MULTI-LINK VISION 1007850-28Recalls & reported problems
Abbott Vascular Inc. · MULTI-LINK RX VISION Coronary Stent System 4.00 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
- 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 08717648050817), received between Jun 6, 2017 and Jun 6, 2017 — classified as 1 malfunction.
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
- Improper or Incorrect Procedure or Method1
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.
MalfunctionJun 6, 2017Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PROCEDURE WAS TO LESION IN THE SAPHENOUS VEIN GRAFT TO THE OBTUSE MARGINAL. WHEN THE RX VISION 4.0 X 28 MM CORONARY STENT SYSTEM WAS ADVANCED IN THE PATIENT, IT WAS NOTICED UNDER FLUOROSCOPY THAT THE STENT HAD COME OFF THE BALLOON. THE STENT COULD NOT BE VISUALIZED IN THE PATIENT AND WAS LATER FOUND IN THE TRASH. IT WAS DETERMINED THAT THE STENT HAD COME OFF THE BALLOON WHEN THE PROTECTIVE SHEATH WAS REMOVED. THE STENT SYSTEM WAS NOT INSPECTED PRIOR TO ENTERING THE PATIENT TO ENSURE THE STENT WAS ON THE BALLOON. THE PROCEDURE WAS COMPLETED BY DEPLOYING THREE ADDITIONAL RX VISION STENTS. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6615272 ↗
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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