MULTI-LINK VISION 1007849-08Recalls & reported problems
Abbott Vascular Inc. · MULTI-LINK RX VISION Coronary Stent System 3.50 mm x 8 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648050688), received between Sep 22, 2020 and Sep 22, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Failure to Advance1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 22, 2020Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE LEFT CORONARY CIRCUMFLEX (LCX). BEFORE THE PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD PREVIOUSLY UNDERGONE A PROCEDURE IN THE SAME REGION. A 3.50 X 08 MM RX VISION STENT DELIVERY SYSTEM (SDS) WAS PREPPED PER THE INSTRUCTIONS FOR USE AND THE STENT WAS CONFIRMED TO BE ON THE BALLOON PRIOR TO INSERTING THE SDS INTO THE PATIENT ANATOMY. THE SDS WAS ADVANCED TO THE TARGET LESION; HOWEVER, THE SDS FAILED TO CROSS THE LESION. THE SDS WAS REMOVED AND IT WAS NOTED THAT THE STENT WAS DISLODGED FROM THE BALLOON. THE STENT COULD NOT BE SEEN THROUGH ECHOCARDIOGRAPHY; THEREFORE, A NEW 3.0 X 08MM UNSPECIFIED STENT WAS USED AND SUCCESSFULLY IMPLANTED TO THE TARGET LESION. THEN, AN UNSPECIFIED BALLOON WAS INSERTED AND INFLATED AND DRAGGED UP THE GUIDE WIRE IN AN ATTEMPT TO RETRIEVE THE DISLODGED STENT; HOWEVER, THE STENT WAS NOT RETRIEVED. A CT SCAN WAS PERFORMED BUT THE STENT COULD NOT BE SEEN IN THE ANATOMY. THE PROCEDURE ENDED AT THIS POINT. NO ADDITIONAL TREATMENT WAS PERFORMED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 10567751 ↗
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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