Sprint Quattro Secure S® 6935M72 (UDI 00643169550919)Recalls & reported problems

Summary

The FDA's MAUDE database contains 120 adverse event reports that list this exact device (DI 00643169550919), received between Apr 6, 2017 and Aug 28, 2026 — classified as 1 death, 66 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (39 reports).

1 FDA recall record name this device's identifier.

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.

Recalls naming this device

1. Nov 8, 2021Class IITerminated

   The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."

   Z-0390-2022 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 120 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50506672 ↗
• InjuryJun 26, 2026Failure to Capture; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE AND WAS OVERSENSING RESULTING IN POTENTIAL INAPPROPRIATE THERAPY. THE 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 25641355 ↗
• MalfunctionJun 26, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. ADDITIONALLY, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING AND POSSIBLE NOISE. 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 25638231 ↗
• InjuryJun 5, 2026Capturing Problem

  IT WAS REPORTED THAT POST-OPERATIVELY, THE PATIENT EXPERIENCED PARAVALVULAR TRICUSPID REGURGITATION IN THE REGION OF THE RIGHT VENTRICULAR (RV) LEAD IMPLANTED IN THE SEPTUM AND THE RV LEAD IMPLANTED IN THE APEX. ADDITIONALLY, LOW THRESHOLDS WERE NOTED ON THE RIGHT ATRIAL (RA) LEAD AND RV LEAD IMPLANTED IN THE APEX. TEMPORARY VENTRICULAR PACING WIRES WERE PLACED. ALL THE LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 25417408 ↗
• MalfunctionJun 1, 2026Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR TWO OR MORE HIGH RATE-NON SUSTAINED EPISODES, SENSING INTEGRITY COUNTER (SIC) AND A WARNING TRIGGERED FOR PACING IMPEDANCE. IT WAS ALSO REPORTED THAT THE RV LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) POST VENTRICULAR CONTRACTION WITH SMALL R WAVE LEADING TO VENTRICULAR SENSE/VS - FAST SENSE/FS CONTRIBUTING TO SHORT V-V COUNT. 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 25351218 ↗
• MalfunctionMay 29, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD UNDERSENSED A BEAT PRIOR TO VENTRICULAR TACHYCARDIA (VT) DETECTION. 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 25331035 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25318400 ↗
• MalfunctionMay 26, 2026Over-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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25285506 ↗
• InjuryMay 1, 2026Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD TRIGGERED ALERTS FOR OUT OF RANGE (OOR) DEFIBRILLATION IMPEDANCE AND WAS SUSPECTED TO HAVE HIGH VOLTAGE COIL FRACTURE. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED OUT OF RANGE (OOR) HIGH PACING IMPEDANCE. REPROGRAMMING WAS PERFORMED FOR THE RV LEAD. THE LEADS 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 25062310 ↗
• MalfunctionApr 3, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN UNDERSENSED VENTRICULAR BEAT. 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 24774562 ↗
• InjuryMar 16, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24607029 ↗
• MalfunctionMar 6, 2026Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD EXHIBITED NON-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 24536064 ↗
• MalfunctionFeb 16, 2026Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HISTORICAL RISE IN PACING IMPEDANCE MEASUREMENTS OVER TIME. THE IMPEDANCE AT THE TIME OF THE CALL WAS WITHIN THE EXPECTED RANGE. 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 24346520 ↗
• MalfunctionFeb 6, 2026Unstable Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT ABOVE RANGE 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 24283417 ↗
• MalfunctionJan 29, 2026Capturing Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO RECEIVING MULTIPLE SHOCKS FOR EPISODES DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE THAT WAS SUSPECTED TO BE GROUPINGS OF NON-SUSTAINED VENTRICULAR TACHYCARDIA (VT). IT WAS FURTHER REPORTED THAT THE CRT-D WAS REPROGRAMMED. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SLIGHT INCREASE IN THRESHOLDS. THE CRT-D 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 24210800 ↗
• MalfunctionJan 21, 2026Under-Sensing; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS. THE LEAD ALSO EXHIBITED UNDERSENSING THOUGH IT DID NOT APPEAR TO IMPACT OVERALL DEVICE FUNCTION. 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 24128842 ↗
• InjuryDec 15, 2025Over-Sensing; Over-Sensing

