Attain Ability® Straight 439678Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00613994719096), received between Jun 9, 2017 and Feb 26, 2026 — classified as 18 injuries, 8 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (7 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Failure to Capture

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CONGESTIVE HEART FAILURE. BIVENTRICULAR CAPTURE COULD NOT BE CONFIRMED VIA DEVICE IN TERROGATION. THE RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEADS REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24453605 ↗
• InjuryMar 10, 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 21562201 ↗
• InjuryJan 30, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH BUT, STABLE THRESHOLD. THE LV LEAD WAS EXPLANTED AND REPLACED TO IMPROVE LONGEVITY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21272906 ↗
• InjuryMar 22, 2024Electrical /Electronic Property Problem; Capturing Problem; High Capture Threshold; Unstable Capture Threshold; Electrical /Electronic Property Problem; Capturing Problem; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS THAT CONTRIBUTED TO PREMATURE BATTERY DEPLETION OF THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P). THE LV LEAD WAS REPROGRAMMED IN ATTEMPT TO CONSERVE THE REMAINING LONGEVITY OF THE DEVICE. APPROXIMATELY ONE WEEK LATER, THE PATIENT EXPERIENCED EXTRACARDIAC STIMULATION FROM THE LEAD. THE LEAD WAS THEN PROGRAMMED BACK TO THE PREVIOUS SETTING. THE DEVICE AND LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 18958455 ↗
• MalfunctionJan 25, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TRIGGERED A FALSE OBSERVATION FOR AN INCREASE IN THE LV LEAD THRESHOLD INDICATING THAT THE INCREASE WAS GREATER THAN THE AMPLITUDE SAFETY MARGIN AND MAY HAVE COMPROMISED CAPTURE. THE OBSERVATION DISPLAYED QUESTION MARKS WHERE A NUMERICAL VALUE WOULD TYPICALLY BE DISPLAYED. THE CRT-D REMAINS IN USE. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD THRESHOLDS WERE GREATER THAN THE LV LEAD OUTPUT. 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 18581055 ↗
• MalfunctionNov 16, 2023High impedance; High impedance

  IT WAS REPORTED THAT AN ALERT WAS TRIGGERED FOR HIGH, UNDEFINED IMPEDANCE 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 18155442 ↗
• InjuryAug 28, 2023Break; Break

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS INCIDENTALLY CUT WITH BOVIE CAUTERY DURING A GENERATOR CHANGE. THE LEAD WAS CAPPED WITH NO REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17630286 ↗
• InjuryAug 25, 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 APPROXIMATELY EIGHT YEARS POST CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM IMPLANT. IT WAS DISCOVERED THAT A SURGICAL SPONGE HAD BEEN LEFT IN THE POCKET. THE PATIENT EXPERIENCED DISCOMFORT, PAIN AND SWELLING. THE CRT-P WAS REPORTEDLY PLACED BACK IN THE POCKET; HOWEVER, THE SYSTEM WAS REMOVED A FEW DAYS LATER AND A SINGLE CHAMBER PACEMAKER SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 17627736 ↗
• InjuryApr 4, 2023High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AFTER THE DEVICE CHANGEOUT. THE LEAD WAS PROGRAMMED OFF AND REMAINS IN PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16676095 ↗
• InjuryMar 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 16469256 ↗
• MalfunctionJan 31, 2023Low impedance; Low impedance

  IT WAS REPORTED THAT DURING USE OF THE LEFT VENTRICULAR (LV) LEAD A LEAD IMPEDANCE WARNING TRIGGERED FOR LOW 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 16272800 ↗
• InjuryAug 12, 2022Intermittent Capture; Capturing Problem; High Capture Threshold; Intermittent Capture; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT DURING USE THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD AND UNABLE TO MAINTAIN LEFT VENTRICULAR CAPTURE.  IT WAS ALSO REPORTED THAT 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; Dyspnea; Fatigue; No Clinical Signs, Symptoms or Conditions; Sleep Dysfunction; Swelling/ Edema

  MAUDE report 15216544 ↗
• InjuryOct 13, 2021Failure to Capture; High impedance; High Capture Threshold; Failure to Capture; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLDS, HIGH UNDEFINED IMPEDANCE AND NO CAPTURE IN ANY CONFIGURATION. 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 12624403 ↗
• MalfunctionSep 7, 2021Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A GRADUAL INCREASE IN PACING 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 12431804 ↗
• MalfunctionApr 26, 2021High Capture Threshold; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THE PATIENT GENERALIZED WEAKNESS/ DIZZINESS WAS ATTRIBUTED TO BEING IN ATRIAL FLUTTER FOR ABOUT 72 HOURS AND NO ACTION/ INTERVENTION TAKEN FOR THE RA OR RV LEADS.

  Patient problems: Muscle Weakness/Atrophy

  MAUDE report 11724668 ↗
• InjuryMar 16, 2021Material Integrity Problem; Material Integrity Problem

  THE RIGHT VENTRICULAR (RV) LEAD THAT WAS ELECTIVELY EXPLANTED AND REPLACED WAS RETURNED AND ANALYZED. THE RV LEAD TESTED OUT OF SPECIFICATION FOR THE OUTER INSULATION BEING RUPTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11495919 ↗
• InjuryJan 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED DUE TO A POCKET EROSION AND THE LEADS WERE VISIBLE THROUGH A HOLE IN THE SKIN. A LEADLESS PACEMAKER WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 11131140 ↗
• InjuryMay 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INFECTION OCCURRED. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 10079267 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED DUE TO SEPSIS AND DEHYDRATION. THE PATIENT RECEIVED TREATMENT AND WAS DISCHARGED. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM REMAINED IN USE. THE PATIENT IS A PARTICIPANT IN THE (B)(6) CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis

  MAUDE report 9330213 ↗
• InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE DEVICE AND LEADS WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 8318265 ↗
• MalfunctionOct 31, 2018High impedance; High impedance

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE THERAPY DUE TO NOISE AND A CONFIRMED FRACTURE OF THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THAT THE RV LEAD HAD HIGH AND UNDEFINED IMPEDANCE MEASUREMENTS. IT WAS ALSO NOTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH IMPEDANCE MEASUREMENTS. THE RV LEAD WAS EXPLANTED AND REPLACED. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8025416 ↗
• InjuryJul 23, 2018Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 7711176 ↗
• InjuryJul 16, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION ON THE LEFT VENTRICULAR (LV) LEAD. THE LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Stimulation

  MAUDE report 7692130 ↗
• MalfunctionJul 6, 2018Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE ATRIAL AND VENTRICULAR LEADS EXHIBITED OVERSENSING OF NOISE. BOTH LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7666367 ↗
• InjuryMay 16, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD DISLODGED. THE LV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient; Undesired Nerve Stimulation

  MAUDE report 7518970 ↗