Attain Ability® 419688Recalls & reported problems

Summary

The FDA's MAUDE database contains 761 adverse event reports that list this exact device (DI 00613994469731), received between Feb 25, 2013 and Sep 30, 2026 — classified as 9 deaths, 559 injuries, 193 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (221 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 761 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Extracardiac stimulation

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50951763 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort; Erosion; Medical device site infection

  MAUDE report 50940129 ↗
• InjurySep 29, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50937458 ↗
• 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 50897512 ↗
• MalfunctionAug 31, 2026Low impedance

  It was reported that the Left Ventricular (LV) lead exhibited Out of Range (OOR) low impedance. It was also reported that Right Atrial (RA) lead undersensing was observed resulting in unnecessary pacing and false termination of events. The RA lead and LV lead 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 50531560 ↗
• MalfunctionAug 14, 2026High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50262000 ↗
• MalfunctionJul 2, 2026Failure to Capture

  IT WAS REPORTED THAT A POSSIBLE LOSS OF CAPTURE OCCURRED; HOWEVER, IT COULD NOT BE DETERMINED WHETHER THE ISSUE WAS RELATED TO THE LEFT VENTRICULAR (LV) LEAD OR THE CARDIAC CONTRACTILITY MODULATION (CCM) DEVICE. THE LEAD REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25696124 ↗
• MalfunctionJun 30, 2026Failure to Capture; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE DUE TO HIGH AND VARIABLE LV THRESHOLDS. 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 25668061 ↗
• InjuryJun 18, 2026Over-Sensing; High Capture Threshold

  IT WAS REPORTED BY THE PATIENT REPRESENTATIVE THAT ONE OF THE "RIGHT VENTRICULAR (RV) LEAD PINS WAS NOT WORKING RIGHT." "THE RV LEAD COULD NOT BE INSERTED." THE "CYCLONE HAS RISEN AND "WON'T STAY IN THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)". "THE RV PIN WASN'T LONG ENOUGH TO STAY IN THE CRT-D". "THEY HAD DISCONNECTED THE RV LEAD FROM THE CRT-D AND SO THE PATIENT HAS TWO LEADS CURRENTLY ACTIVE". "THE RV LEAD DID NOT PLUG IN". THE RV LEAD REMAINS IN THE PATIENT. FOLLOW UP WITH THE CLINIC INDICATED THAT FOLLOWING A GENERATOR CHANGE OUT, THE RV LEAD EXHIBITED FAILURE TO CAPTURE AND HIGH PACING IMPEDANCE. THE DEVICE POCKET WAS REOPENED AND INSPECTION OF THE LEADS SHOWED THAT THE RV LEAD WAS CONNECTED TO THE HEADER SCREW, AND THE CONNECTOR PIN WAS SHORTER THAN EXPECTED. IT WAS NOTED THAT THE MECHANISM FOR THE SHORT PIN WAS UNCLEAR. THE PACE/SENSE PORTION OF THE RV LEAD WAS CAPPED, AND THE DEFIBRILLATION PORTION REMAINS IN USE. A NEW RV LEAD PACE/SENSE LEAD WAS ATTEMPTED, BUT THERE WAS OCCLUSION OF THE LEFT SUBCLAVIAN VENOUS SYSTEM AROUND THE OLDER LEADS. THE PHYSICIAN ELECTED TO PLUG THE LEFT VENTRICULAR (LV) LEAD INTO THE RV PACE/SENSE PORT AND PLUG THE LV PORT TO ALL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25552513 ↗
• MalfunctionJun 15, 2026Signal Artifact/Noise; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN IMPEDANCE WARNING FOR UNDEFINED HIGH PACING IMPEDANCES AND UNDEFINED HIGH RV DEFIBRILLATION IMPEDANCES. IN ADDITION, THE LEFT VENTRICULAR (LV) LEAD TRIGGERED AN IMPEDANCE WARNING FOR UNDEFINED HIGH PACING IMPEDANCES. IT WAS ALSO NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES. NOISE WAS ALSO NOTED ON THE RV, LV AND RA LEADS TRIGGERING EPISODE MISCLASSIFICATION. THE RV, LV AND RA 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 25504796 ↗
• MalfunctionJun 9, 2026High impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH IMPEDANCE. 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 25445424 ↗
• MalfunctionMay 27, 2026High impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRIGGERED AN ALERT FOR HIGH OUT OF RANGE (OOR) PACING IMPEDANCE. 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 25310652 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PATIENT EXPERIENCED AN INFECTION WITH VEGETATION NOTED IN THE RIGHT ATRIUM AND TRICUSPID VALVE. THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND THE REMAINDER OF THE SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 25219113 ↗
• MalfunctionMay 18, 2026Low impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOW OUT OF RANGE (OOR) PACING IMPEDANCE. IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A THRESHOLD ALERT. 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 25211048 ↗
• MalfunctionMay 4, 2026Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED AN INCREASE TO A SUDDEN ELEVATED CAPTURE THRESHOLD MEASUREMENT. THE LEAD REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070561 ↗
• InjuryApr 27, 2026Intermittent Capture; High Capture Threshold; Unstable Capture Threshold

