MULTI-LINK VISION 1007850-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648050763), received between Sep 1, 2017 and Sep 1, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.

• MalfunctionSep 1, 2017Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE HEAVILY CALCIFIED CIRCUMFLEX (CX) ARTERY. AFTER SUCCESSFUL DEPLOYMENT OF A STENT DISTALLY IN THE CX, A 4.0 X 8 MM MULTI-LINK VISION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO DEPLOY A SECOND STENT PROXIMAL TO THE FIRST STENT. DURING ADVANCEMENT IT WAS OBSERVED THAT SDS WAS HAVING DIFFICULTY CROSSING THE HEAVY CALCIFICATION AND A REVIEW OF ANGIOGRAPHY NOTED THE STENT WAS ALSO OBSERVED TO BE TOO SHORT TO COVER THE REMAINING LESION. THE DECISION WAS MADE TO REMOVE THE SDS AND USE A LONGER 4.0 X 12 MM STENT. AFTER RETRACTION OF THE SDS FROM THE ANATOMY IT WAS OBSERVED THAT THE DISTAL END OF THE STENT WAS FLARED AND THAT THE STENT IMPLANT HAD BEEN PUSHED OFF THE BALLOON ONTO THE SHAFT OF THE DELIVERY SYSTEM. THE 4.0 X 12 MM VISION STENT WAS USED SUCCESSFULLY FOR TREATMENT. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6838033 ↗