Attain AbilityRecalls & reported problems across all models

We found 2 models of Attain Ability by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 928 adverse event reports in the FDA's MAUDE database, received between Feb 25, 2013 and Sep 30, 2026 — classified as 9 deaths, 681 injuries, 238 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (278 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Attain Ability problems

Attain Ability models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Attain Ability® 419688

  permanent pacemaker Electrode
  9 deaths761 reports
• Attain Ability® 419678

  Drug eluting permanent left ventricular (lv) pacemaker electrode
  167 reports

Recent Attain Ability adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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