Attain Stability™ Quad MRI SureScan™ 479878Recalls & reported problems

Summary

The FDA's MAUDE database contains 414 adverse event reports that list this exact device (DI 00643169860414), received between Jul 5, 2019 and Sep 25, 2026 — classified as 4 deaths, 258 injuries, 152 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (84 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 414 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacterial Infection; Fungal Infection; Medical device site infection

  MAUDE report 50903962 ↗
• MalfunctionSep 25, 2026High Capture Threshold

  It was reported that the Left Ventricular (LV) lead exhibited high thresholds.  The LV 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 50900365 ↗
• InjurySep 16, 2026High impedance; Impedance Problem

  It was reported that the Left Ventricular (LV) lead exhibited a gradual increase in impedance to a high undefined range. The lead was programmed to another vector though the observation recurred. 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 50785426 ↗
• MalfunctionSep 14, 2026Impedance Problem

  It was reported that one day post-implant, the Left Ventricular (LV) lead exhibited an increase in pacing 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 50756198 ↗
• MalfunctionSep 8, 2026Intermittent Capture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50673371 ↗
• MalfunctionAug 31, 2026Extracardiac stimulation; High Capture Threshold

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50519454 ↗
• InjuryAug 30, 2026Failure to Capture; Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50514809 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Pacemaker (CRT-P) system was explanted due to a pocket infection and redness. No further patient complications have been reported as a result of this event.

  Patient problems: Erythema; Unspecified Infection

  MAUDE report 50451933 ↗
• InjuryAug 21, 2026Extracardiac stimulation; Insufficient Device Problem Information; High Capture Threshold

  It was reported that the Left Ventricular (LV) lead was explanted and replaced for unknown reasons. No patient complications have been reported as a result of this event.

  Patient problems: Inappropriate Device Stimulation of Tissue; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50381836 ↗
• MalfunctionAug 21, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50379969 ↗
• InjuryAug 19, 2026Extracardiac stimulation

  It was reported that the patient experienced palpitations and thumping in her chest. Phrenic nerve stimulation was confirmed. The LV lead polarity was reprogrammed. The Phrenic nerve stimulation was resolved. The LV lead remains in use and will continue to be monitored. No further patient complications have been reported as a result of this event. The patient is a participant in a clinical study.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50331133 ↗
• MalfunctionAug 14, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255269 ↗
• InjuryAug 3, 2026Extracardiac stimulation; High Capture Threshold

  It was reported that the Left Ventricular (LV) lead exhibited slightly elevated capture thresholds since implant fifteen months prior. The patient experienced diaphragmatic stimulation in all lead vectors. The lead was explanted and replaced with a left bundle branch lead. No further patient complications have been reported as a result of this event.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 50120178 ↗
• InjuryJul 30, 2026Device Dislodged or Dislocated; High Capture Threshold

  It was reported that the Left Ventricular (LV) lead dislodged post-operatively, causing high 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 50085051 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted and replaced with a leadless Implantable Pulse Generator (IPG) due to a systemic infection with bacteremia and fever. The organism of the infection was identified as Methicillin-sensitive Staphylococcus aureus. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Bacterial Infection; Fever

  MAUDE report 50078420 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the lead was explanted and replaced due to infection. The patient also experienced pain, redness, swelling, and purulent discharge. No further patient complications have been reported as a result of this event.

  Patient problems: Erythema; Pain; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 50039603 ↗
• InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY FIVE AND A HALF WEEKS AFTER IMPLANT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. IT WAS NOTED THAT A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25719425 ↗
• InjuryJul 1, 2026High Capture Threshold

  IT WAS REPORTED BY THE PATIENT THAT THEY BELIEVE THE BATTERY "SHOULD LAST LONGER" ON THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD CONTRIBUTING TO THE BATTERY DEPLETION AND REPROGRAMMING WAS PERFORMED AND THE BATTERY DEPLETION CURRENTLY SEEMS TO BE CONSISTENT WITH CURRENT LV OUTPUT THRESHOLD. THE LV AND THE CRT-D 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 25679338 ↗
• InjuryJun 25, 2026Extracardiac stimulation

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED DIAPHRAGM SPASMS STATING, "THEY WERE HARD AND BAD." THE PATIENT NOTED THAT THEY WERE HOSPITALIZED AND ADJUSTMENTS WERE MADE. THE LEFT VENTRICULAR (LV) LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 25622666 ↗
• InjuryJun 23, 2026Extracardiac stimulation

  THE PATIENT REPORTED THAT "THIS THING IS HUGE COMPARED TO MY STJ DEVICE" AND ALSO STATED "THIS DEVICE WAS BEATING LIKE A DRUM". THE PATIENT IS NOT FEELING THE "BANG" AT HOME. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED POSTOPERATIVELY WHEN THE PATIENT WOKE UP THEY EXPERIENCED PHRENIC NERVE STIMULATION THAT FELT LIKE "HICCUPS", THEY WERE VISIBLE TO THE EYE, AND PHRENIC NERVE STIMULATION WAS ABLE TO BE FELT ON THEIR CHEST. IT WAS FURTHER REPORTED THAT THE PATIENT FELT LIKE THEIR HEART WAS BEATING FAST AND THEIR SIDE WAS SORE DUE TO THE CRTP. THE PATIENT EXPLAINED THAT THE "DEVICE WAS BEATING LIKE A DRUM" WAS DIFFERENT THAN THE PHRENIC NERVE STIMULATION. THE LEFT VENTRICULAR (LV) LEAD WAS REPROGRAMMED. THE PATIENT REPORTED NOT FEELING THE PHRENIC NERVE STIMULATION FOLLOWING REPROGRAMMING. THERE WAS NO PERFORMANCE ISSUE WITH THE CRTP. THE CRTP AND LV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue; Hiccups

  MAUDE report 25591989 ↗
• MalfunctionJun 18, 2026Intermittent Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED INTERMITTENT CAPTURE AND IT WAS NOTED THAT THE PATIENT REMARKED FEELING FATIGUED. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fatigue

  MAUDE report 25549030 ↗
• InjuryJun 12, 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 WITH VEGETATION. THE PATIENT HAD ALSO EXPERIENCED A FEVER, AND THE SOURCE OF THE INFECTION WAS AN ABSCESSED TOOTH. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 25488607 ↗
• InjuryJun 9, 2026Extracardiac stimulation

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING THAT RESULTED IN EPISODE MISCLASSIFICATION. THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. THE LV LEAD WAS REPROGRAMMED AND REMAINS IN USE. THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 25449259 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED DUE TO INFECTION. PURULENT DISCHARGE AND SWELLING WERE NOTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 25321681 ↗
• MalfunctionMay 27, 2026High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED CHRONIC HIGH THRESHOLDS. THE LV 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 25301458 ↗