Attain Ability® Plus 429678Recalls & reported problems

Summary

The FDA's MAUDE database contains 114 adverse event reports that list this exact device (DI 00613994719171), received between Aug 9, 2013 and Aug 18, 2026 — classified as 2 deaths, 86 injuries, 26 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (36 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 114 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2026High Capture Threshold

  It was reported that the Left Ventricular (LV) lead exhibited high thresholds and the Cardiac Resynchronization Therapy Defibrillator (CRT-D) experienced rapid battery depletion. The LV lead was capped and replaced and the CRT-D 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 50306986 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING A STAPHYLOCOCCI INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25237284 ↗
• MalfunctionApr 15, 2026High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT IS VERY SICK AND HAS BEEN IN THE HOSPITAL.  IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EX HIBITED HIGH AND VARIABLE THRESHOLDS AND THE CURRENT ELECTROGRAMS (EGM) SHOWED POSSIBLE ATRIAL LOSS OF CAPTURE.  THE RA LEAD REMAINS IN USE.  IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS.  THE LV LEAD REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24886808 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS IN A SUBOPTIMAL POSITION SINCE IMPLANT. DURING A LEAD REVISION PROCEDURE, THE PATIENT CODED AND THEIR BLOOD PRESSURE DROPPED WHILE THE RIGHT ATRIAL (RA) LEAD AND LV LEAD WERE ATTEMPTED TO BE EXTRACTED. THE PATIENT RECEIVED CARDIOPULMONARY RESUSCITATION AND AN OPERATING ROOM TEAM WAS CALLED. A SMALL TEAR WAS FOUND IN THE LATERAL INNOMINATE- SUPERIOR VENA CAVA (SVC) JUNCTION THAT WAS REPAIRED VIA STERNOTOMY AND THE PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. THE LEADS WERE EXPLANTED AND REPLACED WITH EPICARDIAL LEADS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Great Vessel Perforation; Hemodynamic instability

  MAUDE report 24877852 ↗
• InjuryMar 18, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD BECAME DISLODGED FROM THE CORONARY SINUS FOR A SECOND TIME AND VENTRICULAR FUNCTION DECLINED. THE LEAD WAS EXPLANTED, REPLACED AND THE PATIENT'S VASCULAR FUNCTION IMPROVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24627854 ↗
• InjuryMar 18, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD BECAME DISLODGED FROM THE CORONARY SINUS THE SAME YEAR IT WAS IMPLANTED AND VENTRICULAR FUNCTION DECLINED. THE LEAD WAS REVISED AND VENTRICULAR FUNCTION IMPROVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24627768 ↗
• InjuryJan 7, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD DISLODGED. 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 23990684 ↗
• MalfunctionDec 26, 2025Low impedance; Unstable Capture Threshold; Low impedance; Unstable Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED OUT OF RANGE LOW PACING IMPEDANCE AND VARIABLE 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 23896006 ↗
• InjuryAug 26, 2025Capturing Problem; High Capture Threshold; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THERE WAS RISING AND HIGH THRESHOLD ON THE LEFT VENTRICULAR (LV) LEAD. 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 22894401 ↗
• InjuryMar 20, 2025Intermittent Capture; Fracture; High impedance; Impedance Problem; High Capture Threshold; Unstable Capture Threshold; Intermittent Capture; Fracture; High impedance; Impedance Problem; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THERE WAS INTERMITTENT CAPTURE, UNSTABLE THRESHOLD, HIGH THRESHOLD, RISING AND HIGH IMPEDANCE, AND A SUSPECTED FRACTURE ON THE LEFT VENTRICULAR (LV) LEAD. 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 21651534 ↗
• MalfunctionJan 31, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS BECAUSE OF THE WAY THE AUTOMATIC ALGORITHM THAT MONITORS THE PACING AMPLITUDE THRESHOLD AND ADJUSTS LV OUTPUTS WAS OPERATING. IN OFFICE MEASUREMENTS OF LV LEAD THRESHOLDS WERE WITHIN NORMAL LIMITS. 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 21284850 ↗
• InjuryJan 3, 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 METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS BACTEREMIA INFECTION. IT WAS NOTED THAT THE SOURCE OF THE INFECTION WAS INTRAVENOUS (IV) DRUG USE; HOWEVER, VEGETATION WAS NOTED ON THE RIGHT VENTRICULAR (RV) LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 21072443 ↗
• InjuryNov 18, 2024High impedance; Adverse Event Without Identified Device or Use Problem; High impedance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. THE LV LEAD TRIGGERED A WARNING FOR HIGH UNDEFINED IMPEDANCE. THE LV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 20710426 ↗
• DeathJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS DECEASED AND THE CAUSE OF DEATH IS UNKNOWN. IT WAS FURTHER NOTED THAT APPROXIMATELY ONE YEAR PRIOR TO THE PATIENT¿S DEATH, A LARGE SKIN LESION WAS NOTED DIRECTLY OVER THE DEVICE SITE AND WAS DIAGNOSED AS FUNGATING SQUAMOUS CELL CARCINOMA AND THE CANCEROUS LESION WAS EXCISED THE FOLLOWING MONTH. THE CANCEROUS LESION GREW BACK QUICKLY REQUIRING A DEEPER EXCISION WHICH WOULD EXTEND INTO THE DEVICE AREA AND THE DEVICE WAS REMOVED AND THE RIGHT ATRIAL (RA) LEAD, RIGHT VENTRICULAR (RV) LEAD, AND LEFT VENTRICULAR (LV) LEAD WERE CUT AND CAPPED, AND A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. APPROXIMATELY NINE MONTHS LATER, THE PATIENT PRESENTED TO THE DEVICE CLINIC AND THE CUT/CAPPED RA LEAD, RV LEAD, AND LV LEAD HAD ERODED AND WERE CLEARLY EXPOSED. THE PATIENT SUBSEQUENTLY EXPIRED THE FOLLOWING MONTH. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY.

