MULTI-LINK VISION 1007849-18Recalls & reported problems
Abbott Vascular Inc. · MULTI-LINK RX VISION Coronary Stent System 3.50 mm x 18 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 08717648050718), received between Sep 29, 2017 and Oct 11, 2023 — classified as 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
- Difficult to Remove1
- Failure to Advance1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- 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.
MalfunctionOct 11, 2023Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS LEFT VERTEBRAL ARTERY THAT WAS NOTED TO HAVE IN-STENT RESTENOSIS. THE 3.5X18MM VISION STENT FAILED TO CROSS DUE TO ANATOMY. RESISTANCE WAS FELT WITH THE UNSPECIFIED CATHETER DURING REMOVAL. THE DEVICES HAD TO BE REMOVED AS A SINGLE UNIT. UPON REMOVAL, THE STENT STRUT WAS OBSERVED TO BE FLARED. A NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17913287 ↗MalfunctionSep 29, 2017Device Dislodged or Dislocated
IT WAS REPORTED THAT A 3.5 X 18 MM VISION STENT DISLODGED FROM THE BALLOON AND REMAINED IN THE STYLET WHEN THE STENT DELIVERY SYSTEM WAS REMOVED FROM THE HOOP. THE STENT WAS NOT STUCK IN THE PROTECTIVE SHEATH AND IT REMAINED CRIMPED. THEREFORE, ANOTHER UNSPECIFIED STENT 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.
Patient problems: No Patient Involvement
MAUDE report 6905894 ↗
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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