Express® LD Iliac / Biliary H74938046102070Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729392071), received between Mar 6, 2020 and May 7, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THIS 10.0X30X75CM EXPRESS LD STENT WAS SELECTED FOR USE ON A CANINE. DURING THE PROCEDURE, ONCE THE STENT WAS EXPANDED, IT WAS NOTED THAT THE BALLOON POPPED FAR BELOW THE BURST PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21980577 ↗
• InjuryMay 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED, REQUIRING ADDITIONAL DEVICE FOR REMOVAL. A 10.0X30X75CM EXPRESS LD STENT WAS SELECTED FOR STENTING THE SUPERIOR MESENTERIC ARTERY. HOWEVER, THE STENT NOTED TO BE OFF CATHETER, BUT STILL ON THE WIRE. SNARE WAS USED TO REMOVED THE STENT FROM THE PATIENT AND NOTED TO BE INTACT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234945 ↗
• MalfunctionApr 9, 2024

  STENT NOTED TO BE OFF CATHETER, BUT STILL ON THE WIRE. SNARE USED TO REMOVE STENT FROM THE PATIENT AND NOTED TO BE INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19069865 ↗
• MalfunctionFeb 20, 2023Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT ON GUIDEWIRE OCCURRED. THE TARGET LESION WAS LOCATED IN ILIAC ARTERY. A 10.0X30X75CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT DELIVERY SYSTEM WAS STUCK ON THE WIRE. THE DELIVERY SYSTEM AND THE WIRE WERE REMOVED AS A WHOLE ALL TOGETHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPRESS LD STENT. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED. IT WAS FURTHER REPORTED VIA ATTACHED FACILITY MEDWATCH REPORT 3600510000-2023-8002, THE PATIENT WAS BEING TREATED WITH ABDOMINAL ANGIOGRAM WITH RUNOFF AND POSSIBLE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE STENT WAS STUCK ON 035 AMPLATZ PLATINUM WIRE AND FAILED TO DEPLOY. THE PATIENT CONDITION WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404967 ↗
• InjuryMar 6, 2020Material Rupture; Activation Failure; Material Rupture; Activation Failure

  IT WAS REPORTED THAT BALLOON RUPTURE, STENT INADEQUATE APPOSITION, AND VESSEL DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT COMMON ILIAC VESSEL. FOLLOWING PRE-DILATATION WITH AN 8X40 BALLOON, A 10.0X30X75CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON INFLATING THE BALLOON INSIDE THE STENT, THE BALLOON RUPTURED. THE BALLOON WAS PULLED OUT. THE STENT WAS NOTED TO BE DOG-BONED, WHICH COULD NOT FULLY INFLATE THE STENT. ANOTHER NON-BSC BALLOON WAS USED TO POST DILATE THE STENT. THERE WAS A SLIGHT DISSECTION NOTED FROM THE COMMON ILIAC TOWARDS THE AORTA AND THE PHYSICIAN POST DILATED IT AGAIN WITH THE NON-BSC BALLOON. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT DID GOOD.

  Patient problems: Vascular Dissection

  MAUDE report 9799961 ↗