Attain Ability® Plus 429688Recalls & reported problems

Summary

The FDA's MAUDE database contains 529 adverse event reports that list this exact device (DI 00613994719133), received between Dec 10, 2013 and Sep 24, 2026 — classified as 11 deaths, 377 injuries, 141 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (152 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 529 reports, in the reporter's own words as published by the FDA.

• DeathSep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported by the patients representative that the patient implanted with a Cardiac Resynchronization Therapy Defibrillator (CRT-D) system "had a sepsis infection from "[the]" defibrillator ports" and "there was an infection on the lead from "[the]" defibrillator". The patient¿s representative reported the patient was "put on antibiotics instead of replacing as usually done". The patient expired approximately 8 weeks later.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 50883733 ↗
• MalfunctionSep 15, 2026Capturing Problem

  It was reported that the Left Ventricular (LV) lead exhibited an increase in capture 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 50777949 ↗
• MalfunctionAug 14, 2026Failure to Capture; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256776 ↗
• MalfunctionAug 11, 2026High Capture Threshold

  It was reported that the Left Ventricular (LV) lead exhibited high 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 50212264 ↗
• InjuryJul 31, 2026Extracardiac stimulation

  It was reported that the Left Ventricular (LV) lead was causing intermediate diaphragmatic stimulation. The patient elected to have the LV lead programmed off and electrically abandoned. The patient is a participant in a clinical study. No further patient complications have been reported as a result of this event.

  Patient problems: Inappropriate Device Stimulation of Tissue

  MAUDE report 50104298 ↗
• InjuryJul 29, 2026Capturing Problem

  It was reported that progressively increasing Left Ventricular (LV) lead thresholds were observed over the course of two months. LV lead vectors were tested, the lead was reprogrammed and 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 50074817 ↗
• MalfunctionJun 24, 2026Capturing Problem; Impedance Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED INCREASING CAPTURE THRESHOLDS WITH A CORRELATING INCREASE IN IMPEDANCE MEASUREMENTS. THE PATIENT EXPERIENCED CHEST PAIN. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain

  MAUDE report 25616646 ↗
• MalfunctionJun 12, 2026Failure to Capture; Impedance Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A DROP IN PACING IMPEDANCE AND POTENTIAL LOSS OF CAPTURE. 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 25491448 ↗
• MalfunctionMay 12, 2026High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRENDS NOTED CHRONICALLY HIGH THRESHOLDS AND 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 25156337 ↗
• InjuryMay 11, 2026Adverse 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 25144970 ↗
• MalfunctionMay 11, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING RESULTING IN OVER PACING. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD. 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 25140079 ↗
• InjuryMay 6, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS CAPPED AND REPLACED DUE TO 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 25095485 ↗
• MalfunctionApr 21, 2026Failure to Capture

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) LEAD EXHIBITED LEAD IMPEDANCE WARNING FOR UNDEFINED HIGH RV DEFIBRILLATION IMPEDANCE, UN DEFINED HIGH SUPERIOR VENA CAVA (SVC) DEFIBRILLATION IMPEDANCE, AND UNDEFINED HIGH RV TIP TO RV COIL PACING IMPEDANCE. THE LEFT VENTRICULAR (LV) LEAD ALSO EXHIBITED LOSS OF CAPTURE. 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 24945782 ↗
• InjuryMar 23, 2026Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN WITH REDNESS AND PURULENT DISCHARGE/PUS OBSERVED AND A DEVICE POCKET INFECTION WAS NOTED. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. UPON TRYING TO EXTRACT THE LEFT VENTRICULAR (LV) LEAD THE LEAD BROKE OFF, ATTEMPTS WERE MADE TO REMOVE THE REMAINING LEAD HOWEVER THE LEAD TIP WAS TOO EMBEDDED IN THE CS AND WAS LEFT IN THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Medical device site infection; Pain; Purulent Discharge

  MAUDE report 24667642 ↗
• MalfunctionMar 12, 2026High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED VARYING AND 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 24579003 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND SUBSEQUENTLY REPLACED DUE TO AN INFECTION WITH BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 24548982 ↗
• InjuryFeb 4, 2026Positioning Problem

  IT WAS REPORTED THAT ONE DAY POST LEFT VENTRICULAR (LV) LEAD IMPLANT, THE LEAD RETRACTED. 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 24259027 ↗
• InjuryFeb 2, 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. THE PATIENT EXPERIENCED BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 24235324 ↗
• InjuryJan 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS POST IMPLANT THE PATIENT EXPERIENCED DISCOMFORT, PAIN AND REDNESS. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND REPLACED DUE TO INFECTION AND EROSION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erosion; Erythema; Pain; Unspecified Infection

  MAUDE report 24012411 ↗
• MalfunctionJan 8, 2026Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS USED OFF LABEL AS IT WAS IMPLANTED IN ATRIAL PORT, THE LV LEAD EXHIBITED 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 24003811 ↗
• InjuryDec 23, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED POST-FALL. IT WAS UNKNOWN IF IT WAS A MECHANICAL FALL VERSUS SYNCOPE. A DEVICE INTERROGATION INDICATED THAT CAPTURE COULD NOT BE CONFIRMED ON THE LEFT VENTRICULAR (LV) LEAD. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fall; Syncope/Fainting

  MAUDE report 23875589 ↗
• MalfunctionDec 2, 2025High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA (AT) /ATRIAL FIBRILLATION (AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS. IT WAS FURTHER REPORTED THAT AN ALERT WAS TRIGGERED FOR HIGH OUT OF RANGE (OOR) PACING IMPEDANCE ON THE LEFT VENTRICULAR (LV) LEAD. THE LEADS 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 23697886 ↗
• InjuryNov 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY'D FELT A PULSING SENSATION, ALMOST LIKE A TWITCH, IN THE LOWER PART OF THEIR HEART FOR A COUPLE OF YEARS AND IT WAS INCREASING IN FREQUENCY. THE PATIENT WOULD FEEL IT WHEN SITTING, STANDING, OR LYING DOWN BUT NOT WHEN MOVING AROUND. APPROXIMATELY TWO WEEKS LATER, THE PATIENT REPORTED FEELING MUSCLE STIMULATION FOR THE LAST FEW YEARS. TWO MONTHS LATER, THE PATIENT REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS INACTIVATED DUE TO DIAPHRAGMATIC STIMULATION. THE LEAD REMAINS IN PLACE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue; Twitching

  MAUDE report 23576553 ↗
• InjuryNov 13, 2025Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED INCREASING IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED AS IT COULD NOT BE REVISED OR EXTRACTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541295 ↗
• InjuryNov 6, 2025Capturing Problem; Capturing Problem

  IT WAS FURTHER REPORTED THAT THE LV LEAD WAS REPROGRAMMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23491142 ↗