MULTI-LINK VISION 1007847-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648050572), received between Apr 13, 2017 and Oct 28, 2019 — classified as 2 malfunctions.

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. How this data works · Data updated Oct 13, 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 28, 2019Difficult to Remove; Material Separation; Difficult to Advance; Difficult to Remove; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. AN UNSPECIFIED GUIDE WIRE WAS ADVANCED TO THE TARGET LESION. THEN A 2.75 X 18 MM VISION STENT DELIVERY SYSTEM (SDS) WAS ADVANCING OVER THE GUIDE WIRE; HOWEVER, RESISTANCE MET WITH THE GUIDE WIRE. THEREFORE, THE SDS RETRACTED BACK WITH RESISTANCE WHEN THE TIP BECAME SEPARATED OUTSIDE THE PATIENT¿S ANATOMY. THE DETACHED TIP AND THE REMAINDER OF THE SDS WAS REMOVED FROM THE GUIDE WIRE. ANOTHER 2.75 X 18 MM VISION SDS WAS ADVANCED WITH THE SAME GUIDE WIRE. THE TARGET LESION WAS SUCCESSFULLY TREATED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9246792 ↗
• MalfunctionApr 13, 2017Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROTECTIVE SHEATH WAS REMOVED FROM THE 2.75 X 18 MM VISION STENT DELIVERY SYSTEM (SDS) WITHOUT ISSUE. THE DEVICE WAS THEN PREPARED FOR USE INSIDE THE ANATOMY. THE SDS WAS ADVANCED TO THE RIGHT CORONARY ARTERY TARGET LESION, BUT THE STENT WAS NOT ON THE SDS. THE STENT WAS FOUND INSIDE THE PROTECTIVE SHEATH. ANOTHER VISION STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6488969 ↗