MULTI-LINK MINI VISION 1007823-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648049507), received between Apr 27, 2017 and Jan 22, 2019 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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. 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.

• MalfunctionJan 22, 2019Material Separation; Failure to Advance; Deformation Due to Compressive Stress; Material Separation; Failure to Advance; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY TORTUOUS AND HEAVILY CALCIFIED LESION IN THE MID TO DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE TARGET LESION WAS PRE-DILATED WITH AN UNSPECIFIED DEVICE. THE 2.5X12MM MINI VISION RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH ANATOMICAL RESISTANCE, AND THE BDC SHAFT KINKED AND SUBSEQUENTLY BROKE INTO TWO SEPARATE PIECES ON THE PORTION JUST INSIDE THE GUIDING CATHETER. THE ENTIRE BDC WAS WITHDRAWN FROM THE PATIENT ANATOMY AS A SINGLE UNIT WITH THE GUIDING CATHETER AND GUIDE WIRE, AND IT WAS CONFIRMED THAT NO BDC DEVICE COMPONENTS REMAINED IN THE PATIENT ANATOMY. ANOTHER MINI VISION BDC WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS, AND 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 8268787 ↗
• InjurySep 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT HE HAD A MYOCARDIAL INFARCTION IN THE RIGHT CORONARY ARTERY (RCA) ON (B)(6) 2013. FOUR VISION STENTS WERE IMPLANTED EMERGENTLY AT (B)(6) HOSPITAL, (B)(6) BY DR. (B)(6). A MINI VISION RX 2.25 X 8 MM AND A VISION RX 2.75 X 15 MM WERE IMPLANTED IN THE MID RCA, A MINI VISION RX 2.5 X 15 MM WAS IMPLANTED IN THE PROXIMAL RCA, AND A MINI VISION RX 2.5 X 12 MM WAS IMPLANTED IN THE DISTAL RCA. FOUR YEARS LATER, THE PATIENT WAS RE-ADMITTED ON (B)(6) 2017 WITH LIGHTHEADEDNESS, DIZZINESS, ANGINA AND ANOTHER MYOCARDIAL INFARCTION. THE PATIENT STATED HE WAS TOLD THAT ALL FOUR OF THE PREVIOUSLY PLACED STENTS WERE 100% BLOCKED; ALTHOUGH HE WAS NOT TOLD WHETHER THIS WAS DUE TO THROMBOSIS OR RE-STENOSIS. TWO ADDITIONAL UNKNOWN STENTS WERE EMERGENTLY IMPLANTED AS TREATMENT AT FLORIDA HOSPITAL BY DR. MASSARO. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dizziness; Myocardial Infarction; Occlusion

  MAUDE report 7843593 ↗
• MalfunctionFeb 15, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN AN UNSPECIFIED CORONARY ARTERY. THE 2.5 X 12 MM MINI VISION STENT DELIVERY SYSTEM (SDS) WAS INSERTED THROUGH THE COPILOT BLEEDBACK CONTROL VALVE AND ADVANCED WITHOUT RESISTANCE TO THE TARGET LESION. AT THE TARGET LESION THE STENT COULD NOT BE SEEN; THEREFORE, THE SDS WAS WITHDRAWN FROM THE PATIENT ANATOMY. IT WAS THEN NOTED THAT THE STENT HAD DISLODGED AND WAS INSIDE THE COPILOT. THERE WAS NO RESISTANCE NOTED DURING INSERTION WITH THE COPILOT. A NEW 2.5 X 12 MM MINI VISION WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7274579 ↗
• MalfunctionApr 27, 2017Detachment Of Device Component

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MID LEFT ANTERIOR DESCENDING ARTERY. A 2.5 X 12 MM MINI VISION STENT DELIVERY SYSTEM WAS BEING ADVANCED OVER A BALANCE MIDDLEWEIGHT (BMW) GUIDE WIRE WHEN THE HYPOTUBE SEPARATED OUTSIDE THE ANATOMY. THE DEVICE WAS EASILY REMOVED FROM THE GUIDE WIRE. A NEW MINI VISION STENT WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6528620 ↗