Attain Ability™ MRI SureScan™ 419688 (UDI 00643169601772)Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00643169601772), received between Dec 9, 2016 and Sep 15, 2026 — classified as 51 injuries, 23 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (21 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 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026High impedance; Impedance Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50779074 ↗
• InjuryAug 20, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. UPON REVIEW RIGHT VENTRICULAR (RV) LEAD UNDERSENSING WAS NOTED AT TIMES TRIGGERING POSSIBLE INAPPROPRIATE PACING AND THERE WERE POSSIBLE HIGH LEFT VENTRICULAR (LV) LEAD THRESHOLDS. IT WAS ALSO REPORTED THAT RIGHT ATRIAL (RA) LEAD OVERSENSING WAS NOTED ON THE STORED ELECTROGRAMS (EGM) AT TIMES TRIGGERING FALSE CLASSIFICATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES AND THERE WAS A PREVIOUS FAILED ATRIAL LEAD POSITION CHECK. THE RV LEAD, RA LEAD AND LV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 22851853 ↗
• InjuryAug 18, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT DURING THE REPLACEMENT PROCEDURE, "THE LEFT VENTRICULAR (LV) LEAD WAS NOT ABLE TO GET ATTACHED AND THEY PUT A NEW ONE IN". THE PATIENT NOTED THAT THEY HAD "A HEAP OF TROUBLE" AND THAT "THEY GAVE" THE PATIENT A BLOOD CLOT. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22834782 ↗
• MalfunctionMar 4, 2025Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD HAD BEEN DISLODGED FOR YEARS. IT WAS ALSO NOTED THAT THE ATRIAL LEAD TRIGGERED A HIGH PACING IMPEDANCE WARNING. THE RA LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD BEEN PROGRAMMED OFF DUE TO A HISTORY OF NON-CAPTURE. THE LV LEAD REMAINS IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21518609 ↗
• MalfunctionDec 4, 2024Under-Sensing; Capturing Problem; High Capture Threshold; Under-Sensing; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING THAT RESULTED IN FALSE TERMINATION OF ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EPISODES. IT WAS NOTED THAT ELECTROCARDIOGRAM (ECG) DISPLAYED NUMEROUS PREMATURE VENTRICULAR CONTRACTIONS (PVC). THE LEFT VENTRICULAR (LV) LEAD EXHIBITED INCREASING AND HIGH THRESHOLDS. THE 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 20848282 ↗
• MalfunctionJul 10, 2024Impedance Problem; Impedance Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRIGGERED AN ALERT FOR AN OUT OF RANGE (OOR) 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 19708308 ↗
• MalfunctionJun 11, 2024High impedance; High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A RV AND SUPERIOR VENA CAVA (SVC) DEFIBRILLATION LEAD IMPEDANCE WARNING DUE TO HIGH AND UNDEFINED IMPEDANCE MEASUREMENTS. IT WAS NOTED THAT THE RV LEAD HAD A HIGH AND UNDEFINED PACING IMPEDANCE MEASUREMENTS. IT WAS ALSO NOTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD A HIGH AND UNDEFINED IMPEDANCE MEASUREMENT. 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 19515196 ↗
• InjuryMay 22, 2024Adverse 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) WAS EXPLANTED DUE TO INFECTION WITH NOTED FEVER, AND RIGHT VENTRICULAR (RV) LEAD VEGETATION.  THE ORGANISM WAS IDENTIFIED AS POSSIBLY METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS.  A TEMPORARY PACING SYSTEM WAS IMPLANTED.  A FEW DAYS LATER THE TEMPORARY PACING SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG).   NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Drug Resistant Bacterial Infection; Fever; Unspecified Infection

  MAUDE report 19371041 ↗
• InjuryMay 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 SYSTEMIC INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM WAS EXPLANTED AND REPLACED SIX DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 19254378 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO HEART FAILURE WITH A SEPTIC BLOOD INFECTION. THE SOURCE OF THE INFECTION WAS BACTERIAL ENDOCARDITIS. THE SEPSIS WAS TREATED WITH SIX WEEKS OF ANTIBIOTICS. AT THE TIME OF ADMISSION, A DIALYSIS PORT WAS PLACED THROUGH THE SAME VEIN THE LEADS WERE PLACED IN ¿ THE RIGHT SUBCLAVIAN VEIN. THE PHYSICIAN BELIEVED THIS DAMAGED THE RIGHT ATRIAL (RA) LEAD, CAUSING OVERSENSING AND UNDERSENSING. SMALL P WAVES OR NOISE CAUSED THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TO NOT PROPERLY PACE AND A LOSS OF CRT PACING OCCURRED RESULTING IN BRADYCARDIA. THIS FURTHER LEAD TO HEART FAILURE, FLUID OVERLOAD, AND AN IRREGULAR HEART RHYTHM RESULTING IN SHORT-LONG-SHORT EPISODES THAT WERE PROARRHYTHMIC. THE PATIENT STOPPED THEIR ANTIARRHYTHMIC AND HIGH BLOOD PRESSURE MEDICATIONS, AND THEIR SODIUM AND POTASSIUM LEVELS WERE OUT OF RANGE, THUS, MAKING PRO-ARRYTHMIA MORE LIKELY. APPROXIMATELY FOUR WEEKS AFTER THE HOSPITAL ADMISSION, THE RA LEAD WAS REPROGRAMMED LEADING TO ONE HUNDRED PERCENT CRT PACING. IT WAS FURTHER REPORTED THAT BOTH THE ATRIAL AND RIGHT VENTRICULAR (RV) LEADS HAD VEGETATION. THE DEVICE, THE AT RIAL, RV AND

