SPRINT QUATTRO® 6944-65 (UDI 00643169451469)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169451469), received between Dec 9, 2016 and Mar 30, 2026 — classified as 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. 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 24736763 ↗
• InjuryMar 9, 2026Fracture; High impedance; Over-Sensing; Impedance Problem; Unstable Impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A SUSPECTED COIL FRACTURE. IT WAS FURTHER REPORTED THAT THE LEAD TRIGGERED AN ALERT FOR HIGH OUT OF RANGE (OOR) PACING IMPEDANCE, HIGH OUT OF RANGE (OOR) DEFIBRILLATION IMPEDANCE, UNDEFINED HIGH OUT OF RANGE (OOR) SUPERIOR VENA CAVA (SVC) COIL DEFIBRILLATION IMPEDANCE, AS WELL AS EXHIBITING VARYING RV DEFIBRILLATION IMPEDANCE, VARYING SVC DEFIBRILLATION IMPEDANCE, AND VARYING PACING IMPEDANCE. RIGHT VENTRICULAR (RV) LEAD DEFIBRILLATION IMPEDANCE ALSO EXHIBITED A RISING TREND. IT WAS FURTHER REPORTED THAT THERE WAS OVERSENSING PRESENT ON THE CURRENT ELECTROGRAMS (EGM). 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 24545638 ↗
• MalfunctionNov 7, 2025Failure to Capture; Pacing Problem; Under-Sensing; Device Sensing Problem; High Capture Threshold; Failure to Capture; Pacing Problem; Under-Sensing; Device Sensing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT WAS CHECKED AT THE HOSPITAL DUE TO SUSPECTED LOSS OF CAPTURE, INAPPROPRIATE PACING, AND DELIVERED HIGH VOLTAGE THERAPY. THE RIGHT VENTRICULAR (RV) LEAD CAPTURE WAS UNABLE TO BE CONFIRMED. THE RV LEAD EXHIBITED INTERMITTENT UNDERSENSING PRIOR TO VENTRICULAR FIBRILLATION (VF) DETECTION 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 23501553 ↗
• InjuryAug 15, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  SUBSEQUENTLY, THE RV LEAD WAS EXPLANTED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17550512 ↗
• InjuryJun 30, 2023Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH/UNDEFINED PACING IMPEDANCE DUE TO A SUSPECTED RV RING CONDUCTOR FRACTURE. IN ADDITION, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A PARTIAL POWER ON RESET (POR) BECAUSE OF A DROP IN THE BATTERY VOLTAGE. THE DEVICE AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS FITTED WITH A LIFEVEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238163 ↗
• InjuryOct 28, 2021High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD HIGH THRESHOLDS. 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 12712486 ↗
• InjuryMar 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO AN INFECTION APPROXIMATELY ONE MONTH POST-IMPLANT. ANTIBIOTIC TREATMENT WAS ADMINISTERED, CULTURES WERE TAKEN, AND THE ORGANISM WAS IDENTIFIED AS GRAM NEGATIVE BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 11560953 ↗
• InjuryMar 10, 2020High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SUDDEN SPIKE IN SUPERIOR VENA CAVA (SVC) COIL IMPEDANCES TO HIGH LEVELS. THE LEAD WAS EXPLANTED AND REPLACED AS PART OF A SYSTEM DOWNGRADE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9813977 ↗
• MalfunctionFeb 19, 2019Intermittent Capture; Failure to Capture; Intermittent Capture; Failure to Capture

  IT WAS REPORTED THAT THERE WAS POSSIBLE INTERMITTENT BIVENTRICULAR CAPTURE AND THE INTERMITTENT BIVENTRICULAR PACING APPEARED NOT TO CAPTURE. IT WAS FURTHER REPORTED THE PATIENT WAS VOMITING. THE LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Vomiting

  MAUDE report 8349710 ↗
• InjuryFeb 18, 2019Over-Sensing; Decreased Sensitivity; Impedance Problem; High Capture Threshold; Over-Sensing; Decreased Sensitivity; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXHIBITED SUDDEN HIGH PACING THRESHOLDS, SLOWLY DECREASING R-WAVES, SLOWLY INCREASING PACING IMPEDANCE AND SHORT EPISODES OF OCCASIONAL OVERSENSING. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND REPLACED WHILE THE DEFIBRILLATION PORTION 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 8347617 ↗
• MalfunctionApr 10, 2018Over-Sensing; High Capture Threshold; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAS BEEN EXHIBITING HIGH THRESHOLDS. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLD A COUPLE OF MONTHS AGO AND PRIOR TO THAT. THE RA LEAD AND RV LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7417100 ↗
• InjuryJun 8, 2017Over-Sensing; Device Dislodged or Dislocated; Over-Sensing; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGERED AND THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WITH CHEST PAIN DUE TO INAPPROPRIATE SHOCKS BY THE RIGHT VENTRICULAR (RV) LEAD. THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED AND WAS FOUND TO HAVE OVERSENSING WITH HIGH RATE NON-SUSTAINED (HR-NS) AND SENSING INTEGRITY COUNTER (SIC) EPISODES. THE LEAD WAS ATTEMPTED TO BE REPOSITIONED BUT WOULD NOT STAY IN PLACE. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD DISLODGED. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Shock from Patient Lead(s)

  MAUDE report 6627713 ↗
• InjuryDec 9, 2016Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT HAD THERAPIES WITHHELD DUE TO T-WAVE OVERSENSING BY THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS R PROGRAMMED WITH NO FURTHER T-WAVE OVERSENSING OBSERVED IN THE CLINIC. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Tachycardia

  MAUDE report 6163380 ↗