Attain Ability® 419678Recalls & reported problems

Summary

The FDA's MAUDE database contains 167 adverse event reports that list this exact device (DI 00613994469724), received between Apr 9, 2013 and Sep 8, 2026 — classified as 122 injuries, 45 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (57 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 167 reports, in the reporter's own words as published by the FDA.

• InjurySep 8, 2026Failure to Capture; Impedance Problem; High Capture Threshold

  It was reported that the Left Ventricular (LV) lead exhibited a rise in impedance, high thresholds, and it could not capture. The LV lead was programmed off. It was also reported that the Right Ventricular (RV) lead had issues with pacing thresholds. 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 50675878 ↗
• InjuryJun 15, 2026Break

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WITH DUAL CHAMBER SENSING CAPABILITY EXHIBITED HIGH CAPTURE THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED. DURING THE REPLACEMENT PROCEDURE, THE LEFT VENTRICULAR (LV) LEAD'S INSULATION WAS DAMAGED. THE LV LEAD WAS PARTIALLY REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25504065 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A DEVICE POCKET INFECTION WITH DISCOMFORT, REDNESS, AND SWELLING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Swelling/ Edema; Unspecified Infection

  MAUDE report 24874495 ↗
• MalfunctionMar 31, 2026Failure to Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM. THERE WAS POSSIBLE LOSS OF CAPTURE ON THE LEFT VENTRICULAR (LV) LEAD. 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 24741982 ↗
• MalfunctionFeb 12, 2026Electrical /Electronic Property Problem; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITS PERFORATION AND CALCIFICATION. IT WAS FURTHER REPORTED THAT THE LEFT V ENTRICULAR (LV) LEAD TRIGGERED AN ALERT FOR HIGH OUT OF RANGE (OOR) PACING IMPEDANCE AND EXPERIENCED A POLARITY SWITCH. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING. THE RA LEAD WAS REPROGRAMMED AND ALL 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 24327256 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED EXTRACARDIAC STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. A MONTH LATER DURING AN OFFICE VISIT, THE PATIENT REPORTED SYMPTOMS THAT SOUND LIKE DIAPHRAGMATIC STIMULATION. THE SYMPTOMS WERE REPRODUCED BY INCREASING THE LV LEAD OUTPUT. THE LV LEAD WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 23818549 ↗
• InjuryDec 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED SWELLING AND DISCOMFORT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; No Clinical Signs, Symptoms or Conditions; Swelling/ Edema; Unspecified Infection

  MAUDE report 23720117 ↗
• MalfunctionNov 13, 2025High Capture Threshold; High 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 23544061 ↗
• MalfunctionOct 27, 2025Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A POSSIBLE CAPTURE ISSUE. IT WAS NOTED THAT THE PATIENT HAD A FALL AND EXPERIENCED HYPOTENSION. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fall; Low Blood Pressure/ Hypotension

  MAUDE report 23394664 ↗
• InjuryOct 22, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE MEASUREMENTS AND A SUPERIOR VENA CAVA (SVC) COIL FRACTURE WAS CONFIRMED. IN ADDITION, THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE RV LEAD WAS EXPLANTED AND REPLACED. THE LV LEAD WAS PARTIALLY REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23359343 ↗
• InjuryAug 18, 2025Appropriate Device Problem Term/Code Not Available; High Capture Threshold; Appropriate Device Problem Term/Code Not Available; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THE RA LEAD EXHIBITED NOISE AND THE LV LEAD EXHIBITED HIGH THRESHOLDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22829066 ↗
• InjuryAug 13, 2025High Capture Threshold; High 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 22795535 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED APPROXIMATELY TWO WEEKS POST-GENERATOR REPLACEMENT PROCEDURE DUE TO REDNESS AND SUSPECTED POCKET INFECTION. A NEW SYSTEM WAS IMPLANTED THE FOLLOWING WEEK. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Medical device site infection

  MAUDE report 22322337 ↗
• MalfunctionJun 6, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS RESULTING IN A LOW DEVICE BATTERY LONGEVITY ESTIMATE. 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 22157062 ↗
• MalfunctionJun 3, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED POSSIBLE LOSS OF CAPTURE. 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 22134538 ↗
• MalfunctionApr 25, 2025Failure to Capture; Unstable Capture Threshold; Failure to Capture; Unstable Capture Threshold

  IT WAS FURTHER REPORTED THE FOLLOWING MONTH THAT THE LV LEAD EXHIBITED VARIABLE CAPTURE THRESHOLDS AND THE PATIENT HAD PAUSE EPISODES.

  Patient problems: Bradycardia; Non specific EKG/ECG Changes

  MAUDE report 21913487 ↗
• MalfunctionApr 24, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH AND UNDEFINED IMPEDANCE MEASUREMENTS PREVENTING THE DEVICE FEATURE THAT ALLOWS A PATIENT TO UNDERGO A MAGNETIC RESONANCE IMAGING (MRI) SCAN UNDER SPECIFIED MRI CONDITIONS TO BE PROGRAMMED ON. 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 21902760 ↗
• MalfunctionMar 20, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED FAILURE TO CAPTURE ON RHYTHM STRIPS. THE LV 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 21655084 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION. IT WAS NOTED THAT THE RV LEAD WAS PARTIALLY EXPLANTED, WITH THE DISTAL PORTION REMAINING IN THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21597098 ↗
• InjuryFeb 26, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NO ATRIAL CAPTURE, AND THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLDS. BOTH LEADS 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 21473534 ↗
• InjuryFeb 20, 2025High impedance; Positioning Problem; High Capture Threshold; High impedance; Positioning Problem; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD PLACEMENT WAS POOR DURING THE IMPLANT PROCEDURE DUE TO THE PATIENT'S ANATOMY, RESULTING IN HIGH LV THRESHOLDS. 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 21425948 ↗
• InjuryFeb 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION. THE LEFT VENTRICULAR (LV) LEAD WAS PROGRAMMED OFF. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 21363490 ↗
• MalfunctionJan 8, 2025High impedance; High impedance

  IT WAS REPORTED APPROXIMATELY FOUR MONTHS LATER THAT OUT OF RANGE IMPEDANCE WAS NOTED AHEAD OF A POTENTIAL MAGNETIC RESONANCE IMAGING (MRI) SCAN. NO SPECIFIC LEAD WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102841 ↗
• InjuryOct 31, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE PATIENT REPORTED PERFORMANCE ISSUE OF CLINIC COULD NOT PROGRAM THE CRT-D COULD NOT BE CONFIRMED. IT WAS NOTED THAT PROGRAMMING CHANGES WERE IMPLEMENTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20582891 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse 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. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20182114 ↗