Express® LD Iliac / Biliary H74938047830130Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729579700), received between Jan 17, 2018 and Mar 25, 2026 — classified as 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 25, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 80% STENOSED LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PERIPHERAL ARTERY. AN 8.0 X 30 MM X 135 CM EXPRESS LD ILIAC / BILIARY STENT SYSTEM WAS ADVANCED; HOWEVER, DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING THE DEVICE OVER THE AORTIC ARCH. UPON CROSSING THE CALCIFIED LESION, THE STENT DISLODGED FROM THE DELIVERY BALLOON. THE STENT MIGRATED FROM THE COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. THE PHYSICIAN ELECTED TO KEEP THE DISLODGED STENT AND USED A BALLOON TO EXPAND IT AGAINST THE VESSEL WALL AT THE EXTERNAL ILIAC ARTERY WITHIN THE DISEASED SEGMENT. THE STENT WAS NOT REMOVED, AS THE PHYSICIAN DETERMINED IT WAS ACCEPTABLE TO DEPLOY IT AT THAT LOCATION. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689104 ↗
• MalfunctionJun 4, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATERIAL WAS PRESENT IN DEVICE. AN 8.0X30X135CM EXPRESS LD ILIAC/BILIARY STENT WAS SELECTED FOR USE IN AN ARTERIAL RUNOFF PROCEDURE. HOWEVER, DURING PREPARATION, IT WAS OBSERVED THAT THE STENT WAS SO SLICK, AND WAS THOUGHT TO HAVE SOME SORT OF PLASTIC PROTECTIVE COVER OVER THE STENT MARRYING IT TO THE BALLOON. THE DEVICE WAS REPLACED WITH ANOTHER EXPRESS LD STENT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19460961 ↗
• MalfunctionMay 21, 2024Difficult to Advance; Material Integrity Problem; Difficult to Advance; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03MAY2024. IT WAS REPORTED THAT DIFFICULTY ADVANCING AND TIP BENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN A SUB ARTERY. AN 8.0X30X135CM EXPRESS LD ILIAC/BILIARY STENT BALLOON EXPANDABLE WAS ADVANCED FOR TREATMENT. DURING INTRODUCTION, IT WAS NOTED THAT THE DEVICE WAS DIFFICULT TO GO THROUGH THE SHEATH AND THE FRONT TIP WAS A BIT BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND PATIENT STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A STENT DAMAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19361571 ↗
• MalfunctionApr 2, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT MOVED ON BALLOON. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS SUPERIOR MESENTERIC ARTERY. AN 8.0X30X135CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT BUT THE LESION WAS TOO TIGHT TO CROSS. THE DEVICE WAS REMOVED, AND DILATATION WAS PERFORMED WITH A BALLOON. THE STENT WAS BEING PREPARED TO BE LOADED ONTO THE 035 NON-BOSTON SCIENTIFIC (BSC) GUIDEWIRE FOR REINTRODUCTION; HOWEVER, IT WAS NOTED THAT THE STENT HAD LOOSENED AND WAS NOT CENTERED ON BALLOON. THE DEVICE WAS REMOVED FULLY INTACT, AND THE PROCEDURE WAS COMPLETED WITH A NEW 75CM-SHAFT EXPRESS LD ILIAC / BILIARY STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19021711 ↗
• MalfunctionJan 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVEMENT ON BALLOON OCCURRED. AN 8.0X30X135CM EXPRESS LD STENT WAS SELECTED FOR TREATMENT ON THE PATIENT. AFTER IT ENTERED THE SHEATH, IT DISPLACED ON THE BALLOON AND SLIGHTLY MIGRATED WITHIN THE BALLOON AREA. THE DEVICE WAS SIMPLY PULLED OUT AND WAS REPLACED WITH ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. THERE WERE NO COMPLICATIONS REPORTED, AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18609484 ↗
• InjuryMay 3, 2023Migration; Migration

