MULTI-LINK VISION 1007848-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648050633), received between Apr 13, 2017 and Jul 26, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2022Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION. THE 3.0X18MM RX VISION CORONARY STENT SYSTEM WAS INSERTED BUT FAILED TO CROSS THE LESION. THEREFORE, THE DEVICE WAS REMOVED AND AGAIN INSERTED. THE DEVICE STILL FAILED TO CROSS THE LESION AND WAS REMOVED. PRIOR TO INSERTING THE DEVICE A THIRD TIME, IT WAS OBSERVED THE STENT WAS NO LONGER ON THE CATHETER. IT IS UNKNOWN IF THE STENT CAME OFF WHILE IN THE ANATOMY. ULTRASOUND WAS PERFORMED BUT THE STENT WAS UNABLE TO BE OBSERVED ANYWHERE IN THE ANATOMY. HOWEVER, THE MISSING STENT COULD ALSO NOT BE FOUND OUTSIDE THE ANATOMY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15103404 ↗
• MalfunctionAug 19, 2019Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A 3.00 X 18 MM RX VISION STENT WAS IMPLANTED IN THE DISTAL RIGHT CORONARY ARTERY POST EXPIRATION DATE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8908656 ↗
• MalfunctionMay 2, 2018Difficult To Position; Difficult to Remove

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 95% STENOSED, MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. FOLLOWING PRE-DILATATION, A 3.5X23MM RX VISION STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO THE ANATOMY AND THE PROXIMAL SHAFT SEPARATED. RESISTANCE REMOVING THE SDS WAS FELT. A SECOND 3.5X23MM RX VISION SDS WAS ADVANCED AND THE STENT WAS DEPLOYED WITHOUT ISSUES. UPON REMOVAL, THE SDS BECAME FROZEN ON THE ALLSTAR GUIDE WIRE AND THE PROXIMAL SHAFT SEPARATED. AFTER THE SEPARATION, THE SDS COULD BE REMOVED. A 3.0X18MM RX VISION SDS WAS BEING ADVANCED; HOWEVER, RESISTANCE ADVANCING THE SDS OVER THE GUIDE WIRE OUTSIDE OF THE PATIENT ANATOMY WAS FELT. THE DECISION WAS MADE NOT TO USE IT AND DURING REMOVAL, RESISTANCE WAS ALSO MET WITH THE GUIDE WIRE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW 3.0X18MM RX VISION STENT AND THE SAME ALLSTAR GUIDE WIRE. 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 7480608 ↗
• InjuryApr 13, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN A SEVERELY TORTUOUS AND CALCIFIED LESION LOCATED IN THE POSTERIOR DESCENDING ARTERY. AFTER DEPLOYMENT OF THE 3.0 X 18 MM RX VISION STENT A PERFORATION WAS OBSERVED. A 2.8 X 19 MM GRAFTMASTER STENT DELIVERY SYSTEM WAS ADVANCED FOR TREATMENT; HOWEVER, WOULD NOT CROSS. A BALLOON WAS ADVANCED AND INFLATED SUCCESSFULLY SEALING THE PERFORATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation

  MAUDE report 6490118 ↗