COMPLETE® SE VASCULAR SC680LVRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994726780), received between Jan 5, 2017 and Jan 5, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2017Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A COMPLETE SE STENT TO TREAT A CTO, MODERATELY CALCIFIED AND MILD TORTUOSITY MID SFA LESION. NO DAMAGE NOTED TO DEVICE PACKAGING AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICES FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED PRIOR TO USE, NO ISSUES NOTED. THE DEVICE WAS PREPPED AS PER IFU WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT AFTER STENT DEPLOYMENT RESISTANCE WAS ENCOUNTERED DURING REMOVAL OF THE DELIVERY SYSTEM AND THE TIP OF THE DEVICE DETACHED. THE PHYSICIAN USED ANOTHER STENT TO JAIL THE TIP OF THE COMPLETE SE STENT TO THE VESSEL WALL. NO CLINICAL SEQUELAE REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6224659 ↗