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND NON-CALCIFIED RIGHT RENAL VEIN WITH A SIGNIFICANT BEND. AFTER A 0.35 GUIDEWIRE WAS ADVANCED, AN 8.0X30X135CM EXPRESS LD ILIAC / BILIARY STENT WAS DEPLOYED AT 10 ATMOSPHERES FOR 1 MINUTE AND THE STENT DELIVERY SYSTEM WAS REMOVED SUBSEQUENTLY. HOWEVER, WHEN THE PHYSICIAN TOOK A VENOGRAM, IT WAS NOTED THAT THE STENT MOVED INTO THE HEART. THE PHYSICIAN ATTEMPTED TO SNARE THE STENT BUT WAS UNSUCCESSFUL. A BALLOON WAS THEN ADVANCED AND INFLATED INSIDE THE STENT, AND THE STENT WAS PULLED BACK INTO THE ILIAC VEIN AND WAS CRUSHED AGAINST THE VESSEL WALL WITH A LONGER STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860302 ↗
• InjuryDec 7, 2022Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A STENT DISLODGEMENT AND REMOVAL DIFFICULTY OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT RADIAL ARTERY. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED SUBCLAVIAN ARTERY. FOLLOWING PRE-DILATION OF THE LEFT SUBCLAVIAN ARTERY, AN 8.0X30X135CM EXPRESS LD ILIAC/BILIARY STENT WAS ADVANCED BUT ENCOUNTERED DIFFICULTIES IN ADVANCING STENT THROUGH NON-BOSTON SCIENTIFIC SHEATH. DURING WITHDRAWAL, THE STENT DISLODGED FROM THE STENT DELIVERY SYSTEM. THE PRESSURE WAS DROPPED TO 018 SYSTEM IN AN ATTEMPT TO DRAG THE STENT OUT WITH A SMALL BALLOON BEHIND THE STENT. RETRIEVAL ATTEMPTS OF THE STENT FAILED AS THERE WAS TOO MUCH FRICTION. THE PHYSICIAN DEPLOYED THE STENT IN RADIAL ARTERY WITH 2.5 MM STERLING BALLOON CATHETER AT 14 ATMOSPHERES FOR 5 SECONDS. THE SUBCLAVIAN STENOSIS WAS TREATED WITH 035 CHARGER BALLOON ANGIOPLASTY ONLY. NO STENT WAS DEPLOYED IN THE SUBCLAVIAN. THE PHYSICIAN ABORTED THE PROCEDURE AFTER THE EXPRESS WAS DISLODGED AND DEPLOYED IN THE RADIAL ARTERY. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS DISCHARGED IN GOOD CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15932050 ↗
• MalfunctionAug 26, 2022Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 8.0X30X135CM EXPRESS LD ILIAC / BILIARY STENT WAS SELECTED FOR USE. AFTER A 6FR INTRODUCER SHEATH WAS INTRODUCED, THE PHYSICIAN TRIED TO ADVANCE THE STENT INTO THE VALVE OF THE SHEATH BUT WOULD NOT ADVANCE. HE THEN PUSHED THE STENT DELIVERY SYSTEM UNTIL THE STENT DISLODGED FROM THE BALLOON. THE DEVICE WAS PULLED MANUALLY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15303031 ↗
• MalfunctionApr 19, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. UPON UNPACKING OF AN 8.0X30X135CM EXPRESS LD ILIAC STENT, THE PROXIMAL STENT STRUTS WERE FOUND TO BE DAMAGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14139895 ↗
• InjuryMay 9, 2021Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated; Difficult to Remove; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT REMOVAL DIFFICULTY RESULTING IN STENT DISLODGEMENT AND VESSEL PERFORATION OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT COMMON ILIAC ARTERY. AN 8.0X30X135CM EXPRESS LD ILIAC STENT WAS ADVANCED FOR TREATMENT BUT FAILED TO CROSS THE LESION. THE PHYSICIAN TRIED TO PULL THE STENT CATHETER OUT; HOWEVER, IT PERFORATED THE POSTERIOR TIBIAL ARTERY (PTA). SWELLING WAS NOTED, AS A RESULT. IT WAS THEN ATTEMPTED TO BE ADVANCED FORWARD WHERE IT COULD BE DEPLOYED INTO A LARGER VESSEL, BUT THE STENT DISLODGED FROM THE DEVICE. A COVERED STENT WAS PLACED INTO THE PTA AFTER LONG BALLOON INFLATIONS WERE DEEMED UNSUCCESSFUL, BUT IT WAS NOTICED POST ANGIOGRAM THAT UPON SHEATH EXCHANGE, THE ARTERY HAD SPLIT OPEN DISTAL TO STENT PLACEMENT. AT THAT POINT, GROIN ANTEGRADE ACCESS WAS OBTAINED AND THE PATIENT WAS COILED AT THE PROXIMAL END OF THE ILIAC STENT. ANTERIOR TIBIAL ARTERY WAS THEN WIRED FROM GROIN ACCESS AND WAS INTERVENED ON IN ORDER TO GIVE THE PATIENT FLOW BACK TO HER FEET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADDITIONAL PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient; Perforation of Vessels; Swelling/ Edema

  MAUDE report 11795602 ↗
• InjuryJun 1, 2020Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON. THE TARGET LESION WAS LOCATED IN THE LEFT PROFUNDA VEIN. A 8.0X30X135CM EXPRESS LD ILIAC/BILIARY STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE STENT WAS COMING OFF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPRESS LD STENT. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10105835 ↗
• InjuryJun 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT COMMON ILIAC ARTERY (CIA). A 8.0X30X135CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON DEPLOYMENT, THE STENT CAME OFF THE BALLOON. IT WAS ATTEMPTED TO STEER THE DISLODGED STENT BACK, BUT THE STENT HAD TO BE DEPLOYED IN THE RIGHT PROFUNDA ARTERY. DILATATION WAS PERFORMED AND THE STENT WAS IMPLANTED. A SECOND, LARGER, 9X27MM STENT WAS THEN ADVANCED AND WAS PLACED IN THE CIA TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8663297 ↗
• MalfunctionFeb 12, 2019Entrapment of Device; Fracture; Device Dislodged or Dislocated; Entrapment of Device; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED. A 8.0X30X135CM EXPRESS LD ILIAC / BILIARY STENT WAS SELECTED FOR USE TO TREAT THE LESION WITHIN THE ILIAC ARTERY. DURING INTRODUCTION OUTSIDE THE PATIENT, THE DEVICE BECAME STUCK WHEN ENTERING THE 6F SHEATH AND THE STENT STRUTS WERE FOUND DETACHED FROM THE BALLOON AFTER REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8331352 ↗
• MalfunctionJul 3, 2018Premature Activation; Device Damaged Prior to Use; Premature Activation; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT PREMATURE DEPLOYMENT OCCURRED. AN 8.0X30X135CM EXPRESS® LD ILIAC / BILIARY STENT WAS SELECTED FOR USE TO TREAT A LESION. HOWEVER, DURING PREPARATION, WHILE THE DEVICE WAS NOT YET ATTACHED TO AN INFLATION UNIT, IT WAS NOTED THAT THE STENT WAS PARTIALLY DEPLOYED ON THE BALLOON. THE DEVICE WAS NEVER USED INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7660135 ↗
• MalfunctionJan 17, 2018Bent; Device Damaged Prior to Use; Bent; Device Damaged Prior to Use

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. DURING PREPARATION OF AN 8.0X30X135CM EXPRESS® LD ILIAC / BILIARY STENT, IT WAS NOTED THAT THE SURFACE OF THE STENT WAS UNEVEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7201489 ↗