MULTI-LINK VISION 1007850-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648050770), received between Feb 22, 2018 and Feb 7, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Collapse” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2019Inflation Problem; Difficult to Advance; Inflation Problem; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN A MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY. PRE-DILATATION WAS PERFORMED WITH A CUTTING BALLOON CATHETER AND A GUIDELINER WAS USED. A 4.0 X 12 MM VISION STENT DELIVERY SYSTEM WAS USED AND MET INITIAL RESISTANCE WITH THE ANATOMY. THE STENT DELIVERY BALLOON WAS INFLATED TO A NOMINAL PRESSURE OF 9 ATMOSPHERES AND DEFLATED WITHOUT ANY ISSUES. HOWEVER, THE STENT WAS STILL ON THE BALLOON WHEN THE DEVICE WAS REMOVED FROM THE ANATOMY. THERE WAS A WAIST IN THE STENT DELIVERY BALLOON. THEREFORE, A 4.0 X 18 MM VISION STENT WAS IMPLANTED TO SUCCESSFULLY 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 8317650 ↗
• MalfunctionJun 25, 2018Detachment Of Device Component

  IT WAS REPORTED THAT DURING ADVANCEMENT OF THE 4.0X12 MM RX VISION STENT DELIVERY SYSTEM (SDS) THE HYPOTUBE FRACTURED (SEPARATED) OUTSIDE THE ANATOMY. THE SDS WAS REPLACED WITH ANOTHER SAME SIZE RX VISION. 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 7636079 ↗
• MalfunctionFeb 22, 2018Collapse; Failure to Advance; Torn Material

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). SEVERAL ATTEMPTS WERE MADE TO ADVANCE THE 4.0X12 RX VISION STENT DELIVERY SYSTEM (SDS); HOWEVER THE SDS FAILED TO CROSS DUE TO THE ANATOMY AND THE TIP BECAME FLARED. ANOTHER SMALLER SIZE VISION SDS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS NOTED A PIECE/STRIP OF THE TIP WAS TORN. NONE OF THE TIP WAS MISSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7289747 ↗