Acculink™ 1011342-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648076336), received between Dec 19, 2025 and Dec 19, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (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.

• MalfunctionDec 19, 2025Mechanical Jam; Activation Failure; Mechanical Jam; Activation Failure

  FOR REPORTING PURPOSES, THE DATE OF EVENT/PROCEDURE IS ESTIMATED AS (B)(6) 2025, AS IT IS THE FIRST DATE OF THE MONTH OF THE AV ALERT DATE. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. PRE-DILATATION WAS PERFORMED WITH A 4.0 MM BALLOON. THE ACCULINK SELF EXPANDING STENT SYSTEM (SESS) WAS ADVANCED TO THE LESION AND DEPLOYMENT WAS ATTEMPTED. THE LEVER WAS STIFF BUT IT WAS THOUGHT THAT THE STENT WAS DEPLOYED. WHEN THE DELIVERY SYSTEM WAS REMOVED, THE STENT WAS UNABLE TO BE FOUND ON THE DELIVERY SYSTEM OR IN THE PATIENT. THE DEVICE WAS CUT OPEN AND THE STENT WAS FOUND INSIDE THE SYSTEM. ANOTHER SAME SIZE ACCULINK SESS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS A SMALL DELAY IN THE PROCEDURE BUT NO HARM TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851432 ↗