Attain Ability® Straight 439688Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 00613994719058), received between Jun 10, 2015 and Sep 16, 2026 — classified as 2 deaths, 95 injuries, 32 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (39 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 129 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026High Capture Threshold

  It was reported that the Right Ventricular (RV) 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 50785373 ↗
• InjuryMay 20, 2026Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED LOSS OF CAPTURE AND HIGH THRESHOLDS. THE LV 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 25235982 ↗
• InjuryApr 29, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT STATED THAT DUE TO ISSUES WITH THE LEFT VENTRICULAR (LV) LEAD THE HOSPITAL INITIATED EXTERNAL CARDIAC PACING. THE PATIENT REPORTED FEELING "POUNDING" SINCE THE LV LEAD WAS IMPLANTED. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 25031820 ↗
• InjuryApr 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV), RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) LEADS WERE EXPLANTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25008087 ↗
• InjuryApr 23, 2026Break; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH PACING IMPEDANCE AND SENSING INTEGRITY COUNTER (SIC). STORED EPISODES NOTED RV NOISE AND OVERSENSING RESULTING IN INHIBITION OF PACING AND MISCLASSIFICATION OF EPISODE TYPE. IT WAS NOTED THAT ¿IT APPEARED AS THOUGH A WIRE ISN'T CONNECTED¿. IT WAS FURTHER NOTED THAT A LOW VOLTAGE RV LEAD FRACTURE WAS SUSPECTED. THE RV LEAD WAS EXPLANTED AND REPLACED. DURING THE REPLACEMENT PROCEDURE, IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS ¿NOT RELIABLE AND DID NOT TEST WELL¿. IT WAS NOTED THAT THE LV LEAD ¿STOPPED WORKING AND DISINTEGRATED¿ WHEN THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS PULLED OUT OF THE POCKET. WHEN TESTED THROUGH CABLES, THE LV LEAD HAD NO CAPTURE. THE LV 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 24971089 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POCKET HAD WOUND DEHISCENCE AND WAS OOZING WITH PUS. THE PATIENT EXPERIENCED INFECTION, DISCOMFORT, EROSION, REDNESS AND SWELLING. THE CRT-D SYSTEM WAS EXPLANTED AND REPLACED WITH A TEMPORARY EXTERNAL IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM SO THE PATIENT COULD RECOVER FROM THE INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Medical device site infection; Pocket Erosion; Purulent Discharge; Wound Dehiscence

  MAUDE report 24841831 ↗
• InjuryApr 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POCKET HAD WOUND DEHISCENCE AND WAS OOZING WITH PUS. THE PATIENT EXPERIENCED INFECTION, DISCOMFORT, EROSION, REDNESS AND SWELLING. THE CRT-D SYSTEM WAS EXPLANTED AND REPLACED WITH A TEMPORARY EXTERNAL IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM SO THE PATIENT COULD RECOVER FROM THE INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Medical device site infection; Pocket Erosion; Purulent Discharge; Wound Dehiscence

