Sprint Quattro Secure® DXAC/DSP 694758 (UDI 00613994740915)Recalls & reported problems

Summary

The FDA's MAUDE database contains 421 adverse event reports that list this exact device (DI 00613994740915), received between Dec 9, 2016 and Sep 9, 2026 — classified as 3 deaths, 278 injuries, 140 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (165 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 421 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) lead triggered a Lead Integrity Alert (LIA) for High Rate Non-Sustained episodes and Sensing Integrity Counter (SIC). 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 50696417 ↗
• MalfunctionSep 1, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50545180 ↗
• MalfunctionAug 27, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that the Right Ventricular (RV) lead triggered a Lead Integrity Alert (LIA) for high-rate non-sustained episodes and Sensing Integrity Counter (SIC). The RV lead also exhibited oversensing and non-physiologic intervals/noise. 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 50479053 ↗
• MalfunctionAug 26, 2026Under-Sensing

  It was further reported that the patient had a heart transplant and the Implantable Cardioverter Defibrillator (ICD) system was explanted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50462135 ↗
• MalfunctionJul 10, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT WAS HEARING AN ALERT TONE EVERY FOUR HOURS, INDICATIVE OF A POSSIBLE LEAD INTEGRITY ISSUE. THE RIGHT VENTRICULAR (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 25785288 ↗
• InjuryJun 9, 2026Signal Artifact/Noise; Failure to Capture; Fracture; High impedance; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA, DIZZINESS, AND SYNCOPE AND WAS HOSPITALIZED. THE RV LEAD EXHIBITED LEAD INTEGRITY ALERT (LIA) WARNING FOR NON SUSTAINED EPISODES WITH POSSIBLE NOISE. IT WAS ALSO REPORTED THAT THE RV LEAD EXHIBITED HIGH IMPEDANCE, NO PACING NOTED IN TRUE BIPOLAR OR TIP TO COIL PACING ATTEMPTS DUE TO OVERSENSING AND SUSPECTED FRACTURE. DEVICE SETTINGS WERE RE-PROGRAMMED WITH DETECTIONS OFF. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia; Dizziness; Syncope/Fainting

  MAUDE report 25443325 ↗
• MalfunctionMay 12, 2026Capturing Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A GRADUAL DECLINE IN PACING IMPEDANCE AND RV AND SUPERIOR VENA CAVA (SVC) DEFIBRILLATION IMPEDANCE. THERE WAS ALSO A GRADUAL INCREASE IN CAPTURE THRESHOLD. 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 25156275 ↗
• MalfunctionMay 5, 2026High impedance

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PALPITATIONS AND THE RIGHT VENTRICULAR (RV) LEAD HAD TRIGGERED ALERTS DUE TO HIGH, OUT-OF-RANGE SUPERIOR VENA CAVA (SVC) DEFIBRILLATION IMPEDANCE. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Palpitations

  MAUDE report 25081149 ↗
• MalfunctionApr 30, 2026Under-Sensing; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT UNDERSENSING DURING A VENTRICULAR ARRHYTHMIA, POST-DETEC TION OF ARRHYTHMIA. THE DEVICE DELIVERED APPROPRIATE THERAPY. THE RV LEAD ALSO TRIGGERED AN ALERT DUE TO LOW, OUT-OF-RANGE 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 25044713 ↗
• InjuryApr 28, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH VOLTAGE (HV) NOISE. 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 25019389 ↗
• MalfunctionMar 6, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING ON STORED 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 24534863 ↗
• MalfunctionFeb 24, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) POST VENTRICULAR SENSE. 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 24434662 ↗
• MalfunctionFeb 18, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED CHRONIC RV HIGH THRESHOLD. 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 24379264 ↗
• InjuryFeb 18, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH/UNDEFINED SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE. IT WAS ALSO REPORTED THAT A PATIENT REPRESENTATIVE NOTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS ¿FLAWED.¿ THE RV LEAD AND ICD 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 24379031 ↗
• InjuryFeb 11, 2026Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING AND HIGH 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 24315369 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Bacteremia; Fungal Infection; Medical device site infection; Sepsis; Unspecified Infection

