Express® LD Iliac / Biliary H74938046620750Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 08714729392132), received between Dec 19, 2016 and Feb 3, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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.

• InjuryFeb 3, 2025Fracture; Material Rupture; Failure to Advance; Device Dislodged or Dislocated; Fracture; Material Rupture; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENTS DISLODGED AND REQUIRED SURGICAL INTERVENTION. THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERIOR MESENTERIC ARTERY (SMA). A 6.0X20X75CM EXPRESS LD BALLOON EXPANDABLE STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE DID NOT TRACK THROUGH THE SMA, AND THE BALLOON RUPTURED WITHOUT BEING FULLY INFLATED. SUBSEQUENTLY, THE STENT FRACTURED AND DISLODGED FROM THE BALLOON AND GOT STUCK IN THE SMA THEN MIGRATED DOWN TO THE POPLITEAL ARTERY. THE SAME ISSUE OCCURRED WHEN ANOTHER EXPRESS LD BALLOON EXPANDABLE STENT WAS USED. THE PHYSICIAN ATTEMPTED TO SNARE THE DISLODGED STENTS BUT WAS UNSUCCESSFUL. AS A RESULT, AN EMERGENCY CUTDOWN WAS PERFORMED TO SUCCESSFULLY REMOVE THE STENTS, AND THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC (BSC) STENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL BEYOND THE STANDARD OF CARE BUT IS EXPECTED TO FULLY RECOVER. IT WAS FURTHER REPORTED THAT THE STENT WAS USED FOR MESENTERIC ANGIOGRAM. FURTHERMORE, IT WAS NOTED THAT THE STENT WAS DEPLOYED WITHOUT PHYSICIAN INITIATING THE DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294730 ↗
• InjuryJul 28, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED INSIDE THE PATIENT. THE 90-99% STENOSED TARGET LESION WAS LOCATED IN A NON-TORTUOUS AND SEVERELY CALCIFIED ARTERY. A 6.0 X 20 X 75CM EXPRESS LD ILIAC BILIARY BALLOON EXPANDABLE STENT WAS SELECTED FOR USE IN THE SUPERIOR MESENTERIC ARTERY TO TREAT HYPOGASTRIC STENOSIS. HOWEVER, DURING THE PROCEDURE, THE STENT DISLODGED FROM THE BALLOON. IT MIGRATED TO THE LEFT INTERNAL ILIAC ARTERY. ATTEMPTS WERE MADE TO REMOVE THE STENT VIA SURGERY, BUT IT WAS UNSUCCESSFUL. SINCE THE STENT EMBOLIZED DISTALLY, AND WAS UNABLE TO BE RETRIEVED, THE PROCEDURE WAS CANCELLED. THE PATIENT CONDITION WAS REPORTED AS OKAY AND THEN DISCHARGED HOME.

  Patient problems: Foreign Body In Patient

  MAUDE report 17413416 ↗
• MalfunctionMar 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 6.0 X 20 X 75CM EXPRESS LD ILIAC STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT WAS DETACHED FROM THE DELIVERY BALLOON. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT INCLUDING ITS DELIVERY CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8423122 ↗
• InjuryApr 10, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERIOR MESENTERIC ARTERY. A 6.0 X 20 X 75 CM EXPRESS® LD ILIAC / BILIARY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE COULD NOT BE ADVANCED AND UPON PUSHING THE DEVICE FOR A LITTLE BIT, THE STENT GOT DISLODGED FROM THE BALLOON INTO THE TARGET LESION. AFTER TWO HOURS OF UNSUCCESSFUL RETRIEVAL ATTEMPTS, THE STENT WAS THEN REMOVED BY SNARING. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7412886 ↗
• InjuryDec 19, 2016Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TIGHT TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 6.0X20X75CM EXPRESS® LD ILIAC / BILIARY STENT WAS ADVANCED TO TREAT THE LESION. THE STENT DISLODGED FROM THE DELIVERY SYSTEM WHILE CROSSING THE TIGHT LESION. A SNARE WAS USED TO RETRIEVE THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6187724 ↗