MULTI-LINK MINI VISION 1007821-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648049378), received between Nov 8, 2016 and Aug 23, 2019 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (3 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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2019Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION AND HEAVY TORTUOSITY. A 2.0 X 08 MM MINI VISION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER FAILED TO CROSS THE LESION DUE TO THE PATIENT ANATOMY. ON REMOVAL OF THE SDS WITHOUT REPORTED FORCE, RESISTANCE WITH THE LESION WAS MET AND THE STENT DISLODGED. MEDICAL INTERVENTION WAS PERFORMED TO REMOVE THE STENT AND A DISSECTION WAS NOTED. AN ADDITIONAL UNSPECIFIED STENT WAS USED TO TREAT THE DISSECTION. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Intimal Dissection

  MAUDE report 8927751 ↗
• InjuryMar 23, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN 2016, A MINI VISION STENT WAS IMPLANTED IN THE CORONARY ARTERY. ON (B)(6) 2018, THE PATIENT WAS HOSPITALIZED FOR CHEST PAIN AND ELEVATED BLOOD SUGARS. ON (B)(6) 2018, AN ANGIOGRAM WAS PERFORMED. THE PREVIOUSLY IMPLANTED STENT WAS TREATED AND ANOTHER STENT WAS IMPLANTED. THE EVENT RESOLVED AND THE PATIENT WAS DISCHARGED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: Angina; High Blood Pressure/ Hypertension; Occlusion

  MAUDE report 7367928 ↗
• MalfunctionJun 14, 2017Detachment Of Device Component; Kinked; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A VERY HEAVILY CALCIFIED LESION IN THE VERY TORTUOUS MID DIAGONAL CORONARY ARTERY. A 2.0X8MM MINI VISION RX BARE METAL STENT (BMS) SYSTEM WAS ADVANCED, BUT FAILED TO CROSS THE LESION DUE TO PATIENT ANATOMY AND, THOUGH NO FORCE WAS APPLIED, THE PROXIMAL SHAFT KINKED. THE STENT SYSTEM WAS WITHDRAWN WITHOUT RESISTANCE, BUT THE SHAFT SEPARATED (SNAPPED INTO TWO PIECES) AT THE KINK AREA DURING WITHDRAWAL. THE LESION WAS THEN DILATED WITH A 2.0X8MM NON-ABBOTT BALLOON FOLLOWED BY ADDITIONAL ATTEMPTS TO CROSS THE LESION WITH OTHER UNSPECIFIED STENT SYSTEM; NO OTHER STENT SYSTEMS WERE ABLE TO CROSS THE LESION DUE TO PATIENT ANATOMY, SO THE PROCEDURE WAS ABORTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6640767 ↗
• InjuryNov 8, 2016Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE LEFT ANTERIOR DESCENDING (LAD), DUE TO THE ACUTE ANGLE OF THE VESSEL, THE 2.0 X 8 MM MINI-VISION STENT BECAME DISLODGED FROM THE BALLOON AND REMAINED ON THE GUIDE WIRE. A 1.5 X 8 MM BALLOON WAS USED TO RETRIEVE AND REMOVE THE STENT FROM THE ANATOMY. THE PROCEDURE WAS COMPLETED USING BALLOON ANGIOPLASTY. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6087404 ↗