MULTI-LINK VISION 1007848-12Recalls & reported problems
Abbott Vascular Inc. · MULTI-LINK RX VISION Coronary Stent System 3.00 mm x 12 mm · Class 3 · Implant
Data updated Oct 13, 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 08717648050619), received between May 3, 2018 and Jul 20, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (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
Device problems
- Difficult to Remove2
- Break1
- Failure to Advance1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 20, 2021Difficult to Remove; No Apparent Adverse Event; Difficult to Remove; No Apparent Adverse Event
A 3.00X12MM RX VISION BALLOON-EXPANDABLE STENT SYSTEM (BESS) WAS RETURNED IN A BIO BAG WITHOUT ANY INFORMATION. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THE RETURNED DEVICE ANALYSIS IDENTIFIED THAT A BMW UNIVERSAL GUIDE WIRE WAS RETURNED FROZEN IN THE BESS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12198976 ↗MalfunctionMay 3, 2018Break; Difficult to Remove; Failure to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY USING A 3.0 X 12 MM RX VISION STENT DELIVERY SYSTEM (SDS). THE SDS WAS ADVANCING WHEN RESISTANCE WAS MET WITH THE ANATOMY AND IT COULD NOT CROSS THE LESION. THE SDS WAS RETRACTED WHEN IT BECAME CAUGHT WITH THE GUIDE WIRE AND FRACTURED. THE SDS WAS REMOVED WITH THE GUIDE WIRE AS A SINGLE UNIT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN UNSPECIFIED STENT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE OR THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7483867 ↗
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
- Tryton Side Branch Stent T5-3035-151-USTryton Medical, Inc. · Stent, Coronary2 deaths7 reports
- MULTI-LINK VISION 1007850-15Abbott Vascular 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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