Attain Ability™ Straight MRI SureScan™ 439678 (UDI 00643169601802)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169601802), received between Apr 6, 2017 and Aug 18, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “High Capture Threshold” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Intermittent Capture; Intermittent Capture

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED INTERMITTENT LOSS OF CAPTURE. THE LEAD REMAINS IN USE. NO PATIENT COMP LICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22835292 ↗
• MalfunctionJul 13, 2020High Capture Threshold; High Capture Threshold

  IT WAS REPORTED THAT THERE WAS A 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 Consequences Or Impact To Patient

  MAUDE report 10264925 ↗
• MalfunctionApr 25, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE, THE LEFT VENTRICULAR LEAD DISLODGED. THE LEAD WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7459996 ↗
• InjuryAug 9, 2017Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT WAS SYMPTOMATIC AND WAS SEEN IN THE CLINIC. INTERROGATION OF THE DEVICE FOUND ANODAL STIMULATION. PROGRAMMING CHANGES WERE MADE AND THE LEFT VENTRICULAR LEAD REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE PRODUCT SURVEILLANCE REGISTRY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 6783330 ↗
• MalfunctionJun 8, 2017Failure to Capture; High Capture Threshold; Unstable Capture Threshold; Failure to Capture; High Capture Threshold; Unstable Capture Threshold

  IT WAS REPORTED THAT THE LEFT VENTRICULAR LEAD HAD HIGH THRESHOLD. THE LEAD WAS EXPLANTED AND DURING THE REPLACEMENT PROCEDURE, TWO LEADS WERE ATTEMPTED AND NOT USED. BOTH HAD NO CAPTURE, AND HIGH AND UNSTABLE THRESHOLD. ANOTHER LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6627631 ↗
• MalfunctionApr 6, 2017Fracture; High Capture Threshold; Fracture; High Capture Threshold

  IT WAS REPORTED THE LEFT VENTRICULAR (LV) LEAD WAS FRACTURED WHILE TYING IT DOWN AT THE SUTURE COLLAR. IT WAS FURTHER REPORTED THE CAPTURED THRESHOLD INCREASED AFTER TYING IT DOWN. THE LEAD WAS REMOVED 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 6469625 ↗