Attain Ability™ MRI SureScan™ 419688 (UDI 00643169860032)Recalls & reported problems

Summary

The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 00643169860032), received between Aug 9, 2017 and Sep 30, 2026 — classified as 105 injuries, 48 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (44 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 153 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 50952367 ↗
• MalfunctionSep 30, 2026Low impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951605 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Medical device site infection

  MAUDE report 50542996 ↗
• MalfunctionAug 21, 2026Capturing Problem; High Capture Threshold

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50374773 ↗
• MalfunctionAug 11, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50213504 ↗
• MalfunctionMay 27, 2026High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND THRESHOLDS GREATER THAN THE PROGRAMMED OUTPUTS. 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 25306323 ↗
• MalfunctionMay 13, 2026Capturing Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD IMPLANTED IN THE RIGHT VENTRICULAR (RV) PORT EXHIBITED INCREASED 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 25166611 ↗
• InjuryMay 4, 2026Device Dislodged or Dislocated

  IT WAS REPORTED BY THE PATIENT FIANCÉE THAT THE LEFT VENTRICULAR (LV) LEAD MOVED AFTER IMPLANT.  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 25068370 ↗
• InjuryApr 9, 2026Under-Sensing

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED NO SENSING. 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 24829241 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 24735351 ↗
• MalfunctionMar 19, 2026Over-Sensing; Pacing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING IN NON-PHYSIOLOGIC INTERVALS WITH POSSIBLE INHIBITION OF PACING. IT WAS NOTED THAT THE PATIENT EXPERIENCED LIGHTHEADEDNESS. THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness

  MAUDE report 24637412 ↗
• MalfunctionMar 16, 2026High 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 24607859 ↗
• InjuryFeb 12, 2026High impedance

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE (OOR) PACING IMPEDANCE. NOISE WAS ALSO OBSERVED ON THE RV LEAD AND A LOW VOLTAGE FRACTURE WAS SUSPECTED. THE RV LEAD WAS EXPLANTED AND REPLACED. ADDITIONALLY, DURING THE RV LEAD REPLACEMENT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE (OOR) PACING IMPEDANCE AND WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324457 ↗
• MalfunctionJan 30, 2026High Capture Threshold

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING ON STORED EPISODES DURING ATRIAL TACHYCARDIA (AT) / ATRIAL FIBRILLATION (AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED 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 24224620 ↗
• InjuryJan 6, 2026Failure to Capture

  IT WAS REPORTED THAT TWO LEFT VENTRICULAR (LV) LEADS EXHIBITED INTERMITTENT CAPTURE AND THE PATIENT EXPERIENCED ASYSTOLE.  IT WAS NOTED THAT ONE OF THE LV LEADS WAS PLACED IN THE CORONARY SINUS OVER THE RIGHT VENTRICLE AND WAS SET TO SUBTHRESHOLD SETTING AND ONE LV LEAD WAS PLACED IN THE CORONARY SINUS FOR LEFT VENTRICLE PACING  BOTH LEFT VENTRICULAR (LV) LEADS WAS EXPLANTED AND REPLACED AND A EPICARDIAL RIGHT VENTRICULAR (RV) LEAD WAS IMPLANTED.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Asystole

  MAUDE report 23985550 ↗
• InjuryNov 21, 2025Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT THERE WAS A POSTITIONING/PLACEMENT ISSUE NOTED WITH THE LEFT VENTRICULAR (LV) LEAD. THE LEAD WAS REVISED AND THE SLACK WAS PULLED BACK AS TO NOT INTERFERE WITH THE TRICUSPID VALVE. 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 23623443 ↗
• InjuryOct 23, 2025Adverse 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 EROSION. THE CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AND LEADS WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Medical device site infection

  MAUDE report 23367666 ↗
• InjurySep 16, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. 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 23066097 ↗
• InjurySep 11, 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 AND REPLACED DUE TO A POCKET INFECTION. A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23028746 ↗
• InjurySep 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A FEW DAYS POST IMPLANT, THE LEFT VENTRICULAR (LV) LEAD WAS EXPLANTED AND REPLACED DUE TO DISLODGEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22987004 ↗
• MalfunctionSep 3, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST IMPLANT, THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS AND HAS CONTINUED TO EXHIBIT 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 22953696 ↗
• InjuryJul 25, 2025High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR SHORTNESS OF BREATH AND PALPITATIONS. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLD AND WAS STATED TO EXHIBIT HISTORICAL INCREASE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Dyspnea

  MAUDE report 22610936 ↗
• InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE DAY POST IMPLANT OF THE LEFT VENTRICULAR (LV) LEAD, THE PATIENT EXPERIENCED INTERMITTENT, POSITIONAL PHRENIC NERVE STIMULATION. THE LEAD WAS EXPLANTED AND AN RIGHT VENTRICULAR (RV) LEAD WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Undesired Nerve Stimulation

  MAUDE report 22502500 ↗
• InjuryApr 30, 2025Failure to Capture; High impedance; Over-Sensing; High Capture Threshold; Failure to Capture; High impedance; Over-Sensing; High Capture Threshold

  IT WAS REPORTED THAT A LOSS OF CAPTURE AND OVERSENSING WAS OBSERVED ON BOTH THE RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD. IT WAS NOTED THAT THE CORONARY SINUS LEAD WAS IN THE RIGHT VENTRICULAR PORT OF THE IMPLANTABLE PULSE GENERATOR (IPG). IT WAS ALSO NOTED THAT THE PATIENT HEART RATE WAS FALLING BELOW THE PROGRAMMED LOWER RATE LIMIT. A RIGHT VENTRICULAR (RV) LEAD BIPOLAR LEAD IMPEDANCE WARNING WAS TRIGGERED DUE TO HIGH AND UNDEFINED IMPEDANCE MEASUREMENTS. IT WAS NOTED THAT THE RV LEAD EXHIBITED HIGH THRESHOLD MEASUREMENTS. THE PATIENT UNDERWENT A LEAD REVISION, AND A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED AND REMAINS IN USE. THE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM ALSO REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 21936403 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY NINE WEEKS POST UPGRADE PROCEDURE DISCOMFORT, REDNESS AND SWELLING WERE NOTED AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED DUE TO INFECTION. IT WAS NOTED THAT THE SOURCE OF THE INFECTION WAS CUTIBACTERIUM ACNE WHICH INFECTED THE DEVICE POCKET SITE AND CELLULITIS WAS NOTED. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REPLACED THREE MONTHS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cellulitis; Discomfort; Erythema; Medical device site infection; Swelling/ Edema

  MAUDE report 21886363 ↗