Express® LD Iliac / Biliary H74938046730750Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729579663), received between May 15, 2018 and May 1, 2025 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2025Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED, REQUIRING INTERVENTION. THE TARGET LESION WAS LOCATED IN THE TORTUOUS AND SEVERELY CALCIFIED OSTIAL STENOSIS OF THE CELIAC ARTERY. VASCULAR ACCESS WAS OBTAINED VIA THE RIGHT COMMON FEMORAL ARTERY TO THE CELIAC ARTERY. A 6F NON-BOSTON SCIENTIFIC GUIDE SHEATH WAS PLACED, AND A 7.0 X 30 X 75 CM EXPRESS LD STENT BALLOON EXPANDABLE WAS ADVANCED FOR TREATMENT OVER .035 WIRE. IT WAS NOTED THAT THE GUIDE SHEATH WAS ONLY PARTIALLY INTO THE CELIAC ARTERY, AND AN ATTEMPT WAS MADE TO ADVANCE THE BALLOON/STENT OVER THE WIRE AND PAST THE LESION. HOWEVER, WHEN ADVANCING, THE BALLOON PUSHED FORWARD, CAUSING THE WIRE TO LOSE ACCESS IN THE CELIAC ARTERY, AND MOVE FORWARD IN THE AORTA. WHEN ATTEMPTING TO PULL BACK THE STENT INTO THE SHEATH, THE STENT DISLODGED FROM THE BALLOON SHAFT. A SNARE WAS USED TO PULL THE STENT BACK TO THE COMMON FEMORAL ARTERY; HOWEVER, A SURGICAL CUTDOWN WAS PERFORMED TO REMOVE THE STENT. THE PROCEDURE WAS CANCELLED, AND THE PATIENT WAS UNDER LOCAL ANESTHESIA. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21945293 ↗
• MalfunctionSep 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT MOVED ON BALLOON THE TARGET LESION WAS LOCATED IN THE CALCIFIED ILIAC ARTERY. A 7.0 X 30 X 75 CM EXPRESS LD STENT BALLOON EXPANDABLE WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT MOVED ON BALLOON. NO PATIENT COMPLICATION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20284364 ↗
• InjuryApr 17, 2023Material Separation; Activation Failure; Material Separation; Activation Failure

  IT WAS REPORTED THAT STENT DID NOT FULLY DEPLOY, AND BALLOON DETACHMENT OCCURRED. THE PATIENT PRESENTED WITH PERIPHERAL ARTERY DISEASE (PAD). THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC ARTERY. A 7.0X30X75CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT DID NOT FULLY DEPLOY WHEN THE PHYSICIAN REMOVED THE STENT DELIVERY SYSTEM (SDS). THE BALLOON OF THE SDS TORE ABOUT LEAVING THE BALLOON IN THE BODY. THE PHYSICIAN THEN GAINED ACCESS ON THE OTHER SIDE AND WAS ABLE TO REMOVE THE BALLOON FROM THE BODY WITH A SNARE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED AND PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16756006 ↗
• MalfunctionSep 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON. THE NARROWING TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND STRAIGHT VESSEL IN PROXIMAL ILIAC. A 7.0X30X75CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, AFTER DELIVERING THE STENT TO THE ILIAC ARTERY USING UP AND OVER APPROACH, IT WAS NOTED THAT THE STENT MOVED FORWARD ON THE BALLOON DELIVERY SYSTEM. THE DEVICE WAS REMOVED INTACT AND ONCE IT WAS SAFELY OUT THE SHEATH, IT WAS PHYSICALLY OBSERVED THAT THE STENT SLID SLIGHTLY FORWARD ON BALLOON AND NOT OFF BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER 7.0X30X75CM EXPRESS LD ILIAC / BILIARY STENT. THE CASE OUTCOME WENT GREAT, WITH NO PATIENT CONSEQUENCES AT ALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422589 ↗
• InjuryMar 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGEMENT OCCURRED. TWO 7.0X30X75CM EXPRESS LD ILIAC / BILIARY STENTS WERE SELECTED TO TREAT THE LESION. HOWEVER, DURING DELIVERY, BOTH STENTS FELL OFF THE BALLOON. SUBSEQUENTLY, A SNARE WAS USED TO REMOVE THE STENTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND TORTUOUS COMMON ILLIAC ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11485379 ↗
