Sprint Quattro® 6944-58 (UDI 00613994249951)Recalls & reported problems

Summary

The FDA's MAUDE database contains 233 adverse event reports that list this exact device (DI 00613994249951), received between Apr 6, 2017 and Sep 23, 2026 — classified as 6 deaths, 161 injuries, 66 malfunctions.

The most frequently reported specific device problem is “High impedance” (134 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 233 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Pacing Problem; Under-Sensing

  It was reported that high-voltage therapy was delivered in the Ventricular Fibrillation (VF) zone for a possible dual-arrhythmia that may have been Atrial Fibrillation (AF) with Fast Ventricular Rates. It was also noted that the Right Atrial (RA) lead exhibited under sensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) resulting in unnecessary pacing at times causing pre-termination in AT/AF in progress. Additionally, the Right Ventricular (RV) lead exhibited under sensing resulting in unnecessary ventricular pacing at times. The Implantable Cardioverter Defibrillator (ICD), Right Atrial (RA) lead and Right Ventricular (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 50871179 ↗
• MalfunctionSep 2, 2026Signal Artifact/Noise; High impedance; Over-Sensing; High Capture Threshold; Unstable Impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50570519 ↗
• MalfunctionJun 26, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING ON STORED EPISODES, RESULTING IN NON-PHYSIOLOGIC INTERVALS. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT DUE TO HIGH THRESHOLDS. THE MEASUREMENT WAS NOTED TO BE CONSISTENT WITH HISTORICAL MEASUREMENTS. 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 25636215 ↗
• MalfunctionMay 27, 2026Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND A GRADUAL RISE OVER TIME IN RV PACING IMPEDANCE M EASUREMENTS. 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 25302917 ↗
• MalfunctionApr 7, 2026High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR OUT OF RANGE HIGH PACING IMPEDANCE. THE RV PACING IMPEDANCE HAD BEEN SLOWLY RISING. 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 24802027 ↗
• MalfunctionJan 5, 2026Impedance Problem

  IT WAS REPORTED THAT THERE WAS A GRADUAL RISE IN RIGHT VENTRICULAR (RV) PACING IMPEDANCE OBSERVED THAT TRIGGERED A LEAD WARNING. 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 23959581 ↗
• InjuryJan 2, 2026Fracture; High impedance

  IT WAS FURTHER REPORTED THAT REPROGRAMMING WAS DONE WITH THE HIGH VOLTAGE THERAPIES TURNED OFF. PER PHYSICIAN'S MEDICAL JUDGEMENT, S URGICAL INTERVENTION FOR THE RV LEAD WAS NOT NEEDED DUE TO THE PATIENT'S IMPROVED EJECTION FRACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23946722 ↗
• InjuryDec 23, 2025Fracture; High impedance; Impedance Problem; Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED WARNINGS FOR HIGH RV DEFIBRILLATION, HIGH SUPERIOR VENA CAVA (SVC), AND HIGH RV PACING IMPEDANCES. AFTER FURTHER REVIEW, A RISE OVER TIME EVENTUALLY RESULTING IN A SUDDEN INCREASE OF THE RV DEFIBRILLATION AND SVC COIL IMPEDANCES WAS NOTED. IN ADDITION, A RIDE IN THE RV PACING IMPEDANCES OVER TIME WAS NOTED. A FRACTURE WAS SUSPECTED. 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 23879529 ↗
• InjuryDec 8, 2025Over-Sensing; Decreased Sensitivity; Over-Sensing; Decreased Sensitivity

