Express® LD Iliac / Biliary H74938047630130Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729579687), received between Nov 21, 2018 and Nov 15, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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.

• InjuryNov 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DEVICE DISLODGEMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL SUPERFICIAL FEMORAL ARTERY. A 6.0X30X135CM EXPRESS LD STENT WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE STENT SEPARATED FROM THE BALLOON, REQUIRING THE USE OF A SNARE TO SUCCESSFULLY RETRIEVE THE STENT AND REMOVE IT FROM THE PATIENTS BODY. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695510 ↗
• MalfunctionApr 8, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 6.0X30X135CM EXPRESS LD ILIAC / BILIARY STENT WAS SELECTED FOR TREATMENT OF PERIPHERAL ARTERY DISEASE. HOWEVER, PRIOR TO THE PROCEDURE, IT LOOKED LIKE THE TECH FAILED TO FLUSH THE HOOP AS THERE WAS TOO MUCH RESISTANCE WITH THE DEVICE, AND THE SHAFT SEPARATED AT THE PROXIMAL THIRD. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19061674 ↗
• MalfunctionJan 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE PATIENT PRESENTED FOR ARTERIAL STENTING PROCEDURE. DURING UNPACKING OF A 6.0X30X135CM EXPRESS LD ILIAC/BILIARY STENT, THERE WAS NO STENT ATTACHED AND THE STENT WAS FOUND LYING ON THE TABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16109817 ↗
• MalfunctionJun 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED SUPERIOR MESENTERIC ARTERY WITH SEVERE ANGULATION AT TAKEOFF OF VESSEL FROM AORTA. AFTER ENGAGING THE LESION WITH A NON-BSC SHEATH AND 0.035 AMPLATZ GUIDEWIRE, A 6.0X30X135CM EXPRESS LD STENT WAS DELIVERED INTO THE LESION. THE SHEATH POSITION HAD TO BE ADJUSTED AND THE STENT WAS PULLED BACK INTO THE SHEATH. DUE TO THE SEVERE ANGLE OF THE STEERABLE SHEATH AT THE TIP, THE STENT WAS PULLED OFF OF THE BALLOON CATHETER AS IT WAS RETRACTED BACK INTO THE SHEATH THROUGH THE CURVED TIP OF THE SHEATH. THIS WAS NOTICED IMMEDIATELY AND THE ENTIRE SHEATH SYSTEM, ALONG WITH THE WIRE AND STENT DELIVERY SYSTEM, WAS REMOVED. THE STENT WAS RETRIEVED FROM THE SHEATH AND NOTHING REMAIN IN THE PATIENT'S BODY. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10123245 ↗
• InjuryNov 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 6.0X30X135CM EXPRESS LD ILIAC / BILIARY STENT WAS USED FOR TREATMENT. IT WAS NOTICED THAT THE STENT WAS EXTENDED THROUGH CALCIUM AND THE STENT CAME LOOSE FROM THE BALLOON, AND IT DISLODGE IN THE ARM, AND AN UNSPECIFIED 3MM BALLOON WAS INSERTED OVER AN UNSPECIFIED 035 WIRE TO "POST THE BALLOON." NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8097298 ↗