  IT WAS FURTHER REPORTED THAT THE RV LEAD WAS REVISED AND REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23811558 ↗
• MalfunctionDec 4, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED INTERMITTENT OVERSENSING. THE RV LEAD REMAINS IN USE. NO PATIENT COMP LICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23716472 ↗
• MalfunctionNov 10, 2025Signal Artifact/Noise; High impedance; Over-Sensing; Signal Artifact/Noise; High impedance; Over-Sensing

  IT WAS REPORTED THAT AN ALERT TRIGGERED FOR PACING IMPEDANCE ABOVE THE PROGRAMMED ALERT THRESHOLD ON THE RIGHT VENTRICULAR (RV) LEAD. T-WAVE OVERSENSING (TWOS) AND POSSIBLE NOISE WERE ALSO NOTED. 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 23511443 ↗
• MalfunctionOct 27, 2025Signal Artifact/Noise; Over-Sensing; Low impedance; Decreased Sensitivity; Impedance Problem; Signal Artifact/Noise; Over-Sensing; Low impedance; Decreased Sensitivity; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A DROP IN R-WAVES AND BEGAN TO EXHIBIT LOW PACING IMPEDANCE AT RANDOM POST-LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANT. NOISE WAS OBSERVED ON A PRESENTING ELECTROGRAM AND A LEAD INTEGRITY ALERT (LIA) HAD TRIGGERED DUE TO SHORT VENTRICULAR INTERVALS AND PACING IMPEDANCE VARIATION. THESE OBSERVATIONS PLUS LARGE LVAD MOTOR NOISE ON ELECTROGRAMS (EGM) WERE POTENTIALLY DUE TO ELECTROMAGNETIC INTERFERENCE WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE RV LEAD AND ICD 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 23391935 ↗
• MalfunctionOct 24, 2025High impedance; Over-Sensing; High impedance; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS) ON ALL STORED ELECTROGRAMS (EGM). ADDITIONALLY, THE RV LEAD TRIGGERED AN ALERT FOR HIGH RV DEFIBRILLATION IMPEDANCE AND LEAD TRENDS HAVE SHOWN CHRONIC HIGH 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 23380072 ↗
• MalfunctionAug 29, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A SENSING INTEGRITY COUNTER (SIC) THAT SHOWED A HIGH SHORT V-V INTERVALS. POTENTIAL OVERSENSING NOTED ON ELECTROGRAMS (EGM). IT WAS NOTED THAT THE LEAD APPEARS TO BE OVERSENSING OF PATIENT PHYSIOLOGY ON HIGH-RATE NON-SUSTAINED 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 22924141 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION AND WOUND DEHISCENCE. THE ENTIRE CARDIAC RESYNCHRONIZATION THERAPY D EFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Erosion; Medical device site infection; Wound Dehiscence

  MAUDE report 22792945 ↗
• MalfunctionJul 11, 2025Low impedance; Low impedance

  IT WAS REPORTED THAT A LEAD WARNING TRIGGERED DUE TO CHRONICALLY LOW PACING IMPEDANCE ON THE RIGHT VENTRICULAR (RV) LEAD. 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 22482083 ↗
• MalfunctionJun 24, 2025Under-Sensing; Under-Sensing

  IT WAS REPORTED THAT THERE WAS INTERMITTENT VENTRICULAR UNDERSENSING OBSERVED ON TREATED EPISODES OF VENTRICULAR FIBRILLATION (VF), THAT DID NOT APPEAR TO AFFECT THERAPY. THE RIGHT VENTRICULAR (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 22320709 ↗