  Patient problems: Endocarditis; Sepsis

  MAUDE report 18978233 ↗
• InjuryNov 29, 2023Adverse 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 WITH PURULENT DISCHARGE AND PUS. 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 18231176 ↗
• InjuryAug 7, 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 A POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17474267 ↗
• MalfunctionJun 30, 2023High Capture Threshold; High Capture Threshold

  IT WAS ALSO REPORTED THAT THE LV LEAD EXHIBITED A SUDDEN RISE IN THRESHOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17236601 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SORENESS IN THE POCKET AND A SUSPECTED INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. A TEMPORARY PACEMAKER WAS USED UNTIL A NEW CRT-D, RIGHT ATRIAL (RA) LEAD, AND RIGHT VENTRICULAR (RV) LEAD WAS IMPLANTED 13 DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 16103192 ↗
• InjuryDec 14, 2022Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING THE GENERATOR CHANGEOUT PROCEDURE, THE ATTEMPT TO PROPHYLACTICALLY REMOVE THE RIGHT VENTRICULAR (RV) LEAD RESULTED IN PLACEMENT DIFFICULTY WITH THE LEFT VENTRICULAR (LV) AND RIGHT ATRIAL (RA) LEADS. WHILE ATTEMPTING TO EXPLANT THE RV LEAD, THE PHYSICIAN UNINTENTIONALLY PULLED OUT THE LV AND RA LEADS. A NEW SYSTEM WAS SUBSEQUENTLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15977554 ↗
• InjuryDec 9, 2022Capturing Problem; Unstable Capture Threshold; Capturing Problem; Unstable Capture Threshold

  IT WAS REPORTED THAT THE PATIENT COMPLAINT OF SYNCOPE TWO TIMES IN THE PAST FEW MONTHS WHILE LAYING DOWN. THE PHYSICIAN SUSPECTED PATIENT WAS HAVING VERTIGO AND THE PATIENT ATTENDED PHYSICAL THERAPY WITH QUESTIONABLE RESULTS. THE RIGHT VENTRICULAR (RV) LEAD IS PROGRAMMED RV SUBTHRESHOLD SINCE SHORTLY AFTER IMPLANT DUE TO HIGH THRESHOLDS, AND SOMETIMES NO CAPTURE AT MAXIMUM OUTPUT. THE LEFT VENTRICULAR FEATURE THAT MONITORS AND CAPTURES THE PACING AMPLITUDE THRESHOLD AND ADJUSTS LV OUTPUTS, TREND DATA SHOW A BASELINE OF VARIABLE THRESHOLDS BUT MORE VARIATION IN THE PAST FEW MONTHS. THE LV LEAD WAS TESTED BUT THERE WAS A 1 VOLT DIFFERENCE IN THRESHOLD WHEN PATIENT WAS LAYING ON THE LEFT SIDE VERSUS THE RIDE SIDE. THE LEFT VENTRICULAR OUTPUT MONITOR AND CAPTURE FEATURE WAS PROGRAMMED TO MONITOR AND THRESHOLDS RE-PROGRAMMED. A REVIEW OF THE DEVICE DATA DID NOT REVEAL A LEAD INTEGRITY ISSUE, INCLUDING THE POSITIONAL THRESHOLD CHANGES. THE LV LEAD REMAINS IN USE. SUBSEQUENTLY, THE RV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Syncope/Fainting

  MAUDE report 15955070 ↗
• MalfunctionFeb 4, 2022Capturing Problem; High Capture Threshold; Capturing Problem; High Capture Threshold

  IT WAS REPORTED THAT LEFT VENTRICULAR (LV) LEAD EXHIBITED A RECENT JUMP IN LV THRESHOLD. THE LONGEVITY OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAS DECREASED DUE TO THE INCREASE IN LV OUTPUTS AND HIGH THRESHOLD. THE LV LEAD AND THE DEVICE 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 13450828 ↗
• InjuryNov 1, 2021Intermittent Capture; Failure to Capture; Intermittent Capture; Failure to Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD NON CAPTURE AND WAS UNABLE TO CAPTURE CONSISTENTLY. 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 12728850 ↗
• InjuryDec 29, 2020High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THERE WAS HIGH THRESHOLD ON THE LEFT VENTRICULAR (LV) LEAD. THE LEAD WAS CAPPED AND REPLACED WITH AN EPICARDIAL LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11089459 ↗
• MalfunctionOct 6, 2020Failure to Capture; Unstable Capture Threshold; Failure to Capture; Unstable Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED VARIABLE THRESHOLDS AND SUSPECTED LOSS OF CAPTURE. THE LV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10634445 ↗
• InjuryFeb 26, 2020High Capture Threshold; High Capture Threshold

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9759135 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TEN DAYS FOLLOWING IMPLANT, THE PATIENT EXPERIENCED STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. THE PHYSICIAN REPROGRAMMED THE LV PACING OUTPUT. APPROXIMATELY TWO YEARS LATER, THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION AND THE LV LEAD PACING CONFIGURATION WAS REPROGRAMMED. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Muscle Stimulation

  MAUDE report 9724424 ↗
• InjuryFeb 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 9688907 ↗
• MalfunctionDec 4, 2019High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THERE WAS A HIGH THRESHOLD ALERT ON THE LEFT VENTRICULAR (LV) LEAD. IT WAS ALSO NOTED THAT THERE WAS A RECENT INCREASE IN RIGHT VENTRICULAR (RV) LEAD THRESHOLD. THE 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 9412627 ↗
• InjuryNov 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Muscle Stimulation

  MAUDE report 9334405 ↗