MULTI-LINK ULTRA 1003382-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08717648035319), received between Jul 19, 2017 and Sep 19, 2019 — classified as 2 injuries, 3 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2019Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE 5X18MM MULTILINK ULTRA STENT WAS DEPLOYED AT 12 ATMOSPHERES. THE STENT BALLOON FACED RESISTANCE DURING REMOVAL WITH THE DEPLOYED STENT DESPITE SEVERAL ATTEMPTS. THE STENT DELIVERY SYSTEM WAS REMOVED WITH FORCE. AN UNSPECIFIED INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS USED AND CONFIRMED THAT THE STENT WAS NOT DAMAGED. THERE WERE NO 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 9090475 ↗
• InjuryAug 23, 2018Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  USER FACILITY MEDWATCH REPORT RECEIVED THAT STATES "STENT CAME OFF THE END OF THE BALLOON AND WIRE AS IT WAS BEING INSERTED IN THE CELIAC. THE CELIAC ARTERY WAS APPROACHED LAST. DESPITE MULTIPLE ATTEMPTS AT ADVANCING THE 7 FRENCH OSCOR CONFORMABLE SHEATH THIS WAS UNSUCCESSFUL IN PROVIDING ENOUGH SUPPORT TO ADVANCE A 5 X 19 MM GORE V BX STENT. WITH REPEAT ATTEMPT USING AN 8.5 FRENCH OSCOR CONFORMABLE SHEATH, WIRE ACCESS TO THE CELIAC ARTERY WAS LOST. " ADDITIONAL INFORMATION RECEIVED: A 4.0 X 15 MM MULTI-LINK VISION BALLOON-EXPANDABLE STENT WAS SUCCESSFULLY IMPLANTED IN THE CELIAC ARTERY. THEN, A 5.0 X 18 MM ULTRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH A 7 FRENCH SHEATH AND INTO THE PROXIMAL CELIAC ARTERY, BUT COULD NOT ADVANCE THROUGH THE PREVIOUSLY IMPLANTED MULTI-LINK VISION SDS IN AN ATTEMPT TO OVERLAP. DURING REMOVAL OF THE ULTRA STENT, THE STENT DISLODGED OFF THE BALLOON AND HALF INTO THE CELIAC ARTERY. THE DELIVERY SYSTEM WAS REMOVED AND A 1.5 MM UNSPECIFIED BALLOON CATHETER WAS ADVANCED TO CAPTURE THE DISLODGED STENT AND PUSH IT FORWARD INTO THE PREVIOUSLY IMPLANTED STENT TO TREAT THE TARGET LESION. POST-DILATATION WAS PERFORMED WITH UNSPECIFIED BALLOON CATHETERS T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7810378 ↗
• MalfunctionJul 6, 2018Detachment of Device or Device Component

  STENT CAME OFF THE END OF THE BALLOON AND WIRE AS IT WAS BEING INSERTED IN THE CELIAC. THE CELIAC ARTERY WAS APPROACHED LAST. DESPITE MULTIPLE ATTEMPTS AT ADVANCING THE 7 FRENCH OSCOR CONFORMABLE SHEATH THIS WAS UNSUCCESSFUL IN PROVIDING ENOUGH SUPPORT TO ADVANCE A 5 X 19 MM GORE V BX STENT. WITH REPEAT ATTEMPT USING AN 8.5 FRENCH OSCOR CONFORMABLE SHEATH, WIRE ACCESS TO THE CELIAC ARTERY WAS LOST.

  Patient problems: No Information

  MAUDE report 7665930 ↗
• InjurySep 7, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS AND HEAVILY CALCIFIED RIGHT CORONARY ARTERY. A 6F GUIDE WAS BEING USED AND A 5.0 X 28 MM ULTRA STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION AND THE STENT WAS DEPLOYED. THE STENT DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE. A 5.0 X 18 MM ULTRA WAS BEING ADVANCED TO TREAT THE LESION PROXIMAL TO THE DEPLOYED STENT WHEN THE STENT CAUGHT ON CALCIUM IN THE ARTERY AND THE STENT IMPLANT PARTIALLY DISLODGED AND WAS PARTIALLY EXPANDED IN THE ARTERY. IT IS UNKNOWN IF THE DEVICE WAS COMPLETELY IN HEALTHY TISSUE. A 5.0 BALLOON CATHETER WAS USED FOR POST DILATATION AND A 4.0 UNSPECIFIED XIENCE STENT WAS IMPLANTED TO BRIDGE THE TWO ULTRAS. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6848103 ↗
• MalfunctionJul 19, 2017Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A PROCEDURE OF THE NON-TORTUOUS, NON-CALCIFIED, THROMBOSED, RIGHT CORONARY ARTERY (RCA), THE 5.0 X 18 MM ULTRA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED IN A NON-ABBOTT GUIDELINER, BUT COULD NOT CROSS THE LESION DUE TO THE ANATOMY. DURING REMOVAL OF THE SDS FROM THE ANATOMY, THE STENT IMPLANT DISLODGED WHILE IN THE TUOHY ROTATING HEMOSTASIS VALVE (RHV), OUTSIDE THE ANATOMY. A NON-ABBOTT STENT SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6726157 ↗