Acculink™ 1011342-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648076343), received between Dec 7, 2016 and Oct 9, 2019 — classified as 2 malfunctions.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2019Difficult to Remove; Device Dislodged or Dislocated; Mechanical Jam; Activation Failure; Difficult to Remove; Device Dislodged or Dislocated; Mechanical Jam; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN INTERNAL CAROTID ARTERY. AN ACCULINK WAS ADVANCED TO THE LESION WITH NO RESISTANCE NOTED AND DEPLOYMENT WAS ACTIVATED. HOWEVER, RESISTANCE WAS NOTED WITH THE THUMBSLIDE ALTHOUGH THE STENT WAS ALREADY A LITTLE OUT OF THE SHEATH (PARTIALLY DEPLOYED). THE PHYSICIAN STOPPED AND DECIDED TO REMOVE THE DEVICE. SOME RESISTANCE WAS MET WITH THE ANATOMY DURING REMOVAL. ONCE REMOVED OUTSIDE OF THE ANATOMY, IT WAS NOTED THAT THE STENT CAME OFF COMPLETELY. IT DID NOT REMAIN IN THE ANATOMY. A SECOND STENT WAS DEPLOYED WITHOUT ISSUE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9173205 ↗
• MalfunctionDec 7, 2016Premature Activation; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DEPLOYMENT OF THE ACCULINK STENT WAS INITIATED AT THE LESION IN THE RIGHT COMMON FEMORAL ARTERY; HOWEVER, THE STENT WAS NOT DELIVERED TO THE LESION. THE ANATOMY WAS CHECKED AND THE STENT WAS NOT FOUND IN THE PATIENT. THE STENT DELIVERY SYSTEM WAS REMOVED AND IT WAS SUSPECTED THAT THE STENT REMAINED IN THE DELIVERY SHEATH. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6153116 ↗