  MAUDE report 24841830 ↗
• MalfunctionFeb 17, 2026High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. IT WAS ALSO REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH/UNDEFINED IMPEDANCE. THE LV LEAD AND RA 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 24369179 ↗
• MalfunctionNov 25, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD THRESHOLD WAS GREATER THAN THE PROGRAMMED AMPLITUDE. 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 23652872 ↗
• MalfunctionOct 20, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT SUSPECTED LOSS OF CAPTURE ON THE LEFT VENTRICULAR (LV) LEAD OCCURRED. 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 23335371 ↗
• MalfunctionSep 19, 2025Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THERE WAS AN INCREASE IN LEFT VENTRICULAR (LV) LEAD THRESHOLD MEASUREMENTS NOTED ON LEAD TRENDS. IT WAS ALSO NOTED THAT THE PATIENT WAS RECENTLY IN THE INTENSIVE CARE UNIT (ICU) DUE TO A DEVICE MALFUNCTION. THE LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 23102889 ↗
• MalfunctionSep 4, 2025Electrical /Electronic Property Problem; Low impedance; Electrical /Electronic Property Problem; Low impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT OUT OF RANGE (OOR) LOW IMPEDANCE WITH POLARITY SWITCH TRIGGERED WHILE THE PATIENT WAS IN THE HOSPITAL WITH INCREASED FLUID. THE LEAD REMAINS IN USE. 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 22962301 ↗
• MalfunctionJul 17, 2025Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE TELEMETRY NURSE OBSERVED POSSIBLE LOSS OF CAPTURE. NO PARTICULAR LEAD OR NUMBER OF LEADS WAS SPECIFIED. IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH CAPTURE THRESHOLDS. THE RIGHT VENTRICULAR (RV), RIGHT ATRIAL (RA), AND LV 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 22531388 ↗
• MalfunctionJul 10, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED BY THE PATIENT THAT THEIR LEFT VENTRICULAR (LV) LEAD WAS NOT MAKING A GOOD CONNECTION AND WAS DRAINING THE BATTERY OF THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE. THE LV LEAD AND CRT-D 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 22474714 ↗
• InjuryMay 21, 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 AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22061321 ↗
• InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SHORTLY AFTER THE NEW CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS IMPLANTED, THE PATIENT REPORTS "GETTING VIBRATIONS UNDER THEIR RIB CAGE". THE PATIENT HAD SOME OPTIMIZATION PROGRAMMING DONE FOR THEIR RATE SETTING AND CONTINUED TO GET "A LITTLE BIT" OF THE VIBRATION SENSATIONS. IT WAS FURTHER REPORTED THAT THE PATIENT WAS LATER SEEN FOR A DEVICE CHECK AND WAS TOLD THAT THE LEFT VENTRICULAR (LV) LEAD "WAS NOT WORKING WELL AT 2.5 VOLTS". THE VOLTAGE WAS CHANGED TO 3.5 VOLTS. THE NEXT DAY THE PATIENT "FELT LIKE THEIR HEART WAS COMING OUT OF THEIR CHEST WHEN THEY BENT OVER". THE PATIENT NOTED THAT THEY WERE INITIALLY TOLD THAT THE LEAD WAS CLOSE TO A NERVE AND WAS TOLD THEY MAY FEEL SOME SENSATION. THE PATIENT STARTED TO ACCOMMODATE TO IT. DUE TO THE PATIENT'S CONCERN REGARDING THE BATTERY OF THE DEVICE, THE LEAD WAS ULTIMATELY TURNED OFF. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue; Undesired Nerve Stimulation

  MAUDE report 21403454 ↗
• MalfunctionDec 10, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED BY THE PATIENT THAT ALL OF THEIR SYMPTOMS THAT THEY HAD WITH THEIR FIRST DEVICE CAME BACK WITH THEIR CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). ADDITIONALLY, THE PATIENT NOTED THAT THEY WERE INFORMED THAT THEY HAD DISCONNECTED A LEAD INTO THEIR LUNGS. THE CRT-D AND LEFT VENTRICULAR (LV) LEAD REMAIN 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 20897644 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION FROM A LEFT VENTRICULAR (LV) LEAD. ADDITIONALLY, THE OTHER LEFT VENTRICULAR (LV) LEAD EXHIBITED RISING THRESHOLDS. BOTH LEADS WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 20495207 ↗
• MalfunctionSep 30, 2024Failure to Capture; Failure to Capture

  ADDITIONAL INFORMATION RECEIVED NOTED THAT A TRANSMISSION WAS DONE AND NO EVIDENCE OF LOSS OF CAPTURE ON ANY LEAD WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20340486 ↗
• InjuryJul 11, 2024Break; Break

  IT WAS REPORTED THAT THERE WERE ALERTS FOR HIGH RIGHT VENTRICULAR (RV) LEAD DEFIBRILLATION IMPEDANCE AND VARYING RV COIL IMPEDANCE MEASUREMENTS WERE NOTED. IT WAS ALSO NOTED THAT NOISE WAS SEEN FROM THE RV COIL DURING IN CLINIC TESTING WHEN ISOMETRIC EXERCISES WERE PERFORMED. THE RV LEAD WAS LATER EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT DURING THE RV LEAD EXTRACTION THE LEFT VENTRICULAR (LV) LEAD WAS DAMAGED. THE LV 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 19721565 ↗
• MalfunctionJul 2, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) LEADS EXHIBITED HIGH PACING THRESHOLDS. 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 19658610 ↗
• MalfunctionJun 21, 2024Fracture; High impedance; Fracture; High impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISPLAYED OUT OF RANGE (OOR) HIGH PACING IMPEDANCE AND WAS POSSIBLY FRACTURED. 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 19582067 ↗
• InjuryApr 29, 2024Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED RISING 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 19209587 ↗
• InjuryApr 15, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH 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 19112788 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET 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 19112341 ↗