MULTI-LINK VISION 1007850-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08717648050787), received between Sep 29, 2016 and Mar 30, 2020 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, A 4.0X15MM RX VISION WAS SUCCESSFULLY REMOVED FROM THE HOOP COIL; HOWEVER, WHEN THE PROTECTIVE SHEATH WAS REMOVED FROM THE BALLOON, THE STENT DISLODGED AND REMAINED INSIDE THE SHEATH. THERE WAS NO DIFFICULTY REMOVING THE SHEATH AND THE DEVICE WAS NOT USED IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED DEVICE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9897613 ↗
• MalfunctionAug 2, 2019Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION WHEN PULLING THE STYLET FROM THE END OF THE 4.0 X 15 RX VISION STENT DELIVERY SYSTEM, SLIGHT RESISTANCE WAS MET AND THE STENT BECAME DISLODGED, STILL REMAINING ON THE STYLET. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT INVOLVEMENT. AFTERWARDS THE PHYSICIAN MANIPULATED AND INFLATED THE DEVICE ON THE TABLE FOR TROUBLESHOOTING PURPOSES. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8857678 ↗
• MalfunctionOct 15, 2018Material Separation; Failure to Advance; Material Separation; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE CIRCUMFLEX (CX). THE 4.0X15MM RX VISION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER FAILED TO CROSS THE LESION. THE HYPOTUBE SEPARATED DURING ADVANCEMENT. AS THE SEPARATION WAS OUTSIDE THE ANATOMY, THE DEVICE WAS SIMPLY REMOVED WITHOUT RESISTANCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7965413 ↗
• MalfunctionOct 9, 2018Break

  DURING ADVANCEMENT OF THE STENT, THE SHAFT OF THE STENT BROKE OUTSIDE OF THE BODY. THE STENT WAS PULLED OUT AND WAS NOT DELIVERED. A NEW STENT WAS PULLED AND PLACED WITHOUT DIFFICULTY. MANUFACTURER RESPONSE FOR CORONARY STENT, MULTI-LINK VISION (PER SITE REPORTER). UNKNOWN AT THIS TIME. RETURNING IT TO MANUFACTURER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7946303 ↗
• MalfunctionMay 4, 2017Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. A 4.0 X 15 MM VISION STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION AND INFLATED; HOWEVER, THE STENT COULD NOT BE SEEN UNDER ANGIOGRAPHY. THE STENT WAS FOUND ON THE PREP TABLE STILL TIGHTLY CRIMPED. A 4.0 X 18 MM VISION STENT WAS DEPLOYED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6544579 ↗
• MalfunctionMar 13, 2017Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY. A 4.0 X 15 MM VISION STENT DELIVERY SYSTEM WAS PREPPED; HOWEVER, PRIOR TO ENTERING THE PATIENT, THE PHYSICIAN THOUGHT THERE WAS NO STENT ON THE BALLOON. THE TECHNICIAN SAID THERE WAS, SO THE PHYSICIAN ADVANCED THE VISION TO THE LESION AND INFLATED THE BALLOON. ANGIOGRAPHY REVEALED THERE WAS NO STENT IN THE LESION. THERE WAS A SEARCH MADE OF THE LAB AND THE PACKAGING TO SEE IF THE STENT HAD DISLODGED INSIDE THE PACKAGING, BUT IT COULD NOT BE FOUND. THE PROTECTIVE SHEATH WAS UNABLE TO BE SEARCHED AND IT HAD ALREADY BEEN DISCARDED. ANOTHER VISION STENT WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6401110 ↗
• MalfunctionSep 29, 2016Component Missing

  IT WAS REPORTED DURING UNPACKING OF THE VISION STENT DELIVERY SYSTEM (SDS) THERE WAS ONLY THE BALLOON AND STYLET, THE PROTECTIVE SHEATH AND STENT WERE MISSING. THE BALLOON HAD CRIMP MARKS BETWEEN THE MARKERS AS STENT HAD BEEN PLACED. THERE HAD BEEN NO RESISTANCE NOTED DURING REMOVAL OF THE SDS FROM THE HOOP. THE HOOP WAS INSPECTED FOR THE PROTECTIVE SHEATH AND STENT BUT WERE NOT FOUND. THE SDS WAS NOT USED AND A NEW VISION SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 5988860 ↗