Sprint Quattro Secure® 694765Recalls & reported problems

Summary

The FDA's MAUDE database contains 3,852 adverse event reports that list this exact device (DI 00613994249890), received between Feb 11, 2013 and Sep 30, 2026 — classified as 73 deaths, 2,457 injuries, 1,322 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (1,405 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 3,852 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026High impedance

  It was reported that the Right Ventricular (RV) lead exhibited undefined high Superior Vena Cava (SVC) defibrillation 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 50948908 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort; Erosion; Medical device site infection

  MAUDE report 50940015 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to an infection resulting in discomfort, erosion, redness, swelling and wound dehiscence. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Erosion; Erythema; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 50934464 ↗
• InjurySep 29, 2026Fracture; High impedance; Over-Sensing; Unstable Impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50926873 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) patient experienced an infection. The device system was explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50897497 ↗
• InjurySep 24, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the Implantable Cardioverter Defibrillator (ICD) system was was explanted and replaced for 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 50888544 ↗
• InjurySep 24, 2026Fracture; High impedance

  It was reported that the Right Ventricular (RV) lead had a suspected fracture. The lead exhibited high impedance. The lead was capped and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885303 ↗
• MalfunctionSep 24, 2026Failure to Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883380 ↗
• MalfunctionSep 18, 2026Under-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited undersensing during detected arrhythmia episodes and suspected during detected ventricular sensing episodes. It was also reported that the Right Atrial (RA) lead exhibited undersensing. 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 50821109 ↗
• InjurySep 18, 2026Signal Artifact/Noise; Fracture; High impedance; Over-Sensing; Pacing Problem; High Capture Threshold; Unstable Impedance

  It was reported that the patient presented with chest pain, and upon review it was found that the Right Ventricular (RV) lead triggered a Lead Integrity Alert (LIA) due to increase in Sensing Integrity Counter (SIC) and two or more High Rate-Non Sustained episodes. An RV lead fracture was suspected. The lead exhibited high undefined Superior Vena Cava (SVC) coil impedance, varying pacing impedance, oversensing resulting in inhibition of pacing, noise, and high capture thresholds. All high voltage therapies were programmed off. It was also reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) stored episodes resulting in termination of AT/AF detected event(s) in progress, with inappropriate atrial pacing note at times. The leads remain in use. No further patient complications have been reported as a result of this event.

  Patient problems: Chest Pain

  MAUDE report 50819509 ↗
• InjurySep 17, 2026Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS) post ventricular sense. Reprogramming was done to adjust the sensitivity and 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 50806764 ↗
• MalfunctionSep 16, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited noise and 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 50793298 ↗
• InjurySep 15, 2026High impedance

  It was reported that the Right Ventricular (RV) lead exhibited high undefined defibrillation and SVC coil impedances. 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 50775014 ↗
• MalfunctionSep 14, 2026Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755375 ↗
• InjurySep 8, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the patient had a significant allergic reaction after the last generator change and multiple additional surgeries unrelated to the implanted system. They patient underwent testing over the years which determined they were not allergic to titanium, and it was felt that the patient was allergic to the insulation materials of the Right Ventricular (RV) and Right Atrial (RA) leads. The patient takes biologic material and prescription oral corticosteroid, and the patients dermatologist prescribed a regimen of antihistamine. Both leads remain in use. No further patient complications have been reported as a result of this event

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 50670833 ↗
• MalfunctionSep 4, 2026Signal Artifact/Noise; High impedance; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50613962 ↗
• MalfunctionSep 4, 2026Over-Sensing; Unstable Impedance

  It was further reported that the lead was reprogrammed and remains in use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50613348 ↗
• MalfunctionSep 3, 2026High Capture Threshold

  It was reported that the Right Ventricular (RV) lead exhibited chronically high thresholds. The 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 50589084 ↗
• MalfunctionSep 2, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568414 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) and Right Ventricular (RV) lead were explanted. The reason for explant was not reported. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50533383 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed a pocket infection approximately one month post-Cardiac Resynchronization Therapy Defibri llator (CRT-D) implant. The patient had also experienced purulent discharge/pus, redness and swelling. The organism was identified as Staphylococcus aureus. The CRT-D system was removed and a leadless pacemaker was implanted. No further patient complications have been reported as a result of this event.

  Patient problems: Bacterial Infection; Erythema; Medical device site infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 50530717 ↗
• InjuryAug 31, 2026Signal Artifact/Noise; Over-Sensing

  It was reported that the Right Ventricular (RV) lead exhibited noise/oversensing and elevated Sensing Integrity Counter (SIC). The R ight Ventricular (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 50524470 ↗
• MalfunctionAug 27, 2026Low impedance

  It was reported that the Right Ventricular (RV) lead exhibited multiple alerts for low Out of Range (OOR) impedance throughout three years. 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 50486013 ↗
• InjuryAug 27, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) was explanted and replaced for an unknown reason. It was also noted that the Right Ventricular (RV) lead was capped and replaced for and unknown reason. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50482659 ↗
• InjuryAug 27, 2026Signal Artifact/Noise

  It was reported that noise was observed on the Right Ventricular (RV) lead. Reprogramming was done. Subsequently, the RV lead was capped and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50472910 ↗