Sprint Quattro Secure S MRI™ SureScan™ 693565 (UDI 00763000180058)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000180058), received between Oct 28, 2025 and Sep 1, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 1, 2026Over-Sensing

  Patient problems: Dizziness

  MAUDE report 50550622 ↗
• InjuryMay 22, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM CONSISTING OF S AID DEVICE, A RIGHT VENTRICULAR (RV) LEAD WHOSE DEFIBRILLATION PORTION WAS CONNECTED BUT WHOSE PACE/SENSE PORTION WAS NOT UTILIZED , A LEAD IN THE LEFT BUNDLE BRANCH (LBB) THAT WAS CONNECTED FOR RV PACE/SENSE CAPACITY, AND A LEFT VENTRICULAR (LV) LEAD. AFTER THE CRT-D WAS PLACED IN THE POCKET, NOISE WAS BEING SENSED. THE POCKET WAS RE-OPENED AND THE LEADS WERE DISCONNECTED AND RECONNECTED BUT THE NOISE CONTINUED. THE CRT-D WAS REPLACED. THE NOISE CONTINUED ON THE NEW CRT-D. THE PHYSICIAN OPTED TO PUT THE LBB LEAD PREVIOUSLY BEING USED FOR RV PACE/SENSE CAPACITY INTO THE CRT-D'S ATRIAL PORT. THE SYSTEM 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 25260112 ↗
• MalfunctionMay 4, 2026Failure to Capture; Decreased Sensitivity; High Capture Threshold

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE SHOCKS AND ANTI-TACHYCARDIA PACING (ATP) FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE (RVR). THE ICD DETECTED THE EPISODES AS VENTRICULAR FIBRILLATION (VF). IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD SENSING AMPLITUDE HAS FALLEN SINCE IMPLANT. THE RV LEAD EXHIBITED HIGH THRESHOLDS AND SUSPECTED LOSS OF CAPTURE. 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 25075237 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST IMPLANT, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO AN INFECTION AND THE ORGANISM WAS REPORTED AS STAPHYLOCOCCUS AUREUS. ADDITIONALLY, THE PATIENT EXPERIENCED PURULENT DISCHARGE/PUS AND SWELLING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 25044930 ↗
• MalfunctionApr 17, 2026Over-Sensing

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

  Patient problems: Bradycardia

  MAUDE report 24912941 ↗
• MalfunctionApr 16, 2026Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A POSSIBLE LOSS OF CAPTURE ONE DAY POST-IMPLANT. 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 24905499 ↗
• MalfunctionFeb 17, 2026High impedance; Connection Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN TRIED TO ENGAGE THE RIGHT VENTRICULAR (RV) LEAD INTO THE IS1 PORT.  AFTER SEVERAL REMOVAL AND REENGAGEMENTS, THE SET SCREW SEEMED TO HAVE DISLODGED FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE HEADER AND HAD COMPLETELY COME OUT OF THE DEVICE HEADER.   ADDITIONALLY, IT WAS NOTED THAT THE CRT-D SETSCREW COULD NOT TURN, LOOSE SETSCREW, THE SETSCREW DISENGAGED FROM THREADS, DAMAGED/STRIPPED AND A SETSCREW/WRENCH INTERFACE PROBLEM OCCURRED.  IT WAS ALSO REPORTED THAT THE RV LEAD, DEFIBRILLATOR COIL IMPEDANCE WAS CONSTANTLY HIGH BUT UPON INITIAL LEAD CONNECTION THE DEFIBRILLATOR COIL IMPEDANCE WAS WITHIN NORMAL RANGE.  THE CRT-D WAS REPLACED.  THE RV LEAD WAS CONNECTED TO A NEW DEVICE AND 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 24369718 ↗
• MalfunctionJan 29, 2026Failure to Capture

  IT WAS REPORTED THAT ON THE SAME DAY OF IMPLANT, THERE WAS POSSIBLE NO CAPTURE FOR THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD. 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 24218709 ↗
• MalfunctionDec 4, 2025Signal Artifact/Noise; Failure to Capture; High impedance; Signal Artifact/Noise; Failure to Capture; High impedance

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A PACE/SENSE CONNECTION ISSUE. AFTER MULTIPLE ATTEMPTS A SIGNAL WAS UNABLE TO BE OBTAINED WITHOUT NOISE. UNDEFINED OUT OF RANGE (OOR) HIGH PACING IMPEDANCE AND NO CAPTURE WAS ALSO NOTED. A NEW RV LEAD WAS USED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23719798 ↗
• MalfunctionOct 28, 2025Signal Artifact/Noise; Fracture; High impedance; Signal Artifact/Noise; Fracture; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS ATTEMPTED, NOT IMPLANTED. THE PACING IMPEDANCE WAS HIGH, OUT OF RANGE WITH NOISE WHEN CONNECTED TIP TO RING OR TIP UNIPOLAR, BUT NORMAL MEASUREMENTS IN RING UNIPOLAR. A NEW ANALYZER CABLE WAS USED WITH THE SAME RESULTS. THE PHYSICIAN SUSPECTED THAT THERE WAS A TIP CONDUCTOR FRACTURE NEAR THE HELIX. A DIFFERENT LEAD WAS IMPLANTED AND 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 23405146 ↗