MULTI-LINK VISION 1007849-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648050725), received between May 2, 2018 and Mar 22, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 22, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT THE 3.5X23 MM VISION STENT WAS NOT IN THE BOX. THERE WAS NO REPORTED DEVICE USE OR PATIENT INVOLVEMENT. TWO 3.0X23 MM VISION STENTS WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11544532 ↗
• MalfunctionMay 2, 2018Detachment Of Device Component; 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 7480614 ↗
• MalfunctionMay 2, 2018Detachment Of Device Component; Difficult to Remove; Failure to Advance

  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 7480585 ↗