  MAUDE report 24314824 ↗
• InjuryFeb 9, 2026High 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 24293114 ↗
• InjuryJan 29, 2026Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE EPICARDIAL RIGHT VENTRICULAR (RV) LEAD EXHIBITED A FLUCTUATION IN IMPEDANCES. THE RV DEFIBRILLATION, SUPERIOR VENA CAVA (SVC) COIL, AND RV PACING IMPEDANCES WERE UNDEFINED HIGH OUT OF RANGE. DURING THE SYSTEM CHANGEOUT, THE RV LEAD WAS FOUND TO HAVE A COIL FRACTURE. 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 24215337 ↗
• InjuryJan 28, 2026Over-Sensing; Impedance Problem

  IT WAS FURTHER REPORTED THAT TACHYARRHYTHMIA THERAPIES WERE TURNED OFF AND THE LEAD WILL BE MONITORED UNTIL THE PATIENT'S NEXT FOLLOW-UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199825 ↗
• MalfunctionDec 17, 2025Defibrillation/Stimulation Problem; Low impedance; Defibrillation/Stimulation Problem; Low impedance

  IT WAS REPORTED THAT FOLLOWING A PHYSICAL ALTERCATION AND A FALL THE PATIENT RECEIVED INAPPROPRIATE SHOCKS FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT NOTED DISCOMFORT AND A JERKING FEELING IN THEIR CHEST. UPON REVIEW OF THE EPISODES, IT WAS ALSO NOTED THAT SHORT CIRCUIT PROTECTION (SCP) OCCURRED RESULTING IN LESS THAN PROGRAMMED HIGH VOLTAGE ENERGY DELIVERY FOR ALL SIX SHOCKS PROVIDED. IT COULD NOT BE DETERMINED WHETHER THE ICD OR RIGHT VENTRICULAR (RV) LEAD WAS RESPONSIBLE FOR THE SCP. OUT OF RANGE (OOR) LOW IMPEDANCE WAS ALSO OBSERVED ON THE RV LEAD DEFIBRILLATION AND SUPERIOR VENA CAVA (SVC) COILS. THE RV LEAD REMAINS IN USE AND THE ICD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828640 ↗
• MalfunctionDec 17, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR OUT OF RANGE (OOR) 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 23827699 ↗
• MalfunctionDec 10, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLY INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH-VOLTAGE THERAPY FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). ADDITIONALLY, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RARE UNDERSENSING NOTED ON A STORED EPISODE. THE 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 23771559 ↗
• InjuryDec 4, 2025Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED ALERTS FOR UNDEFINED HIGH OUT OF RANGE (OOR) BIPOLAR AND TIP TO COIL PACING IMPEDANCES, NOISE, AND A LEAD INTEGRITY ALERT (LIA) FOR HIGH RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC)COUNTS. 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 23715929 ↗
• InjuryNov 17, 2025Fracture; High impedance; Impedance Problem; Fracture; High impedance; Impedance Problem

  IT WAS FURTHER REPORTED THAT THE RV LEAD EXHIBITED MULTIPLE SPIKES IN PACING IMPEDANCE A YEAR AND A HALF PRIOR TO THE LEAD BEING CAPPED. AN RV LEAD FRACTURE WAS SUSPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23569244 ↗
• InjuryOct 31, 2025High impedance; Impedance Problem; Unstable Impedance; High impedance; Impedance Problem; Unstable Impedance

  IT WAS REPORTED THAT A LEAD IMPEDANCE WARNING TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD DUE TO A SPIKE TO UNDEFINED, HIGH SUPERIOR VENA CAVA (SVC) IMPEDANCE. THE SVC COIL WAS PROGRAMMED OFF, AND THE LEAD REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23438972 ↗