MULTI-LINK VISION 1007849-28Recalls & reported problems
Abbott Vascular Inc. · MULTI-LINK RX VISION Coronary Stent System 3.50 mm x 28 mm · Class 3 · Implant
All models of MULTI-LINK VISION (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648050732), received between Dec 20, 2016 and Dec 10, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment Of Device Component” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Detachment Of Device Component1
- Device Dislodged or Dislocated1
- Failure to Advance1
Patient problems
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
DURING PREPARATION OF A 3.50X28MM RX VISION BALLOON EXPANDABLE STENT THE STENT CAME OFF WHEN THE STYLET WAS REMOVED. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 10983962 ↗MalfunctionDec 20, 2016Detachment Of Device Component; Failure to Advance
IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT A VERY HEAVILY CALCIFIED LESION IN A NON-TORTUOUS SAPHENOUS VEIN GRAFT (SVG) TO THE CIRCUMFLEX (CX) CORONARY ARTERY, AN ATTEMPT TO CROSS WAS MADE WITH A 3.5X28 RX VISION BARE METAL STENT (BMS) SYSTEM, BUT THIS DEVICE FAILED TO CROSS DUE TO PATIENT ANATOMY AND THE PROXIMAL SHAFT SEPARATED INTO TWO PIECES (APPROXIMATELY 10CM DISTAL TO THE STRAIN RELIEF). THE DISTAL PORTION WAS ABLE TO SIMPLY BE WITHDRAWN FROM THE ANATOMY WITHOUT DIFFICULTY. AN ATTEMPT TO CROSS WAS THEN MADE WITH A 5.0X20 NC TREK RX BALLOON DILATATION CATHETER (BDC), BUT THIS DEVICE ALSO FAILED TO CROSS DUE TO PATIENT ANATOMY AND THE SHAFT BECAME BENT (KINKED) AND WAS WITHDRAWN. A 4.0X12 NON-ABBOTT STENT WAS ABLE TO CROSS AND TREAT THE LESION SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6192090 ↗
Other STENT, CORONARY devices
- WALLSTENT® Endoprosthesis H965403130Boston Scientific Corporation · STENT, CORONARY35 reports
- WALLSTENT® Endoprosthesis H965402130Boston Scientific Corporation · STENT, CORONARY23 reports
- Tryton Side Branch Stent T5-2530-191-USTryton Medical, Inc. · Stent, Coronary1 death22 reports
- WALLSTENT® Endoprosthesis H965403330Boston Scientific Corporation · STENT, CORONARY21 reports
- WALLSTENT® Endoprosthesis H965403320Boston Scientific Corporation · STENT, CORONARY10 reports
- WALLSTENT® Endoprosthesis H965403120Boston Scientific Corporation · STENT, CORONARY9 reports
- PALMAZ Balloon Expandable Stent P308Cordis US Corp. · STENT, CORONARY7 reports
- Cobra PzF 170-03-35024Celonova Biosciences, Inc. · Stent, Coronary7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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