  THE LV LEAD WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT STATED THEY FELT BETTER.

  Patient problems: Dizziness

  MAUDE report 25008922 ↗
• MalfunctionApr 21, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS NOT USED FOR IMPLANT DUE TO A LEAD MALFUNCTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24937482 ↗
• InjuryMar 23, 2026High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. 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 24663255 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY EIGHT MONTHS POST COMPETITOR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CHANGEOUT PROCEDURE, THE PATIENT NOTICED REDNESS, SWELLING, AND PURULENT DISCHARGE. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH INFECTION AND POCKET EROSION. THE MEDTRONIC RIGHT VENTRICULAR (RV) LEAD, LEFT VENTRICULAR (LV) LEAD, AND RIGHT ATRIAL (RA) LEADS WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 24627607 ↗
• MalfunctionMar 13, 2026Under-Sensing

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHBTIIED UNDER SENSING DURING VENTRICULAR DYSRHYTHMIA. 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 24597435 ↗
• InjuryFeb 17, 2026High Capture Threshold

  FOLLOW UP WITH THE CLINIC INDICATED THE LV LEAD WAS REPROGRAMMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24370538 ↗
• InjuryFeb 11, 2026High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED CHRONIC ELEVATED CAPTURE THRESHOLDS AND THE PATIENT WAS NOT RESPONDING TO CARDIAC RESYNCHRONIZATION THERAPY. THE LEAD WAS EXPLANTED WITH NO REPLACEMENT. IT WAS ALSO REPORTED THAT SENSING ON THE RIGHT VENTRICULAR (RV) LEAD WAS LOW AS THE LEAD EXHIBITED UNDERSENSING DURING A VENTRICULAR HIGH RATE EPISODE. 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 24315389 ↗
• InjuryFeb 10, 2026Failure to Capture; Low impedance; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISPLAYED OUT OF RANGE (OOR) LOW PACING IMPEDANCE AND NO CAPTURE. ADDITIONALLY, THE INSULATION OF THE LEAD WAS CUT AND DAMAGED. 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 24308336 ↗
• InjuryFeb 10, 2026Extracardiac stimulation; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLDS WITH PHRENIC NERVE STIMULATION. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 24306212 ↗
• InjuryFeb 9, 2026Fracture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH/UNDEFINED SUPERIOR VENA CAVA (SVC) IMPEDANCE MEASUREMENTS. IT WAS ALSO NOTED THAT DURING A GENERATOR CHANGE OUT PROCEDURE THE LEFT VENTRICULAR (LV) LEAD "SNAPPED IN TWO" WHILE FREEING THE LEAD FROM SCAR TISSUE AND A LOW VOLTAGE FRACTURE WAS CONFIRMED. THE RV LEAD REMAINS IN USE AND THE LV 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 24292330 ↗