MULTI-LINK MINI VISION 1007821-18Recalls & reported problems
Abbott Vascular Inc. · MULTI-LINK MINI VISIONCoronary Stent and Stent Delivery System 2.00 mm x 18 mm / Rapid-Exchange · Class 3 · Implant
All models of MULTI-LINK MINI VISION (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08717648049408), received between Mar 6, 2019 and Mar 6, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Advance” (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
- Difficult to Advance1
- Difficult to Remove1
- Improper or Incorrect Procedure or Method1
- Material Deformation1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2019Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Deformation; Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Deformation
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT ANTERIOR DESCENDING ARTERY. AN UNSPECIFIED TURNTRAC GUIDE WIRE (GW) WAS INSERTED AND POSITIONED INTO THE ANATOMY. A 2.0X18MM MINI VISION STENT DELIVERY SYSTEM WAS BACKLOADED ON THE GW AND WHEN ADVANCING (STILL OUTSIDE OF THE ANATOMY) RESISTANCE WAS MET AND THE STENT-BALLOON AREA GOT STUCK ON THE GW. PHYSICIAN ATTEMPTED TO ADVANCE AND WITHDRAW BUT WAS UNABLE TO DO SO. IT WAS THEN NOTED THAT THE STENT-BALLOON AREA HAD A PIECE PROTRUDING WHICH MADE THE PHYSICIAN THINK IT WAS NOT FULLY FLUSHED. THE GUIDE WIRE WAS THEN PULLED WITH MUCH FORCE AS RESISTANCE WAS MET WITH THE ANATOMY AND REMOVED ALTOGETHER AS A SINGLE UNIT ALONG WITH THE SDS. THE PROTRUDING AREA IN THE STENT-BALLOON RETURNED TO ITS NORMAL STATE ONCE TAKEN OFF THE GW. BALLOON ANGIOPLASTY WAS PERFORMED 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 8396034 ↗
Other STENT, CORONARY devices
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- 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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