• InjuryMar 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGEMENT OCCURRED. TWO 7.0X30X75CM EXPRESS LD ILIAC / BILIARY STENTS WERE SELECTED TO TREAT THE LESION. HOWEVER, DURING DELIVERY, BOTH STENTS FELL OFF THE BALLOON. SUBSEQUENTLY, A SNARE WAS USED TO REMOVE THE STENTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11485344 ↗
• InjurySep 17, 2020Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 7.0X30X75CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT BUT COULD NOT CROSS THE LESION. THE PHYSICIAN DECIDED TO WITHDRAW THE STENT TO PRE-DILATE THE LESION. HOWEVER, AFTER REMOVING THE DEVICE OUT OF THE SHEATH, IT WAS NOTED THAT THE STENT WAS NO LONGER ATTACHED TO THE STENT DELIVERY SYSTEM BALLOON. UPON IMAGING, THE STENT WAS FOUND LODGED AT THE END OF THE SHEATH. THE PHYSICIAN WAS NOT ABLE TO REMOVE THE STENT FROM THE ARTERY. THE PHYSICIAN ADVANCED THE STENT NEAR THE LESION TO FULLY DEPLOY IT. THE STENT WAS THEN FULLY DEPLOYED BUT NOT IN THE OPTIMAL LOCATION. SUBSEQUENTLY, A SECOND STENT WAS PLACED TO FULLY COVER THE LESION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10547119 ↗
• MalfunctionMay 13, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED. AFTER A 7FR SHEATH WAS INSERTED, A 7.0X30X75CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTED THAT THE STENT BECAME STUCK IN THE SHEATH AND WAS UNABLE TO DEPLOY UPON INSERTION. UPON REMOVAL OF THE BALLOON, THE STENT WAS CAPTURED BY THE BALLOON. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10051998 ↗
• MalfunctionJul 10, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. A 7.0X30X75CM EXPRESS LD ILIAC/BILIARY STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE STENT GOT CAUGHT OVER THE WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8776148 ↗
• MalfunctionJun 18, 2019Failure to Advance; Physical Resistance/Sticking

  DURING PRE-OP INSPECTION, STENT GOT CAUGHT OVER WIRE. UNABLE TO ADVANCE OR REMOVE STENT ON WIRE. THIS DID NOT REACH THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8707084 ↗
• InjurySep 27, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 7.0X30X75CM EXPRESS LD WAS SELECTED TO TREAT A STENOSED LESION IN THE ILIAC VEIN. DURING THE PROCEDURE WHILE INSIDE THE PATIENT, THE STENT CAME OFF THE BALLOON. THE STENT WAS RECOVERED AND ANOTHER STENT WITH A 135CM SHAFT WAS SELECTED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE POST PROCEDURE. DEVICE EVALUATED BY MANUFACTURER: A VISUAL AND MICROSCOPIC EXAMINATION WAS PERFORMED ON THE RETURNED DEVICE, THE FOLLOWING ATTRIBUTES WERE EXAMINED: THE DELIVERY SYSTEM WAS RETURNED FOR ANALYSIS WITH THE STENT FULLY MOUNTED ONTO THE DELIVERY SYSTEM. A VISUAL AND TACTILE EXAMINATION ON THE CATHETER IDENTIFIED ONE KINK ON THE CATHETER OF THE DEVICE APPROXIMATELY 1MM DISTAL TO THE STRAIN RELIEF. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE BEING APPLIED TO THE DELIVERY SYSTEM. NO ISSUES WERE NOTED WITH THE SHAFT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT INCIDENT. A VISUAL AND MICROSCOPIC EXAMINATION WAS PERFORMED ON THE TIP AND MARKERBANDS OF THE DEVICE. NO DAMAGE OR ANY ISSUES WERE NOTED WITH THE TIP OR MARKERBANDS OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT IN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7915197 ↗
• InjuryMay 15, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 7.0X30X75CM EXPRESS® LD ILIAC / BILIARY STENT WAS ADVANCED TO TREAT THE LESION. WHEN THE PHYSICIAN ADVANCED THE DEVICE THROUGH A SHEATH OR A GUIDE CATHETER, THE STENT CAME OFF THE BALLOON. THE PHYSICIAN ATTEMPTED TO SNARE THE DISLODGED STENT BUT THE SNARING DEVICE TANGLED IN THE STENT. THE PATIENT THEN WAS TAKEN TO THE OPERATING ROOM FOR A NON-SCHEDULED SURGERY TO REMOVE THE DISLODGED STENT. THE STENT WAS REMOVED AND A DIFFERENT STENT WAS DEPLOYED. THE PROCEDURE WAS THEN COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7515286 ↗