Sprint Quattro Secure® 6947M55 (UDI 00643169082243)Recalls & reported problems

Summary

The FDA's MAUDE database contains 603 adverse event reports that list this exact device (DI 00643169082243), received between Aug 10, 2013 and Sep 29, 2026 — classified as 8 deaths, 367 injuries, 228 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (220 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 603 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940642 ↗
• MalfunctionSep 14, 2026Failure to Capture; Capturing Problem; High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited increasing and high capture thresholds, and capture could not be conf irmed. 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 50755077 ↗
• InjurySep 9, 2026Under-Sensing

  It was reported by a Health Care Professional (HCP) that the patient had been in sustained Ventricular Tachycardia (VT) and the device eventually shocked the patient, but the HCP was suspicious that the device was not working as it should. A review of the device data by qualified personnel determined that stored episode revealed ventricular undersensing resulting in delayed detection and therapy at times. The Right Ventricular (RV) lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Tachycardia

  MAUDE report 50691567 ↗
• MalfunctionSep 8, 2026Capturing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50675986 ↗
• MalfunctionAug 28, 2026Fracture; Connection Problem

  It was reported that the Right Ventricular (RV) lead exhibited an apparent fracture. It was also reported that the Cardiac Resynchro nization Therapy Defibrillator (CRT-D) setscrew was noted to be sideways in the port, observed to be misaligned. In addition, there was High RV Pacing Impedance that was noted. However, further investigation noted that the RV lead performance was okay as it turned out that the CRT-D set screw was misaligned. The CRT-D was explanted and replaced, and the RV lead remains implanted active. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50500879 ↗
• InjuryAug 24, 2026High impedance

  It was reported that the Right Ventricular (RV) lead exhibited high Superior Vena Cava (SVC) defibrillation impedance. This was a known issue and the SVC coil was programmed off. 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 50417636 ↗
• MalfunctionAug 12, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50224315 ↗
• MalfunctionAug 7, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50168800 ↗
• MalfunctionJul 8, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING ON STORED ELECTROGRAMS (EGM). 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 25751685 ↗
• InjuryJul 7, 2026Signal Artifact/Noise; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD NOISE WARNING AND EXHIBITED OVERSENSING OF NON-PHYSIOLOGICAL INTERVALS. THE RV LEAD OVERSENSING RESULTED IN MISCLASSIFICATION OF EPISODE TYPE. THE PATIENT RECEIVED SUSPECTED INAPPROPRIATE HIGH VOLTAGE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25737640 ↗
• MalfunctionJul 6, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH RV 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 25718680 ↗
• MalfunctionJun 19, 2026Low impedance; Impedance Problem

  IT WAS REPORTED THAT DURING USE OF THE RIGHT VENTRICULAR (RV) LEAD, A MESSAGE FROM THE MAGNETIC RESONANCE IMAGING (MRI) ACCESS APP WAS RECEIVED THAT INDICATED "LEAD IMPEDANCE EXCEEDS LIMITS". 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 25563400 ↗
• MalfunctionJun 11, 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 25473689 ↗
• MalfunctionMay 29, 2026Fracture; High impedance; Unstable Impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SUDDEN FLUCTUATION OF HIGH IMPEDANCE ON THE SUPERIOR VENA CAVA (SVC) COIL. ADDITIONALLY, IT WAS NOTED THAT THERE WAS FLUCTUATING PACING IMPEDANCE. 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 25335469 ↗
• InjuryMay 27, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE LEAD FAILED. THE LEAD COULD NOT BE TAKEN OUT SO IT WAS TURNED OFF AND REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25303057 ↗
• MalfunctionMay 22, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE. 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 25259881 ↗
• MalfunctionMay 5, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). IT WAS NOTED THAT THE TWOS DID NOT IMPACT DEVICE FUNCTION OR PERFORMANCE. 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 25085071 ↗
• MalfunctionApr 21, 2026High impedance

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED LEAD IMPEDANCE WARNING FOR UNDEFINED HIGH RV DEFIBRILLATION IMPEDANCE, UN DEFINED HIGH SUPERIOR VENA CAVA (SVC) DEFIBRILLATION IMPEDANCE, AND UNDEFINED HIGH RV TIP TO RV COIL PACING IMPEDANCE. THE LEFT VENTRICULAR (LV) LEAD ALSO EXHIBITED LOSS OF CAPTURE. 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 24945613 ↗
• InjuryApr 1, 2026Fracture; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR UNDEFINED HIGH PACING IMPEDANCE BETWEEN THE RV TIP TO RV COIL. IN ADDITION, THE SUPERIOR VENA CAVA (SVC) AND RIGHT VENTRICULAR (RV) COILS EXHIBITED UNDEFINED HIGH DEFIBRILLATION 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 24759480 ↗
• MalfunctionMar 30, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH RV 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 24721483 ↗
• MalfunctionMar 30, 2026High impedance; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN IMPEDANCE WARNING FOR HIGH OUT OF RANGE SUPERIOR VENA CAVA (SVC) DEFIBRILLATION IMPEDANCES. A "JUMP" IN SVC IMPEDANCE ABOVE BASELINE WAS NOTED. 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 24717239 ↗
• InjuryMar 23, 2026Appropriate Device Problem Term/Code Not Available

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664990 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 24562727 ↗
• MalfunctionMar 4, 2026Over-Sensing; Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVER AND UNDERSENSING, POSSIBLY DUE TO CARDIOPULMONARY RESUSCITATION. 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 24508562 ↗
• MalfunctionFeb 9, 2026High impedance; Impedance Problem; Unstable Impedance

  IT WAS REPORTED THAT SUPERIOR VENA CAVA (SVC) DEFIBRILLATION COIL IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD HAD INCREASED AND AN ALERT TRIGGERED WHEN IT REACHED A HIGH UNDEFINED RANGE. THE LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THAT RIGHT ATRIAL (RA) LEAD EXHIBITED VARIABLE IMPEDANCE AND THAT AN ALERT HAD TRIGGERED FOR HIGH UNDEFINED IMPEDANCE. THE LEAD ALSO EXHIBITED HIGH THRESHOLDS, ATRIAL CAPTURE COULD NOT BE CONFIRMED, AND NOISE WAS PRODUCED WITH ISOMETRICS. 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 24294132 ↗