MULTI-LINK VISION 1007849-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08717648050701), received between Jan 4, 2018 and Feb 6, 2020 — classified as 1 death, 3 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionFeb 6, 2020Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING DEVICE PREPARATION, RESISTANCE WAS MET DURING REMOVAL OF THE PROTECTIVE SHEATH AND ONCE REMOVED, IT WAS NOTED THAT THE STENT WAS DISLODGED. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. ANOTHER VISION STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9679431 ↗
• DeathAug 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN ACUTE MYOCARDIAL INFARCTION. FOLLOWING THE USE OF A NON-ABBOTT HEART PUMP, A 3.50X15 MM RX VISION STENT WAS SUCCESSFULLY DEPLOYED IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. POST DEPLOYMENT OF THE STENT, COMPLETE OCCLUSION OF THE STENT OCCURRED ALMOST IMMEDIATELY. THE PATIENT CODED. DESPITE CHEST COMPRESSIONS BEING PERFORMED, THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Occlusion

  MAUDE report 7824796 ↗
• MalfunctionMay 1, 2018Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Physical Resistance; Torn Material

  IT WAS REPORTED THAT THE 3.5X15 MM VISION STENT DELIVERY SYSTEM (SDS) WAS INSERTED FOR DIRECT STENTING IN THE HEAVILY CALCIFIED, MID RIGHT CORONARY ARTERY (RCA), BUT WAS UNABLE TO ADVANCE. PREDILATATION WAS PERFORMED AND A 6 FRENCH GUIDELINER WAS INSERTED, WHICH ALLOWED THE VISION SDS TO REACH THE VESSEL. THE STENT WAS SUCCESSFULLY DEPLOYED AT RATED BURST PRESSURE. (B)(6) PRESSURE WAS ONLY HELD FOR A FEW SECONDS ON THE SDS WHEN THE PARTIALLY DEFLATED SDS BALLOON WAS RETRACTED FROM THE RCA AND MET RESISTANCE WITH THE GUIDELINER. THE SDS BALLOON BECAME BUNCHED UP AND WAS REMOVED WITH THE GUIDELINER AS A UNIT. AFTER REMOVAL FROM THE ANATOMY, A TEAR WAS THOUGHT TO BE SEEN ON THE SDS BALLOON. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7476920 ↗
• MalfunctionJan 4, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING PREPARATION OF THE 3.5 X 15 MM RX VISION STENT DELIVERY SYSTEM (SDS), WHEN REMOVING THE PROTECTIVE SHEATH, THE STENT IMPLANT DISLODGED FROM THE BALLOON. THERE WAS NO REPORT OF RESISTANCE FELT DURING REMOVAL OF THE SHEATH. THE DEVICE COULD NOT BE USED ON THE PATIENT. A NEW SDS WAS USED TO COMPLETE THE CASE SUCCESSFULLY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 7164988 ↗