Express® LD Iliac / Biliary H74938046106070Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729392118), received between Jul 31, 2023 and Oct 7, 2024 — classified as 2 injuries, 1 malfunction.

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 18, 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.

• InjuryOct 7, 2024Difficult or Delayed Positioning; Difficult to Advance; Device Dislodged or Dislocated; Difficult or Delayed Positioning; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED, REQUIRING PLACEMENT OF ANOTHER STENT. THE OVER THAN 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED VESSEL. THE PATIENT PRESENTED WITH BILATERAL COMMON ILIAC ARTERY (CIA) DISEASE, UNDERWENT A PROCEDURE USING BILATERAL FEMORAL ACCESS. TWO 10.0X60X75CM EXPRESS LD STENTS WERE PLACED IN THE OSTIUM OF THE COMMON ILIAC ARTERY. DURING THE INSERTION ON THE RIGHT SIDE, THE PHYSICIAN ENCOUNTERED RESISTANCE. UNDER ANGIOGRAPHY, THE STENT WAS STILL ON THE CATHETER, SO THE STENT WAS INFLATED SIMULTANEOUSLY. HOWEVER, IT WAS NOTED THAT ONLY THE TOP HALF OF THE STENT WAS EXPANDED, WHILE THE BOTTOM PART REMAINED UNEXPANDED. THE BALLOON WAS REMOVED, AND A NEW BALLOON WAS ADVANCED TO INFLATE THE UNEXPANDED PART BUT WAS UNSUCCESSFUL. THE PHYSICIAN LOST WIRE ACCESS AND HAD TO COME CONTRALATERAL SIDE WITH A NEW WIRE BUT WAS UNABLE TO GET TRUE LUMEN THROUGH THE STENT. SUBSEQUENTLY, THE PHYSICIAN PLACED ANOTHER WIRE BESIDE THE STENT, CRUSHED IT AGAINST THE ARTERY WALL, AND PLACED ANOTHER EXPRESS LD OVER IT TO LOCK IT IN PLACE. AS PER PHYSICIAN'S OPINION, THE STENT MAY HAVE PARTIALLY SLID OFF THE BALLOON DURING THE PR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20385421 ↗
• MalfunctionJan 23, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 10.0X60X75CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT, THE BALLOON SEEMED TO HAVE BURST. UPON REMOVAL, IT APPEARED AS THOUGH THERE WAS A SMALL HOLE IN THE PART OF THE BALLOON. THE DEVICE WAS REMOVED FROM STERILE FIELD, WIPED TWICE, AND BAGGED TWICE. IT WAS NOTED THAT THE PHYSICIAN WAS NOT CONCERNED ABOUT ANY PIECES OF THE BALLOON REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18565235 ↗
• InjuryJul 31, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA CONTRALATERAL APPROACH. THE TARGET LESION WAS LOCATED IN ILIAC ARTERY. A 10.0X60X75CM EXPRESS LD ILIAC STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT CAME OFF THE BALLOON AT THE BIFURCATION. THE PHYSICIAN OPTED TO TRANSFER THE PATIENT TO A DIFFERENT HEALTHCARE FACILITY. IT WAS DETERMINED THE OTHER HEALTHCARE FACILITY WOULD HAVE BETTER EQUIPMENT AND BACKUP TO RETRIEVE THE STENT. BEFORE TRANSFERRING THE PATIENT TO THE NEW HEALTHCARE FACILITY, THE STENT WAS MOVED FROM OUT OF THE BIFURCATION TO THE AORTA. IT WAS THEN SNARED IN ORDER TO SECURE THE STENT DURING TRANSPORT TO THE NEW HEALTHCARE FACILITY. AFTER ARRIVAL AT THE NEW HEALTHCARE FACILITY, A LARGE DRY SHEATH AND SNARE WERE USED TO PULL THE STENT OUT. FINALLY. BOTH ILIAC ARTERIES WERE THEN STENTED. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17425623 ↗