Attain Ability™ Straight MRI SureScan™ 439688 (UDI 00643169860230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00643169860230), received between Apr 25, 2018 and Sep 3, 2026 — classified as 1 death, 32 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Failure to Capture” (11 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 46 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Extracardiac stimulation

  It was reported that the Left Ventricular (LV) lead patient was feeling a thumping in their abdomen while laying on their left side. The patient was stated to have underlying rhythm of Complete Heart Block. Reprogramming was performed and the thumping in the patient abdomen ceased.  The patient is a participant in a clinical study. The lead remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Device Overstimulation of Tissue; Heart Block

  MAUDE report 50588565 ↗
• MalfunctionFeb 27, 2026Capturing Problem; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED A SPIKE IN CAPTURE THRESHOLD AND HIGH THRESHOLDS. IT WAS NOTED THAT THERE WAS A JUMP IN LV LEAD IMPEDANCE AS WELL. 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 24474483 ↗
• MalfunctionFeb 25, 2026High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS ABOVE 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 24444267 ↗
• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED FAR FIELD R-WAVE (FFRW) OVERSENSING. THE LEAD REMAINS IN USE. IT WAS ALSO NOTED THAT THE PATIENT HAD EXPERIENCED EXTRACARDIAC STIMULATION FROM THE PACING LEAD IMPLANTED IN THE MIDDLE CARDIAC VEIN. THE LEAD WAS REPROGRAMMED SUBTHRESHOLD AND REMAINS IN SITU. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23369212 ↗
• InjuryJul 30, 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 A POCKET INFECTION WITH REDNESS, SWELLING, AND PURULENT DISCHARGE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Medical device site infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 22666756 ↗
• MalfunctionMar 17, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED 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 21621159 ↗
• MalfunctionMar 7, 2025Failure to Capture; Adverse Event Without Identified Device or Use Problem; High Capture Threshold; Failure to Capture; Adverse Event Without Identified Device or Use Problem; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. IT WAS ALSO NOTED THAT THE LV LEAD EXHIBITED HIGH THRESHOLDS AND OCCASIONAL LOSS OF CAPTURE. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 21551937 ↗
• InjuryFeb 19, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE LV LEAD WAS EXPLANTED AND REPLACED WITH A LEFT BUNDLE BRANCH PACING LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415413 ↗
• InjurySep 20, 2024Break; Break

  IT WAS REPORTED THAT DURING THE REPLACEMENT PROCEDURE, THE OUTER INSULATION OF THE LEFT VENTRICULAR (LV) LEAD WAS DAMAGED WITH ELECT ROCAUTERY AFTER OPENING THE POCKET, EXPOSING THE LEADS AND RESECTING THE SCAR TISSUE. THE LEAD WAS TESTED THOROUGHLY WITH NO ELECTRICAL ABNORMALITIES. THE PHYSICIAN DECIDED TO SUTURE A LEAD ANCHORING SLEEVE OVER THE SMALL AREA WHERE THE INSULATION WAS DAMAGED. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD AN INCREASE TO HIGH THRESHOLD MEASUREMENT. THE REASON FOR THE RV LEAD CHRONIC CAPTURE THRESHOLD INCREASE IS UNKNOWN. BOTH 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 20267982 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A POCKET INFECTION APPROXIMATELY FIVE MONTHS AFTER THE IMPLANT OF A CARDIAC RESYNCHRONIZA TION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WITH AN ABSORBABLE ENVELOPE. PURULENT DISCHARGE/PUS AND REDNESS WERE NOTED. THE DEVICE SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Purulent Discharge; Unspecified Infection

  MAUDE report 19920877 ↗
• InjuryJun 13, 2024High impedance; Impedance Problem; High impedance; Impedance Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD, WHICH IS PLUGGED INTO THE RIGHT VENTRICULAR (RV) LEAD PORT, EXHIBITED A GRADUAL INCREASE IN IMPEDANCE AND IS NOW HIGH AND UNDEFINED. 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 19528562 ↗
• InjuryApr 22, 2024Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS POST IMPLANT THE LEFT VENTRICULAR (LV) LEAD "PULLED BACK". IT WAS NOTED THAT THERE WAS POSITIONING AND PLACEMENT ISSUES DURING IMPLANT THAT WERE ATTRIBUTED TO THE PATIENT'S ANATOMY. 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 19157370 ↗
• InjuryMar 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD DISLODGED AND ATTEMPTS TO REPOSITION IT WERE UNSUCCESSFUL. 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 18831615 ↗
• DeathFeb 28, 2024Failure to Capture; Impedance Problem; Failure to Capture; Impedance Problem

