Sprint Quattro Secure MRI™ SureScan™ 6947M55 (UDI 00643169356610)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,272 adverse event reports that list this exact device (DI 00643169356610), received between Dec 9, 2016 and Sep 30, 2026 — classified as 19 deaths, 739 injuries, 514 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (422 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 25 most recent of 1,272 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50954550 ↗
• InjurySep 30, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952425 ↗
• MalfunctionSep 28, 2026Over-Sensing

  It was reported that the caller inquired whether an adapter was available to convert the Right Ventricular (RV) lead from one connector type to another. The lead type was reviewed, and it was confirmed that no such adapter is available. Additional review indicated a lead integrity warning with findings suggestive of an RV tip conductor issue and intermittent high impedance. It was further reported that that the RV lead triggered a Lead Integrity Alert (LIA) 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 50917339 ↗
• InjurySep 18, 2026Signal Artifact/Noise; Fracture; Over-Sensing; Pacing Problem

  Patient problems: Syncope/Fainting

  MAUDE report 50828462 ↗
• MalfunctionSep 10, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50719851 ↗
• MalfunctionSep 3, 2026Low impedance; Adverse Event Without Identified Device or Use Problem

  It was reported that the Left Ventricular (LV) lead exhibited low 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 50590426 ↗
• MalfunctionAug 28, 2026Over-Sensing; Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50503256 ↗
• MalfunctionAug 26, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50464465 ↗
• InjuryAug 20, 2026Signal Artifact/Noise; Over-Sensing; Pacing Problem

  It was reported that the Right Ventricular (RV) lead triggered a Lead Integrity Alert (LIA) due to High Rate Non-Sustained episodes and an elevated Sensing Integrity Counter (SIC) count. The RV lead also exhibited noise as well as oversensing resulting in inhibition of pacing and misclassification of episode type. Undersensing on the Right Atrial (RA) lead was also noted. The RV lead was capped and replaced. The RA 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 50341021 ↗
• MalfunctionAug 17, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that the Right Ventricular (RV) lead triggered a lead noise warning and also exhibited T-Wave Oversensing (TWOS) on stored episodes, resulting in misclassification of arrhythmia episode type. 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 50277552 ↗
• MalfunctionAug 14, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50259052 ↗
• MalfunctionAug 14, 2026Over-Sensing; Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50254258 ↗
• MalfunctionAug 14, 2026Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50250521 ↗
• MalfunctionAug 10, 2026Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited undersensing resulting in termination of detected events in progress. In addition, the Implantable Cardioverter Defibrillator (ICD) detected an episode detected in the Ventricular Fibrillation (VF) zone that was suspected to be Supra Ventricular Tachycardia (SVT). 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 50198396 ↗
• InjuryAug 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by the patient that they experienced ongoing concerns related to Cardiac Resynchronization Therapy Defibrillator (CRT-D) follow-up and cardiac evaluation. The patient reported shortness of breath, dizziness, left-sided pain, leg edema, and difficulty walking, and stated that they had been told they had an obstruction and needed additional workup, including blood testing and an echocardiogram with contrast. The patient also reported that their CareLink monitor was not online and that there were delays and difficulties with follow-up care and referral coordination. The patient expressed frustration that the recommended evaluation and testing had not yet been completed. The CRT-D system remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Ambulation or Postural Difficulties; Dizziness; Dyspnea; Obstruction/Occlusion; Pain; Peripheral Edema

  MAUDE report 50195184 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) and Right Atrial (RA) lead were explanted and the Right Ventricular (RV) lead was capped due to an infection and erosion. No further patient complications have been reported as a result of this event.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 50130098 ↗
• InjuryAug 3, 2026Fracture; Over-Sensing; Impedance Problem

  It was reported that the Right Ventricular (RV) lead exhibited oversensing. A lead fracture was suspected. It was also reported that the Right Atrial (RA) lead exhibited noise. The RV lead and RA lead were 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 50116255 ↗
• MalfunctionJul 30, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS) post Ventricular Sense. 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 50086537 ↗
• MalfunctionJul 7, 2026Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INCREASE IN PACING IMPEDANCE, A DECREASE IN IMPEDANCE ON BOTH DEFI BRILLATION COILS, AND HIGH CAPTURE THRESHOLDS. THE LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FROM THE SINGLE CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR POSSIBLE SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE DEVICE DETECTED AS VENTRICULAR FIBRILLATION (VF), WITH THE FIRST SHOCK INDUCING A TRUE VENTRICULAR ARRHYTHMIA. THE ICD REMAINS 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 25736446 ↗
• InjuryJul 6, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). THE LEAD WAS REPROGRAMMED 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 25715235 ↗
• MalfunctionJun 26, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED T-WAVE OVERSENSING (TWOS). THERE WAS NO OBSERVED IMPACT TO OVERALL DEVICE FUNCTION OR PERFORMANCE. 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 25640566 ↗
• MalfunctionJun 26, 2026Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED PACING IMPEDANCE WARNINGS. IT WAS FURTHER REPORTED THAT THE RV IMPEDANCE MEASUREMENTS WERE CONSISTENT WITH HISTORICAL DATA. 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 25638886 ↗
• MalfunctionJun 19, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO SENSING INTEGRITY COUNTER (SIC) AND HIGH-RATE NON-SUSTAINED EPISODES. ADDITIONALLY, IT WAS NOTED THAT THE RV LEAD EXHIBITED OVERSENSING RESULTING IN MISCLASSIFICATION OF EPISODE TYPE. 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 25563547 ↗
• MalfunctionJun 16, 2026Over-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD DISPLAYED UNDERSENSING RESULTING IN MISCLASSIFICATION OF EPISODE DETECTION. SUBSEQUENTLY, THE PATIENT RECEIVED SHOCKS AND ANTI-TACHYCARDIA PACING (ATP) FOR AN EPISODE DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) ZONE THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). A SHOCK POSSIBLY ACCELERATED THE ARRYTHMIA INTO A VENTRICULAR ARRYTHMIA. ADDITIONALLY, THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED OVERSENSING. THE RA 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 25527237 ↗
• MalfunctionJun 12, 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 25487808 ↗