MULTI-LINK VISION 1007850-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648050794), received between Nov 8, 2016 and Sep 25, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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.

• MalfunctionSep 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING CORONARY ARTERY (MLAD). DURING ADVANCEMENT OF THE RX VISION STENT DELIVERY SYSTEM (SDS), THE STENT DISLODGED PRIOR TO ENTERING THE TUOHY VALVE; HOWEVER, THIS WAS NOT NOTED UNTIL AFTER THE BALLOON WAS INFLATED AT THE LESION. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER RX VISION WAS SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10589731 ↗
• MalfunctionNov 8, 2016Difficult to Remove; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS A SAPHENOUS VEIN GRAFT TO THE DIAGONAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. AN RX VISION 4 X 18 MM CORONARY STENT SYSTEM WAS PREPPED AND PLACED INSIDE A GRAFT AND WAS POST-DILATED. AFTER INTRAVASCULAR ULTRASOUND, THE STENT COULD NOT BE SEEN. IT WAS DISCOVERED THAT THE STENT HAD COME OFF THE BALLOON AND WAS STUCK BETWEEN THE STYLET AND PROTECTIVE SHEATH COVERING. THIS HAPPENED DURING PREPARATION WITHOUT REALIZING IT HAD COME OFF. IT WAS REPORTED THAT FORCE WAS APPLIED DURING REMOVAL OF THE PROTECTIVE SHEATH. ANOTHER SAME SIZE STENT WAS USED TO TREAT THE VESSEL. 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 6085463 ↗