MULTI-LINK MINI VISION 1007821-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717648049415), received between Jun 2, 2017 and Jul 25, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT BEFORE USE, THE STENT OF A 2.0 X 23 MM MINI VISION STENT DELIVERY SYSTEM WAS FOUND DISLODGED INSIDE THE PROTECTIVE SHEATH. ANOTHER 2.0 X 23 MM MINI VISION STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 8827479 ↗
• MalfunctionSep 29, 2017Material Rupture; Physical Resistance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 2.0X23 MINI VISION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE BALLOON APPEARED TO BE RUPTURED DURING ATTEMPTED INITIAL INFLATION. THE DEVICE WAS WITHDRAWN WITH NO ISSUE. THE 2.0X15MM MINI VISION SDS WAS ADVANCED HOWEVER THE STENT STRUTS WERE NOTED TO BE FLARED. THE DEVICE WAS REMOVED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER MINI VISION SDS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6903898 ↗
• MalfunctionJun 2, 2017Difficult to Remove; Failure to Advance; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). A NON-ABBOTT STENT WAS DEPLOYED SUCCESSFULLY IN THE PROXIMAL LAD. AN ATTEMPT WAS MADE TO CROSS WITH THE 2.0 X 23 MM MINI VISION SDS AND DURING THE ATTEMPT TO CROSS THROUGH THE NON-ABBOTT STENT, THE MINI VISION STENT BECAME CAUGHT ON THE DEPLOYED NON-ABBOTT STENT. THE DEVICES WERE REMOVED FROM THE PATIENT AS ONE UNIT AND AFTER REMOVAL IT WAS OBSERVED THAT THE NON-ABBOTT STENT WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE NOTED; THEREFORE, THE PROCEDURE CONTINUED ON WITH THE SUCCESSFUL DEPLOYMENT OF NON-ABBOTT AND ABBOTT STENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6609287 ↗