  IT WAS LATER REPORTED THAT THE PATIENT EXPIRED WHILE ON HOSPICE CARE APPROXIMATELY TWO AND A HALF WEEKS LATER. ADDITIONAL INFORMATION WAS REQUESTED BUT COULD NOT BE OBTAINED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18796252 ↗
• InjuryFeb 26, 2024Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT ONE DAY POST IMPLANT THE LEFT VENTRICULAR (LV) LEAD WAS NONFUNCTIONING WITH NO CAPTURE. THE LV LEAD WAS REPROGRAMMED SUBTHRESHOLD. IT WAS NOTED THAT THE LV LEAD WAS INSERTED IN THE RIGHT VENTRICULAR (RV) LEAD PORT OF THE IMPLANTED DEVICE, THIS IS CONSIDERED OFF LABEL USE. DUE TO THE ANATOMICAL LOCATION OF THE LEAD AND THE LEAD BEING INSERTED IN THE RV PORT THE THE DEVICE FEATURE THAT AUTOMATICALLY MONITORS PACING THRESHOLDS AT PERIODIC INTERVALS WAS NOT RUNNING. 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 18783062 ↗
• InjuryNov 28, 2023High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DEVELOPED HIGH THRESHOLD AND HIGH OUT OF RANGE IMPEDANCE. DURING THE PROCEDURE, THE RV LEAD WAS DISCONNECTED FROM THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AND TESTED BY AN ANALYZER WHICH VERIFIED HIGH THRESHOLD AND HIGH IMPEDANCE. THE RV LEAD WAS EXPLANTED AND REPLACED. THE NEW RV LEAD WAS TESTED THROUGH THE ANALYZER WITH NORMAL RANGES FOR ALL TESTS. HOWEVER, UPON CONNECTING ALL THE LEADS TO THE DEVICE, TESTING WAS PERFORMED WHICH SHOWED THE RV LEAD TO HAVE HIGH IMPEDANCE AND NO CAPTURE. THE RV LEAD WAS RETESTED THROUGH THE ANALYZER WHICH SHOWED TESTING VALUES WITHIN NORMAL RANGE. THE CRT-P WAS EXPLANTED AND REPLACED WITH NORMAL TESTING VALUES ON ALL THE LEADS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18223588 ↗
• MalfunctionNov 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE LEFT VENTRICULAR (LV) LEAD PULLED BACK DUE TO A SMALL TARGET VESSEL. THE LV LEAD WAS REMOVED AND A LEAD WITH ACTIVE FIXATION WAS IMPLANTED INSTEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155376 ↗
• InjuryAug 14, 2023Adverse 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. THE PATIENT WAS TREATED WITH ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17546306 ↗
• InjuryJul 14, 2023Failure to Capture; Under-Sensing; Failure to Capture; Under-Sensing

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD, WHICH WAS PLUGGED INTO THE RIGHT VENTRICULAR PORT ON THE PACEMAKER, EXHIBITED LOSS OF CAPTURE AND POSSIBLE UNDERSENSING. 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 17327788 ↗
• InjuryApr 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS BACTEREMIA. THE INFECTION DID NOT RESOLVE WITH ANTIBIOTICS AND THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED. A REPLACEMENT LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection

  MAUDE report 16770225 ↗
• InjuryMar 31, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED DUE TO "FAILURE." NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16657553 ↗
• InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING EXTRACARDIAC STIMULATION CAUSED BY THE LEFT VENTRICULAR (LV) LEAD. IT WAS NOTED THAT THE STIMULATION OCCURS IN ALL CONFIGURATIONS. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Overstimulation of Tissue

  MAUDE report 16306576 ↗
• InjurySep 16, 2022Failure to Capture; High Capture Threshold; Failure to Capture; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCE SYNCOPE AND PRE-SYNCOPE CONDITIONS. IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS WITH SUSPECTED CAPTURE ISSUE NOTED. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Presyncope; Syncope/Fainting

  MAUDE report 15438236 ↗
• MalfunctionAug 24, 2022Capturing Problem; Capturing Problem

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF FAST HEART RATE OVER THE LAST FEW WEEKS WITH THREE EVENTS THAT OCCURRED PRESENTLY.  A REVIEW OF THE INTERROGATION REPORT REVEALED THE RIGHT VENTRICULAR (RV) THRESHOLD INCREASING.  IT WAS NOTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS INSERTED INTO THE RV PORT.  THE LV 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 15283841 ↗
• InjuryJul 19, 2022High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH PACING THRESHOLDS. THE LEAD WAS PARTIALLY EXPLANTED WITH THE REMAINING PORTION BEING CAPPED. A NEW LEAD WAS THEN IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15055580 ↗