Sprint Quattro® 6944-65 (UDI 00613994249975)Recalls & reported problems

Summary

The FDA's MAUDE database contains 492 adverse event reports that list this exact device (DI 00613994249975), received between Feb 8, 2014 and Sep 11, 2026 — classified as 5 deaths, 317 injuries, 170 malfunctions.

The most frequently reported specific device problem is “High impedance” (215 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 492 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026High impedance; Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited high Out of Range (OOR) pacing impedance and sudden triggering of Sensing Integrity Counter (SIC) counters. The pace/sense portion of the RV was replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50725581 ↗
• InjuryAug 7, 2026Break; Difficult to Remove

  It was reported that during an elective Implantable Cardioverter Defibrillator (ICD) system explant procedure, a pocket infection was noted with purulent discharge/pus and swelling. The ICD was explanted and the lead was unable to be fully extracted as it broke during explant attempt. No further patient complications have been reported as a result of this event.

  Patient problems: Medical device site infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 50176402 ↗
• InjuryJul 30, 2026High impedance; Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited high undefined pacing impedance and short ventricular intervals. Alerts and tachyarrhythmia therapies were noted to be programmed off. The lead remains in situ. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50085734 ↗
• MalfunctionJun 25, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NON-PHYSIOLOGIC INTERVALS/NOISE AND OVERSENSING RESULTING IN INHIBITION OF PACING. 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 25622174 ↗
• MalfunctionJun 2, 2026Failure to Capture; High impedance; Positioning Problem

  IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHANGEOUT PROCEDURE, THE PHYSICIAN OPENED THE POCKET AND NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD WERE ENTANGLED/KNOTTED UP AROUND THEMSELVES AND THE DEVICE. THE PHYSICIAN UNTANGLED THE LEADS. THE LEADS WERE DISCONNECTED FROM THE DEVICE AND PLUGGED BACK IN. HOWEVER, SUPERIOR VENA CAVA (SVC) IMPEDANCE WAS THEN UNABLE TO BE MEASURED AND THE RV COIL HAD HIGH IMPEDANCE. THE RV LEAD WAS AGAIN DISCONNECTED FROM THE DEVICE AND RECONNECTED TO THE HEADER AND NORMAL IMPEDANCE VALUES WERE MEASURED. AFTER THE DEVICE WAS PLACED INTO THE POCKET, IMPEDANCE WAS MEASURED AND SHOWED HIGH DEFIBRILLATION IMPEDANCE FOR THE RV AND SVC COILS AND NO CAPTURE ON THE RV LEAD. THE PHYSICIAN ELECTED TO NOT REVISE THE LEAD AT THE TIME OF THE PROCEDURE AND LEAVE DETECTIONS AND THERAPIES ON. 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 25364371 ↗
• MalfunctionMay 22, 2026Decreased Sensitivity; Capturing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING CAPTURE THRESHOLDS AND DIMINISHED R WAVE SENSING. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS. 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 25255420 ↗
• MalfunctionMay 13, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING WITH NO OBSERVED IMPACT TO OVERALL DEVICE FUNCTION OR PERFORMANCE. THE RV LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE THERAPY AND ANTI-TACHYCARDIA PACING (ATP) FOR SUSPECTED ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT). THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAINS 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 25163056 ↗
• InjuryApr 30, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEIR RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS WERE INACTIVATED DUE TO A "SHORTAGE OF THE WIRES". NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25050612 ↗
• MalfunctionApr 27, 2026High impedance; Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBIT T-WAVE OVERSENSING (TWOS) ON A STORED EPISODE. IT WAS NOTED THAT THE SAME EPISODE WAS REVIEWED FOR UNDERSENSING. IT WAS ALSO NOTED THAT THE RV LEAD HAD A PACING LEAD IMPEDANCE WARNING DUE TO HIGH AND UNDEFINED IMPEDANCE MEASUREMENT. 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 25000600 ↗
• InjuryApr 27, 2026Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A SUSPECTED 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 25000112 ↗
• InjuryApr 14, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED ELEVATED DEFIBRILLATION IMPEDANCE, AND THERE WAS AN RV TIP TO RV COIL IMPEDANCE WARNING. 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 24877875 ↗
• InjuryApr 9, 2026Signal Artifact/Noise; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND NOISE AND WAS REPROGRAMMED. 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 24830319 ↗
• MalfunctionMar 10, 2026Over-Sensing

