MULTI-LINK MINI VISION 1007823-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648049514), received between Nov 28, 2016 and Mar 26, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2020Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE CIRCUMFLEX ARTERY THAT WAS MILDLY CALCIFIED AND TORTUOUS. AFTER A FAILED ATTEMPT TO CROSS WITH THE MINI VISION, WHEN THE DELIVERY SYSTEM WAS WITHDRAWN AND ON THE TABLE, THE STENT CAME OFF THE BALLOON. ANOTHER MINI VISION WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED 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 9885714 ↗
• 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. (B)(6). NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina; Dizziness; Myocardial Infarction; Occlusion

  MAUDE report 7843585 ↗
• MalfunctionDec 11, 2017Break

  IT WAS REPORTED THAT THE 2.5X15 MM MINI VISION STENT DELIVERY SYSTEM (SDS) WAS REMOVED FROM THE HOOP WITHOUT RESISTANCE WHEN IT WAS NOTED TO HAVE A BROKEN SHAFT (SEPARATED IN TWO PIECES). THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7106964 ↗
• MalfunctionJul 24, 2017Failure to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN A MID DIAGONAL CORONARY ARTERY. AFTER PERFORMING ATHERECTOMY IN THE LESION, THE LESION WAS PRE-DILATED WITH A 2.0 X 20 MM MINI TREK BALLOON. AN ATTEMPT WAS THEN MADE TO CROSS THE LESION WITH A 2.5 X 15 MM MINI VISION RX BARE METAL STENT (BMS) SYSTEM, WITH NO UNUSUAL FORCE APPLIED, BUT THIS DEVICE FAILED TO CROSS THE LESION. THE MINI VISION RX BMS WAS WITHDRAWN WITHOUT RESISTANCE, HOWEVER, UPON WITHDRAWAL, THE STENT WAS NOTED TO HAVE DISLODGED PROXIMALLY ONTO THE SHAFT AND THE PROXIMAL END OF THE STENT STRUTS APPEARED TO BE MANGLED. THE PATIENT WAS TREATED VIA ADDITIONAL BALLOON DILATATION WITH AN UNSPECIFIED 2.5 X 8 MM BALLOON, FOLLOWED BY DEPLOYMENT OF A 2.5 X 20 MM NON-ABBOTT STENT. 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 6736309 ↗
• MalfunctionNov 28, 2016Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT A VERY FIBROTIC AND CALCIFIED LESION IN THE SAPHENOUS VEIN GRAFT (SVG) TO THE 1ST OBTUSE MARGINAL (OM1) CORONARY ARTERY, A NON-ABBOTT EMBOLIC PROTECTION DEVICE WAS PLACED DISTAL TO THE LESION. PRE-DILATATION WAS THEN PERFORMED WITH AN UNSPECIFIED 2.0MM TREK BALLOON. A 2.5X15 RX MINI VISION BARE METAL STENT (BMS) SYSTEM WAS ADVANCED TO THE LESION, BUT THE RX MINI VISION BMS WAS UNABLE TO CROSS THE LESION DUE TO PATIENT ANATOMY, DESPITE APPLYING FORCE. PRIOR TO WITHDRAWING THE RX MINI VISION (DUE TO FAILURE TO CROSS), THE EMBOLIC PROTECTION DEVICE WAS RETRACTED OVER THE VISION, HOWEVER, WHILE RETRACTING THE EMBOLIC PROTECTION DEVICE OVER THE MINI VISION, THE MINI VISION STENT WAS PULLED PROXIMALLY OFF OF THE VISION DELIVERY SYSTEM (DISLODGED); AS THE STENT WAS LOCATED INSIDE OF THE EMBOLIC PROTECTION NET, ALL DEVICES WERE WITHDRAWN AS A SINGLE UNIT WITHOUT ISSUE. ANOTHER SAME SIZE MINI VISION WAS USED TO COMPLETE THE PROCEDURE. 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 6129768 ↗