Sprint Quattro Secure SRecalls & reported problems across all models

We found 19 models of Sprint Quattro Secure S by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 5,299 adverse event reports in the FDA's MAUDE database, received between Aug 10, 2013 and Sep 30, 2026 — classified as 75 deaths, 3,359 injuries, 1,865 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (2,255 reports).

1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Sprint Quattro Secure S recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 8, 2021Terminated

   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 · names 3 of these models · Recall details · FDA record ↗

Most reported Sprint Quattro Secure S problems

Sprint Quattro Secure S models

19 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Sprint Quattro Secure S® 6935M62

  Permanent defibrillator electrodes
  33 deaths1,731 reports
• Sprint Quattro Secure S® 6935M55

  Permanent defibrillator electrodes
  13 deaths998 reports
• Sprint Quattro Secure S® 6935M62

  Permanent defibrillator electrodes
  11 deaths735 reports
• Sprint Quattro Secure S™ 693565

  Permanent defibrillator electrodes
  10 deaths657 reports
• Sprint Quattro Secure S™ 693558

  permanent pacemaker Electrode
  4 deaths515 reports
• Sprint Quattro Secure S® 6935M55

  Permanent defibrillator electrodes
  2 deaths449 reports
• Sprint Quattro Secure S® 6935M72

  Permanent defibrillator electrodes
  1 recall1 death120 reports
• Sprint Quattro Secure S® 6935M72

  Permanent defibrillator electrodes
  1 recall13 reports
• Sprint Quattro Secure S® 6935M72

  permanent pacemaker Electrode
  1 recall11 reports
• Sprint Quattro Secure S® 6947M72

  permanent pacemaker Electrode
  30 reports
• Sprint Quattro Secure S™ 693575

  permanent pacemaker Electrode
  11 reports
• Sprint Quattro Secure S® 6935M97

  Permanent defibrillator electrodes
  7 reports
• Sprint Quattro Secure S™ 693552

  permanent pacemaker Electrode
  4 reports
• Sprint Quattro Secure S® 6935M49

  Permanent defibrillator electrodes
  4 reports
• Sprint Quattro Secure S® 6935M49

  Permanent defibrillator electrodes
  4 reports
• Sprint Quattro Secure S® 6935M49

  Permanent defibrillator electrodes
  4 reports
• Sprint Quattro Secure S® 6947M62

  permanent pacemaker Electrode
  1 death3 reports
• Sprint Quattro Secure S® 6947M97

  permanent pacemaker Electrode
  2 reports
• Sprint Quattro Secure S™ 6935100

  permanent pacemaker Electrode
  1 report

Recent Sprint Quattro Secure S adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951539 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacteremia

  MAUDE report 50951342 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) system was removed due to systemic infection with vegetation noted on the Right Ventricular (RV) and Right Atrial (RA) leads. No further patient complications have been reported as a result of this event.

  Patient problems: Medical device site infection

  MAUDE report 50916086 ↗
• InjurySep 25, 2026Signal Artifact/Noise; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903852 ↗
• MalfunctionSep 25, 2026Unstable Capture Threshold

  It was reported that there were two Right Ventricular (RV) lead threshold measurements outside the expected range but still within the programmed output. 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 50897754 ↗
• MalfunctionSep 24, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889868 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort; Erythema; Medical device site infection; Pain; Purulent Discharge; Swelling/ Edema

  MAUDE report 50888810 ↗
• MalfunctionSep 24, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) lead triggered a Lead Integrity Alert (LIA) due to increased Sensing Integrity Counter (SIC) and two or more 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 50883105 ↗
• InjurySep 18, 2026High impedance; Difficult to Remove; Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831255 ↗
• InjurySep 18, 2026Fracture; High impedance; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829064 ↗
• InjurySep 15, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited non-physiologic oversensing. The RV lead was 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 50777295 ↗
• MalfunctionSep 14, 2026Signal Artifact/Noise; Fracture; High impedance

  It was reported that the Right Ventricular (RV) lead exhibited a jump in pacing and defibrillation impedances, and a warning was triggered for high impedances. It was also reported that non-physiologic noise was observed on the electrograms (EGM), and a RV coil fracture was suspected. 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 50759272 ↗
• InjurySep 14, 2026Capturing Problem; Impedance Problem; High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited rising defibrillation impedance and rising and high RV thresholds. The lead was 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 50752562 ↗
• MalfunctionSep 11, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50740599 ↗
• InjurySep 10, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted and replaced due to an infection with Endocarditis. No further patient complications have been reported as a result of this event.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 50716989 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls