Attain Ability™ Plus MRI SureScan™ 429688 (UDI 00643169601796)Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 00643169601796), received between Dec 9, 2016 and Apr 28, 2026 — classified as 32 injuries, 20 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (19 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Low impedance

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRIGGERED A WARNING FOR UNDEFINED LOW PACING 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 25019726 ↗
• InjuryNov 13, 2025Intermittent Capture; High Capture Threshold; Intermittent Capture; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND INTERMITTENT LV CAPTURE. THE RA AND LV LEADS WERE BOTH 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 23543049 ↗
• InjurySep 15, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) EXHIBITED PREMATURE DEPLETION. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED CHRONICALLY HIGH THRESHOLDS. THE DEVICE WAS REMOVED AND REPLACED. 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 23049005 ↗
• MalfunctionAug 19, 2025High Capture Threshold; High Capture Threshold

  IT WAS FURTHER REPORTED THAT THE LV LEAD CONTINUED TO EXHIBIT HIGH THRESHOLDS. IN ADDITION, THE RIGHT ATRIAL (RA) LEAD EXHIBITED UND ERSENSING TRIGGERING DEVICE CLASSIFIED FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENT(S) AT TIMES. THE LV AND RA 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 22843097 ↗
• MalfunctionAug 8, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THERE WAS CHRONIC HIGH THRESHOLD 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 22748201 ↗
• MalfunctionApr 22, 2025High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENSING. IT WAS ALSO REPORTED THAT THE EPICARDIAL LEAD EXHIBITED A HIGH PACING IMPEDANCE AND HIGH 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 21883060 ↗
• MalfunctionFeb 18, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD APPEARED TO BE PROGRAMMED SUBTHRESHOLD AND WAS NOT CAPTURING, RESULTING IN INEFFECTIVE CARDIAC RESYNCHRONIZATION THERAPY. 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 21394969 ↗
• InjuryDec 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO MONTHS POST IMPLANT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. THE LEFT VENTRICULAR (LV) LEAD WAS R EPROGRAMMED AND A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS PLACED AS BACKUP. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 21027095 ↗
• InjuryDec 11, 2024High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT ERRONEOUSLY HIGH LEFT VENTRICULAR CAPTURE MANAGEMENT THRESHOLDS WERE NOTED. THE LEFT VENTRICULAR (LV) LEAD AND CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) 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 20907124 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BULBOUS SKIN LESION OVER THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IMPLANT SITE. THE LESION WAS TREATED WITH A TOPICAL STEROID CREAM THAT RESULTED IN THE SKIN THINNING SO THE DEVICE COULD BE SEEN. THE CRT-D SYSTEM WAS EXPLANTED AND REPLACED. 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 19638672 ↗
• MalfunctionDec 22, 2023High Capture Threshold; Unstable Capture Threshold; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT RIGHT VENTRICULAR (RV) AND LEFT VENTRICULAR (LV) LEADS EXHIBITED SLIGHTLY HIGHER CAPTURE THRESHOLDS. DURING THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) DEVICE CHANGE-OUT, THE LV LEAD WAS CONNECTED INTO THE RV PORT AND THE RV LEAD WAS CONNECTED INTO THE LV PORT OF THE NEW CRTP DEVICE. VARIABLE CAPTURE THRESHOLD HAVE BEEN OBSERVED SINCE THE SWITCH OF LEADS IN THE HEADER. THE DEVICE FEATURE WHICH AUTOMATICALLY MONITORS PACING THRESHOLDS AT PERIODIC INTERVALS AND ADJUSTS OUTPUTS HAD INCREASED OUTPUTS, WHICH WAS CAUSING CONCERN ABOUT DECREASED BATTERY LIFE OF THE NEW CRTP DEVICE. THE LEADS AND NEW DEVICE ARE STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387354 ↗
• InjuryNov 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING USE OF THE RIGHT VENTRICULAR (RV) LEAD, THE LEAD WAS NOTED AS "JAILED" IN TRICUSPID VALVE. THE RV LEAD REMAINS IN USE.  IT WAS ALSO NOTED THAT THE PATIENT HAS STIMULATION UNLESS THE LEFT VENTRICULAR (LV) LEAD IS PROGRAMMED LVTIP TO CAN.  THE LV LEAD REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 18162082 ↗
• MalfunctionOct 2, 2023High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER-SENSING ON ATRIAL HIGH RATE EVENTS. THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A LEAD IMPEDANCE WARNING FOR HIGH UNDEFINED IMPEDANCE. THE RA AND LV 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 17850285 ↗
• InjuryJun 30, 2023Failure to Capture; Capturing Problem; Device Dislodged or Dislocated; Failure to Capture; Capturing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LV LEAD MAY HAVE PULLED BACK AND DISLODGED AS THE LEAD EXHIBITED INCREASING THRESHOLDS AND 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 17237371 ↗
• InjuryMar 22, 2023Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THERE WAS NO CAPTURE ON THE LEFT VENTRICULAR (LV) LEAD. DURING AN EXTRACTION PROCEDURE, A NEW LV LEAD WAS ATTEMPTED IN MULTIPLE BRANCHES, HOWEVER, IT ALSO EXHIBITED LOSS OF CAPTURE. THERE WERE NO OTHER APPROPRIATE LOCATIONS FOR THE LV LEAD. AN EPICARDIAL LEAD WAS PLACED TWO DAYS LATER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592813 ↗
• MalfunctionNov 28, 2022Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED POTENTIAL NON-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 15870116 ↗
• InjurySep 6, 2022Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED NON-CAPTURE AND HIGH THRESHOLDS. THE LV LEAD WAS INACTIVATED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15363209 ↗
• MalfunctionMay 17, 2022High Capture Threshold; Unstable Capture Threshold; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS OVER THE PAST YEAR. IT WAS ALSO NOTED THE LV LEAD HAS RECENTLY EXHIBITED UNSTABLE 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 14420013 ↗
• MalfunctionJul 29, 2021High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) WAS NOT FUNCTIONING WITHIN NORMAL TOLERANCES. THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS LATER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED CHRONIC 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 12246222 ↗
• InjuryApr 26, 2021Unstable Capture Threshold; Unstable Capture Threshold

  ADDITIONALLY, IT WAS REPORTED THAT REPROGRAMMING WAS PERFORMED FOR THE LEADS. IT WAS FURTHER CLARIFIED THAT THE RV LEAD MOVING WAS IN RELATIONSHIP TO MOVING/VARIABLE THRESHOLDS MEASUREMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11726269 ↗
• InjuryApr 5, 2021High Capture Threshold; High Capture Threshold

  FOLLOW UP CONCLUDED THAT THE PATIENT WAS SEEN IN THE CLINIC AND OUTPUTS WERE ADJUSTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11612799 ↗
• MalfunctionNov 25, 2020High Capture Threshold; High 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 10906737 ↗
• MalfunctionNov 20, 2020Capturing Problem; Impedance Problem; Capturing Problem; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD THRESHOLD AND IMPEDANCE HAVE RISEN. FOLLOW UP YIELDED NO INFORMATION. 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 10878451 ↗
• InjuryFeb 17, 2020Adverse 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 SEPSIS AND THE VEGETATION ON THE LEADS. CULTURES WERE TAKEN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 9716965 ↗
• InjuryDec 9, 2019Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION. THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE. IT WAS ADDITIONALLY NOTED THAT IN RESPONSE TO THE ADVISORY DESCRIBING THE POTENTIAL FOR DEVICE CIRCUIT ERROR TO OCCUR WHILE THE DEVICE IS PROCESSING AN ATRIAL-SENSED EVENT, THE IMPLANTABLE PULSE GENERATOR (IPG) SOFTWARE WAS UPDATED. THE DEVICE AND LEAD WERE REPROGRAMMED AND REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Stimulation

  MAUDE report 9439612 ↗