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED CROSSTALK AND SMALL R-WAVES. AN ATTEMPT WAS MADE TO LOWER OUTPUT ON THE ATRIAL LEAD TO 1.0V (THRESHOLD IS 0.75V) TO OMIT CROSSTALK BUT IT WAS STILL PRESENT. IN ADDITION TO THE CROSSTALK, BIPOLAR SENSING WAS 0.8MV AND INTEGRATED BIPOLAR WAS 3.5MV ON THE RV LEAD CHRONICALLY. THE DECISION WAS MADE TO IMPLANT A NEW RV DEFIBRILLATION LEAD. DURING THE REVISION PROCEDURE; SEVERAL LOCATIONS WERE MAPPED IN THE VENTRICLE BUT GOT POOR R WAVES. R WAVES STARTED IN 7'S AND AFTER TYING DOWN THE LEAD HAD DIMINISHED TO 1.75-3.125MV. R WAVES WERE FELT TO BE INADEQUATE. THE DECISION WAS MADE TO NOT IMPLANT A NEW RV DEFIBRILLATION LEAD; RATHER ADD AN RV PACE/SENSE LEAD. THE RV PACE/SENSE LEAD WAS PLACED IN THE MID-HIGH SEPTUM (A LOCATION THAT WAS UNABLE TO BE USED WITH THE ATTEMPTED RV DEFIBRILLATION LEAD DUE TO LIMITED SPACE AND INTERACTION WITH THE CHRONIC RV LEAD)WITH GREAT SENSING. THE RV DEFIBRILLATION COIL IMPEDANCES WERE STABLE AND CONNECTED THE EXISTING RV DEFIBRILLATION COILS TO THE NEW IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WHILE USING THE RV PACE/SENSE LEAD AS WELL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23750695 ↗
• InjuryOct 29, 2025High impedance; Over-Sensing; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED EPISODES. THE LEAD EXHIBITED UNDEFINED OUT OF RANGE HIGH PACING IMPEDANCE AND OVERSENSING. 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 23414859 ↗
• InjuryApr 3, 2025Fracture; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21765136 ↗
• MalfunctionMar 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO THERAPY UPGRADE/DOWNGRADE AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21585246 ↗
• MalfunctionDec 9, 2024High impedance; Over-Sensing; Unstable Impedance; High impedance; Over-Sensing; Unstable Impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN OUT OF RANGE (OOR) HIGH BIPOLAR PACING IMPEDANCE ALERT THAT WAS CONSISTENT WITH HISTORICAL MEASUREMENTS. 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 20886336 ↗
• MalfunctionDec 9, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH UNDEFINED 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 20877335 ↗
• InjuryDec 4, 2024Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD DUE TO HIGH RATE NON-SUSTAINED (HRNS) EPISODES AND SENSING INTEGRITY COUNTER (SIC). A REVIEW OF THE DEVICE DATA ALSO SHOWED A FEW BEATS OF T-WAVE OVERSENSING (TWOS). THE HEALTH CARE PROFESSIONAL (HCP) PERFORMED ISOMETRICS AND POCKET MANIPULATION WITH NO ANOMALIES OBSERVED. THE PATIENT WILL BE MONITORED, AND 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; Shock from Patient Lead(s)

  MAUDE report 20846512 ↗
• MalfunctionNov 20, 2024High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH UNDEFINED PACING IMPEDANCE AND 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 20739845 ↗
• InjuryNov 20, 2024Signal Artifact/Noise; Fracture; High impedance; Inappropriate/Inadequate Shock/Stimulation; Signal Artifact/Noise; Fracture; High impedance; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A FRACTURE AND WAS EXHIBITING UNDEFINED HIGH PACING IMPEDANCE, NOISE, AND CAUSED THE PATIENT TO EXPERIENCE INAPPROPRIATE THERAPY. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20735835 ↗
• InjuryOct 30, 2024Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE RESULTING IN RV LEAD INTEGRITY ALERT (LIA) THAT WAS TRIGGERED 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 20570904 ↗
• DeathOct 25, 2024Over-Sensing; Over-Sensing

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

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20537685 ↗
• MalfunctionSep 25, 2024High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A BIPOLAR LEAD IMPEDANCE WARNING, RV TIP TO RV COIL LEAD PACING IMPEDANCES, AND HIGH RV 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 20301305 ↗
• InjuryJul 24, 2024Signal Artifact/Noise; Fracture; High impedance; Connection Problem; Impedance Problem; Signal Artifact/Noise; Fracture; High impedance; Connection Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE (OOR) DEFIBRILLATION IMPEDANCES OF THE RV COIL ALONG WITH IMPEDANCE SPIKES. 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 19820108 ↗
• InjuryJun 26, 2024Signal Artifact/Noise; High impedance; Impedance Problem; Signal Artifact/Noise; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR HIGH RV COIL DEFIBRILLATION IMPEDANCE AND HIGH SUPERIOR VENA CAVA (SVC) COIL DEFIBRILLATION IMPEDANCE. IT WAS ALSO REPORTED THAT THE DEFIBRILLATION IMPEDANCE MEASUREMENTS AS WELL AS THE SVC IMPEDANCE MEASUREMENTS WERE RISING AND THAT THE RV COIL IMPEDANCE MEASUREMENTS HAD "JUMPED". ADDITIONALLY, THE LEAD DISPLAYED NOISE ON ELECTROGRAMS (EGM). 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 19616062 ↗
• InjuryJun 11, 2024Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED T-WAVE OVERSENSING (TWOS). PROGRAMMING CHANGES WERE MADE AND 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 19515046 ↗
• MalfunctionMay 3, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT REPORTED PAIN AROUND THE SITE OF THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), HOWEVER, THE HEALTH CARE PROFESSIONAL (HCP) REPORTED NO ABNORMALITIES WERE FOUND AT THE DEVICE SITE. IT WAS FURTHER REPORTED THAT THERE WERE HIGH CAPTURE THRESHOLDS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD, WHICH WERE CONSISTENT WITH HISTORICAL VALUES. 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 19240124 ↗
• MalfunctionApr 19, 2024Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL DUE TO VERTIGO. IT WAS DETERMINED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vertigo

  MAUDE report 19142956 ↗