  Patient problems: Erosion; Insufficient Information

  MAUDE report 19756174 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIAPHRAGMATIC STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. THE LEAD WAS REPROG RAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 18975277 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BLOOD INFECTION WHICH INFECTED THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICE AND LEADS. THE PACING SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18857639 ↗
• InjuryFeb 8, 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 AND REPLACED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18671657 ↗
• DeathJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY.

  Patient problems: Heart Block; Pulmonary Embolism; Skin Inflammation/ Irritation; Swelling/ Edema; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 18499155 ↗
• InjuryJan 8, 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 AND REPLACED DUE TO INFECTION. BACTEREMIA AND SEPSIS WERE NOTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Sepsis; Unspecified Infection

  MAUDE report 18466449 ↗
• MalfunctionDec 15, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT WENT IN FOR AN OFFICE VISIT AND WAS FOUND TO HAVE HAD CHRONICALLY ELEVATED BUT STABLE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD THRESHOLDS. PREMATURE BATTERY DEPLETION OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOTED. THE DEVICE AND RV LEAD WERE REPROGRAMMED. THREE MONTHS AFTER THE OFFICE VISIT, THE PATIENT HAD THEIR DEVICE EXPLANTED AND REPLACED. 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 18336386 ↗
• InjuryDec 14, 2023Adverse 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 FROM THE LEFT VENTRICULAR (LV) LEAD. THE LV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 18330353 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 18276919 ↗
• MalfunctionNov 14, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH 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 18131955 ↗
• InjuryOct 26, 2023Failure to Capture; Device Dislodged or Dislocated; High Capture Threshold; Failure to Capture; Device Dislodged or Dislocated; High Capture Threshold

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION DUE TO HIGH THRESHOLD MEASUREMENTS OF THE LEFT VENTRICULAR (LV) LEAD. IT WAS NOTED THAT THE LV LEAD EXHIBITED NO CAPTURE AND DISLODGMENT POST POCKET CLOSURE. THE DEVICE AND LEAD 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 18008734 ↗
• MalfunctionOct 5, 2023Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THE PATIENT SUSPECTED THEIR LEADS WERE MOVING AROUND. FOLLOW UP YIELDED NO INFORMATION. THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (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 17877377 ↗