MULTI-LINK MINI VISION 1007822-15Recalls & reported problems
Abbott Vascular Inc. · MULTI-LINK MINI VISION Coronary Stent and Stent Delivery System 2.25 mm x 15 mm / Rapid-Exchange · Class 3 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648049453), received between May 25, 2017 and Jan 28, 2019 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated2
- Failure to Advance1
Patient problems
- Foreign Body In Patient1
- 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.
MalfunctionJan 28, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CONCENTRIC MID CIRCUMFLEX ARTERY THAT DID NOT HAVE ANY TORTUOSITY AND WAS 100% STENOSED. BEFORE USE, A 2.25 X 15 MM MINI VISION STENT DISLODGED FROM THE STENT DELIVERY BALLOON WHEN THE STYLET WAS REMOVED. THEREFORE, A 2.25 X 18 MM MINI VISION STENT WAS IMPLANTED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 8281603 ↗InjuryMay 25, 2017Failure to Advance; Device Dislodged or Dislocated
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE HEAVILY CALCIFIED, 90% STENOSED, MID RIGHT CORONARY ARTERY. AFTER PLACEMENT OF A JR4 6FR GUIDING CATHETER, THE DECISION WAS MADE TO EXCHANGE IT FOR AN AR1 GUIDE CATHETER. A 2.0 MM TREK BALLOON WAS USED FOR PREDILATATION. THE 2.75 X 12 MM RX VISION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED IN AN ATTEMPT TO CROSS THE LESION; HOWEVER, IT FAILED TO CROSS. ADDITIONAL PRE-DILATATION WAS PERFORMED WITH AN NC TREK BALLOON, FOLLOWED BY THE ADVANCEMENT OF A 6FR GUIDELINER. AN ATTEMPT WAS MADE TO CROSS WITH A 2.25 X 15 MM MINI VISION SDS; HOWEVER, DURING POSITIONING ATTEMPTS, THE STENT IMPLANT DISLODGED FROM THE BALLOON INTO THE ANATOMY. NO ATTEMPTS WERE MADE TO RETRIEVE THE STENT IMPLANT WHICH REMAINS IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 6590477 ↗
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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