Sprint Quattro Secure® DXAC/DSP 694775 (UDI 00613994740939)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00613994740939), received between Dec 9, 2016 and Mar 26, 2026 — classified as 1 death, 10 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED 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 24706742 ↗
• MalfunctionMar 26, 2026Under-Sensing

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE. ADDITIONALLY, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. THE LV 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 24706656 ↗
• InjuryAug 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A FRACTURED DEFIBRILLATION ELECTRODE AND HAD MALFUNCTIONED. THE LEAD WAS PARTIALLY 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 22773623 ↗
• InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 21158697 ↗
• MalfunctionJan 6, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT FOR CHEST PAIN. IT WAS NOTED ON THE TRANSMISSION THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, UNDEFINED PACING IMPEDANCE, HIGH RV DEFIBRILLATION IMPEDANCE, AND HIGH 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: Chest Pain

  MAUDE report 21082278 ↗
• InjuryMar 16, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED. 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 16553444 ↗
• InjuryMay 4, 2022Fracture; Inappropriate/Inadequate Shock/Stimulation; Fracture; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT WAS INAPPROPRIATELY SHOCKED BY THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS SUSPECT OF A FRACTURE. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 14284100 ↗
• MalfunctionNov 24, 2021Mechanical Problem; Stretched; Mechanical Problem; Stretched

  IT WAS REPORTED THAT SINCE THE TIME OF IMPLANT, THE RIGHT VENTRICULAR (RV) SHOCKING COIL HAS APPEARED STRETCHED UPON REVIEW OF A CHEST X-RAY. 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 12870209 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SEVEN MONTHS POST GENERATOR CHANGEOUT, THE PATIENT'S POCKET WOULD NOT HEAL AND AFTER A MONTH OF TREATMENT AN INFECTION DEVELOPED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND ANTIBIOTIC TREATMENT WAS NECESSARY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 12240023 ↗
• InjuryDec 11, 2019Signal Artifact/Noise; Over-Sensing; Difficult to Remove; Activation, Positioning or Separation Problem; Signal Artifact/Noise; Over-Sensing; Difficult to Remove; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE PATIENT¿S RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR ELEVATED SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED EPISODES. ADDITIONALLY, THE RV LEAD TRIGGERED A NOISE ALERT FOR OVERSENSING-NOISE EPISODES. A LASER EXTRACTION WAS ATTEMPTED; HOWEVER, THE HELIX WOULD NOT RETRACT, SO THE RV LEAD WAS CUT AND CAPPED IN THE POCKET. TWO DAYS LATER 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 9452406 ↗
• DeathJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING THEIR RIGHT VENTRICULAR (RV) LEAD ELECTIVELY REPLACED, BUT DURING THE PROCEDURE, THE EXTRACTION LASER PERFORATED THE SUPERIOR VENA CAVA AND THE PATIENT HAD AN ENORMOUS LOSS OF BLOOD AND THE PATIENT DIED.

  Patient problems: Death

  MAUDE report 8758781 ↗
• InjuryMay 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE ORGANISM WAS IDENTIFIED AS ENTEROCOCCUS FAECALIS BACTEREMIA. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) NOTED ARTIFACT VERSE VEGETATION ON THE RIGHT ATRIAL LEAD. ANTIBIOTIC TREATMENT WAS NECESSARY. THE DEVICE AND LEADS WERE EXPLANTED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8649378 ↗
• MalfunctionMay 23, 2019High impedance; Impedance Problem; High Capture Threshold; High impedance; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THERE WAS AN ALERT FOR HIGH UNDEFINED IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. THERE WAS ALSO STEADY IMPEDANCE AND ELEVATED THRESHOLD. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8638828 ↗
• InjuryNov 1, 2018Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD FRACTURED. THE LEAD HAD HIGH UNDEFINED IMPEDANCE ON THE SUPERIOR VENA CAVA (SVC) COIL. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8027221 ↗
• InjuryApr 10, 2018Failure to Capture; Fracture; High impedance; Over-Sensing; High Capture Threshold; Failure to Capture; Fracture; High impedance; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS, LOSS OF CAPTURE, HIGH AND UNDEFINED PACING IMPEDANCES AND OVERSENSING. A POSSIBLE LEAD FRACTURE WAS SUSPECTED. IT WAS NOTED THAT A LEAD INTEGRITY ALERT WAS TRIGGERED, A RV BIPOLAR LEAD IMPEDANCE ALERT WAS TRIGGERED, AND THAT THERE WAS A SENSING ISSUE DUE TO NUMBER OF SHORT V-V INTERVALS. THE RV LEAD WAS CAPPED 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 7414541 ↗
• MalfunctionOct 6, 2017Break; Break

  THE LEAD WAS RETURNED TO THE MANUFACTURER, IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. THE PATIENT IS DECEASED AND ADDITIONAL INFORMATION INDICATES THE DEATH WAS UNRELATED TO THE OUT OF SPECIFICATION FINDING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6919646 ↗
• MalfunctionAug 9, 2017Impedance Problem; Impedance Problem

  IT WAS REPORTED BY THE PATIENT THAT A PATIENT ALERT OCCURRED. ADDITIONAL INFORMATION WAS OBTAINED FROM THE CLINIC AND INDICATED THE ALERT WAS TRIGGERED DUE TO RISING RIGHT VENTRICULAR (RV) LEAD RV AND SUPERIOR VENA CAVA (SVC) IMPEDANCE. THE ALERT PARAMETERS WERE CHANGED AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6783599 ↗
• InjuryDec 9, 2016Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated; Inappropriate/Inadequate Shock/Stimulation; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED AND PULLED BACK INTO THE ATRIUM. THE LEAD THEN SENSED BOTH ATRIAL AND VENTRICULAR SIGNAL RESULTING IN INAPPROPRIATE SHOCKS. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 6160484 ↗