHYCARDIA/ATRIAL FI BRILLATION (AT/AF) MISCLASSIFICATION AND ANTI-TACHYCARDIA PACING (ATP). THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. THE RA AND RV 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 25488167 ↗
• MalfunctionJun 8, 2026Low impedance

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY AND INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AS VENTRICULAR TACHYCARDIA (VT). ADDITIONALLY, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW PACING IMPEDANCE. THE ICD AND RV 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 25430213 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION. ADDITIONALLY, THE PATIENT EXPERIENCED SWELLING AND WOUND DEHISCENCE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection; Swelling/ Edema; Wound Dehiscence

  MAUDE report 25321415 ↗
• InjuryApr 29, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT DURING USE OF THE RIGHT VENTRICULAR (RV) LEAD, NOISE WAS NOTED DURING VENTRICULAR TACHYCARDIA (VT) MONITORED EPISODES. 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 25034137 ↗
• MalfunctionApr 29, 2026Signal Artifact/Noise; High impedance; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR ELEVATED SENSING INTEGRITY COUNTER (SIC), ELEVATED PACING IMPEDANCE, AND OVERSENSING RESULTING IN INHIBITION OF PACING AND MISCLASSIFICATION OF EPISODE TYPE, AND NOISE. 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 25033270 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV), RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) LEADS WERE EXPLANTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25008096 ↗
• MalfunctionApr 24, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA (AT)/ATRIAL FIBRILLATION (AF) RESULTING IN INAPPROPRIATE ATRIAL PACING. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE INAPPROPRIATE ATRIAL PACING RESULTED IN VENTRICULAR EVENTS FALLING IN BLANKING PERIOD OR POSSIBLE RIGHT VENTRICULAR (RV) LEAD UNDERSENSING. THE RV LEAD REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24983523 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POCKET HAD WOUND DEHISCENCE AND WAS OOZING WITH PUS. THE PATIENT EXPERIENCED INFECTION, DISCOMFORT, EROSION, REDNESS AND SWELLING. THE CRT-D SYSTEM WAS EXPLANTED AND REPLACED WITH A TEMPORARY EXTERNAL IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM SO THE PATIENT COULD RECOVER FROM THE INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Medical device site infection; Pocket Erosion; Purulent Discharge; Wound Dehiscence

  MAUDE report 24841813 ↗
• MalfunctionMar 25, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT¿S SPOUSE THAT THEY WERE HEARING THE HIGH/LOW PATIENT ALERT TONE EVERY FOUR TO SIX HOURS. TONING EVERY FOUR HOURS IS TYPICALLY INDICATIVE OF A RIGHT VENTRICULAR (RV) LEAD INTEGRITY ALERT. 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 24689644 ↗
• InjuryMar 24, 2026Unstable Impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED VARYING 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 24674401 ↗
• MalfunctionMar 20, 2026Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A STEADY INCREASE IN IMPEDANCE VALUES AND 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 24650151 ↗
• MalfunctionMar 19, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR UNDEFINED HIGH 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 24643295 ↗
• MalfunctionMar 19, 2026Pacing Problem; Under-Sensing

  IT WAS ALSO NOTED THAT THE RV UNDERSENSING RESULTED IN UNNECESSARY PACING. IT WAS FURTHER REPORTED WAS RA LEAD UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENTS IN PROGRESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24642894 ↗
• MalfunctionMar 19, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SINGULAR UNDERSENSED VENTRICULAR BEAT. 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 24642673 ↗
• InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION AND POCKET EROSION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 24641881 ↗