Herculink Elite 1011498-18Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08717648078170), received between Oct 7, 2016 and Mar 28, 2017 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 28, 2017Improper or Incorrect Procedure or Method; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE TO TREAT SEVERE STENOSIS IN THE PROXIMAL SUPERIOR MESENTERIC ARTERY (SMA) AND SEVERE ILIAC STENOSIS. A 6 FRENCH GUIDE CATHETER WAS ADVANCED AND THE 6.0 X 18 MM HERCULINK STENT DELIVERY SYSTEM WAS ADVANCED; HOWEVER, THE STENT DISLODGED FROM THE DELIVERY CATHETER WHEN ATTEMPTING TO CROSS INTO THE SUPERIOR MESENTERIC ARTERY. THE DISLODGED STENT WAS ABLE TO BE PULLED INTO THE RIGHT MID COMMON ILIAC ARTERY USING A SNARE DEVICE. AN OMNILINK STENT WAS THEN DEPLOYED IN THE RIGHT MID COMMON ILIAC ARTERY TO CRUSH THE STENT TO THE VESSEL WALL. POST STENTING ANGIOGRAPHY NOTED THE STENT WIDELY PATENT. THE PROCEDURE CONTINUED WITH IMPLANTATION OF A 6.0 X 18 MM HERCULINK STENT IN THE SMA AND IMPLANTATION OF AN 8.0 X 29 MM OMNILINK STENT IN THE LEFT ILIAC ARTERY. POST STENTING ANGIOGRAPHY NOTED THE STENTS WIDELY PATENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6440825 ↗
• MalfunctionOct 7, 2016Inflation Problem; Material Rupture; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE SUBCLAVIAN ARTERY. THE 6.0MMX18MMX80CM HERCULINK ELITE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT RESISTANCE IN THE PATIENT ANATOMY. HOWEVER, THE BALLOON COMPLETELY FAILED TO INFLATE. THE SDS WAS REMOVED FROM THE PATIENT ANATOMY, WHILE OUTSIDE THE PATIENT ANATOMY THE SDS FAILED TO INFLATE AGAIN. A LEAK WAS NOTED COMING FROM THE BALLOON. A SAME SIZE HERCULINK SDS WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6012732 ↗