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE THERAPY DUE TO OVERSENSING OF NOISE AND ELECTROMAGNETIC INTERFERENCE POSSIBLY DUE TO AN IMPROPERLY GROUNDED ELECTRIC COOKTOP. IT WAS FURTHER 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 DEVICE AND LEAD REMAINS 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 24563245 ↗
• MalfunctionMar 10, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) POST SENSED BEAT THAT WAS NOTED ON NON-SUSTAINED VENTRICULAR TACHYCARDIA. THE LEAD ALSO EXHIBITED ELEVATED 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 24563011 ↗
• InjuryFeb 19, 2026Signal Artifact/Noise; Fracture; High impedance; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCES AND NOISE. THE PATIENT RECEIVED MULTIPLE SHOCKS DUE TO THE NOISE. A LOW VOLTAGE LEAD FRACTURE WAS SUSPECTED. THE RV LEAD WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24390850 ↗
• MalfunctionFeb 18, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS. 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 24380242 ↗
• InjuryFeb 16, 2026Capturing Problem

  IT WAS REPORTED THAT THERE WAS INITIALLY A SUSPECTED INSULATION BREACH, POSSIBLY FROM CLAVICLE CRUSH, ON THE RIGHT VENTRICULAR (RV) LEAD, AS THE PATIENT EXPERIENCED PAIN, DISCOMFORT IN THE CHEST AND NECK, THROAT PRESSURE, AND STIMULATION IN THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POCKET AREA IN RESPONSE TO RV-ONLY PACING. A PRIOR SPIKE IN AND RECENT INCREASE IN CAPTURE THRESHOLDS WAS NOTED ON THE RV LEAD. THE PATIENT WAS NOT SYMPTOMATIC WHEN PROGRAMMED TO DUAL CHAMBER PACING. WITH FURTHER TESTING, IT WAS DETERMINED THAT THE PATIENT WAS SYMPTOMATIC AND EXPERIENCING PACEMAKER SYNDROME WITH VENTRICLE-ONLY PACING WHICH HAD BEEN TRIGGERED WHEN THE ICD HAD REACHED THE RECOMMENDED REPLACEMENT TIME (RRT). THE ELECTROPHYSIOLOGIST CONCLUDED THERE WAS NO INSULATION ISSUE. THE ICD AND RV LEAD WERE 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 24345527 ↗
• MalfunctionFeb 11, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS).  THE RV LEAD REMAINS IN USE.  NO PATIENT C OMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24315129 ↗
• InjuryFeb 10, 2026High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE AND 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 24306677 ↗
• MalfunctionFeb 2, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED CHRONIC HIGH RV THRESHOLD AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD. 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 24234445 ↗
• MalfunctionJan 27, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) POST VENTRICULAR SENSING ON RECORDED 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 24189984 ↗
• InjuryJan 15, 2026Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD FRACTURED. 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 24083002 ↗
• MalfunctionDec 15, 2025Pacing Problem; Under-Sensing; Pacing Problem; Under-Sensing

  IT WAS FURTHER REPORTED THAT THE PHYSICIAN STATED THAT THE RV LEAD PROBABLY WAS NOT UNDERSENSING BUT WAS SHOWING REFRACTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23802166 ↗
• InjuryDec 9, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE DEFIBRILLATION 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 23759323 ↗
• InjuryNov 25, 2025High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED AND PARTIALLY EXPLANTED DUE TO HIGH IMPEDANCE AND HIGH THRESHOLDS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23648846 ↗