Express® LD Iliac / Biliary H74938046630750Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729579656), received between Dec 20, 2021 and Oct 17, 2025 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED COMPLICATIONS POST STENT IMPLANTATION. ON THE (B)(6) 2023, A 6.0X30X75CM EXPRESS LD STENT WAS IMPLANTED IN THE RENAL ARTERY AND A CLOSURE DEVICE WAS USED ON THEIR ILIAC DURING AN ANEURYSM REPAIR COMPLICATION. SINCE THEN, THE PATIENT NEVER HAD A FOLLOW UP VISIT (SUCH AS MAGNETIC RESONANCE ANGIOGRAPH (MRA) OR COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA)). FOR OVER A YEAR, THE PATIENT HAD A BURNING SENSATION IN THEIR COCCYX AREA, FECAL INCONTINENCE, URINE INCONTINENCE, NUMBNESS IN THEIR RIGHT LEG AFTER WALKING A RELATIVELY SHORT DISTANCE THAT WOULD GET BETTER WITH REST, DIFFICULTY STANDING UP AFTER SITTING FOR A WHILE, THIRST, AND THE KIDNEYS INFARCTED TO THE POINT OF FALLING TO CHRONIC KIDNEY DISEASE (CKD) STAGE 3, A GLOMERULAR FILTRATION RATE (GFR) OF 50 THAT WAS THE LOWEST REGISTERED, AND HIGH BLOOD PRESSURE. THE PATIENT ALSO DEVELOPED POST-TRAUMATIC STRESS DISORDER (PTSD) BELIEVED TO BE BECAUSE THE PROCEDURE WAS PERFORMED WITHOUT ANESTHESIA. THE ONLY FOLLOW-UP THE PATIENT RECEIVED WAS A NON-CONTRAST COMPUTED TOMOGRAPHY (CT) SCAN THAT SHOWED THE STENT STILL IMPLANTED, AND A DOPPLER TEST TO CHECK ON THE FEMORAL AND EXTERNAL ILIAC ARTERY. IT WAS FURT

  Patient problems: Burning Sensation; Fecal Incontinence; High Blood Pressure/ Hypertension; Numbness; Renal Impairment; Urinary Incontinence

  MAUDE report 23328328 ↗
• 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21294720 ↗
• MalfunctionFeb 16, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED OUTSIDE THE PATIENT. THE PATIENT WAS BEING TREATED FOR ILIAC STENOSIS AND UNDERWENT STENTING. THE GREATER THAN 70% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. A 6.0X30X75CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. DURING REMOVAL, THE STENT CAME OFF THE WIRE OUTSIDE THE PATIENT. ANOTHER 6.0X30X75CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED BUT ALSO FAILED TO CROSS THE LESION. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18720647 ↗
• MalfunctionDec 20, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 6.0X30X75CM EXPRESS LD ILIAC STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTICED DURING PREPARATION THAT THE STENT CAME OFF THE BALLOON BEFORE INSERTED INTO THE SHEATH. THERE WERE NO REPORTED COMPLICATIONS NOR INJURIES ON THE PATIENT. IT WAS FURTHER REPORTED THAT THE STENT DID NOT DISLODGED AS PREVIOUSLY REPORTED BUT THE STENT MOVED A SHORT DISTANCE FROM THE STENT DELIVERY SYSTEM AND WAS NO LONGER CENTERED OVER THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13044638 ↗