Express® LD Iliac / Biliary H74938046830750Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729579670), received between Mar 28, 2017 and Jul 30, 2025 — classified as 9 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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.

• InjuryJul 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED AND THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 8.0X30X75CM EXPRESS LD BALLOON STENT WAS USED FOR PROCEDURE. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE STENT DISLODGED FROM THE DELIVERY SYSTEM AND MOVED TO THE AORTA. ATTEMPTS WERE MADE TO SNARE AND RETRIEVE THE STENT, BUT THESE EFFORTS WERE UNSUCCESSFUL, AS THE STENT COULD NOT BE CAPTURED. THE PROCEDURE WAS NOT COMPLETED AND WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22664790 ↗
• InjuryFeb 5, 2024Positioning Failure; Entrapment of Device; Device Dislodged or Dislocated; Migration; Positioning Failure; Entrapment of Device; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT THE STENT BECAME STUCK ON THE GUIDEWIRE, THEN DISLODGED AND BECAME STUCK IN THE VESSEL, REQUIRING AN ADDITIONAL DEVICE. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ILIAC ARTERY. AN 8.0X30X75CM EXPRESS LD BALLOON EXPANDABLE STENT WAS PREPARED ACCORDINGLY AND WAS ATTEMPTED TO ADVANCE ON THE GUIDEWIRE. HOWEVER, WHEN THE LESION WAS REACHED, THE STENT BECAME STUCK ON THE GUIDEWIRE. WHEN ATTEMPTING TO REMOVE THE STENT, IT DISLODGED FROM THE BALLOON IN THE VESSEL, LEAVING THE CATHETER WITH THE BALLOON TO COME OUT. THE STENT TRAVELLED CREATING A STENOSIS IN THE EXTERNAL ILIAC; THEREFORE, THE PHYSICIAN TRIED TO SNARE THE STENT, BUT WAS UNSUCCESSFUL. THEY THEN USED A SMALLER BALLOON TO EXPAND THE STENT BUT WAS ALSO UNSUCCESSFUL. ANOTHER STENT WAS DEPLOYED TO PUSH THE DISLODGED STENT AGAINST THE WALL OF THE VESSEL. HOWEVER, THE SECOND STENT BECAME STUCK IN THE GUIDEWIRE WHEN ATTEMPTING TO REMOVE THE WIRE. THE GUIDEWIRE HAD TO BE CUT, LEAVING IT PARTIALLY STUCK IN THE EXPRESS LD AND INNOVA STENTS. A NON-BOSTON SCIENTIFIC STENT WAS IMPLANTED TO PREVENT THE OTHER STENTS AND DETACHED WIRE FROM MIGRATING. THE PATIENT EXPERIENCED DIS

  Patient problems: Discomfort; Foreign Body In Patient; Pain

  MAUDE report 18645828 ↗
• MalfunctionJan 4, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 8.0X30X75CM EXPRESS LD STENT WAS SELECTED FOR TREATMENT; HOWEVER, IT WAS NOTED THAT THE DEVICE WAS DAMAGED. ITS STRUTS WERE DEFORMED, HENCE, IT COULD NOT BE DEPLOYED. NO FURTHER INFORMATION WAS PROVIDED ON THE OUTCOME OF THIS PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18449462 ↗
• InjuryApr 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED LEFT COMMON ILIAC ARTERY. A 8.0X30X75CM EXPRESS LD STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, UPON INSERTION, THE SHEATH WAS NOT ADVANCED OVER THE LESION AND THE RIGHT CALCIFIED AREA MOVED THE STENT MOVED OFF THE BALLOON. A SNARE WAS USED TO REMOVE THE STENT BUT WAS UNSUCCESSFUL. AN ELUVIA STENT WAS THEN PLACED TO PIN THE EXPRESS STENT AND WAS NOTED TO BE FULLY APPOSED TO THE VESSEL WALL. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED AS THE PATIENT WAS FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16683559 ↗
• InjurySep 27, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 8.0X30X75CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE STENT WAS DETACHED AND HAD TO BE IMPLANTED IN A HEALTHY ARTERY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12537168 ↗
• MalfunctionAug 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BALLOON DETACHMENT OCCURRED. VASCULAR ACCESS HAS OBTAINED VIA THE RADIAL ARTERY. THE TARGET LESION WAS LOCATED IN THE SUBCLAVIAN ARTERY. A 8.0 X 30 X 75 CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED AND SUCCESSFULLY DEPLOYED. HOWEVER, UPON REMOVAL OF THE BALLOON CATHETER THROUGH THE SHEATH IN THE RADIAL ARTERY, THE BALLOON CAME OFF THE CATHETER DELIVERY SYSTEM AND WAS STUCK IN THE SHEATH. THE DETACHED BALLOON WAS REMOVED UPON REMOVAL OF THE SHEATH AND THE PROCEDURE COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8851214 ↗
• InjuryMay 10, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 8.0X30X75CM EXPRESS LD STENT WAS INSERTED WITHIN THE PATIENT AND THEN THERE WAS AN ATTEMPT TO REMOVE THE DEVICE; HOWEVER, DURING THE REMOVAL THE STENT DISLODGED WITHIN THE PATIENT. A MUSTANG BALLOON CATHETER WAS USED TO SUCCESSFULLY RETRIEVE THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT. NO PATIENT HARM OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8600024 ↗
• MalfunctionDec 17, 2018Difficult to Advance; Material Deformation; Difficult to Advance; Material Deformation

  IT WAS REPORTED STENT DAMAGE OCCURRED. A 8.0X30X75CM EXPRESS LD ILIAC / BILIARY WAS SELECTED FOR USE IN THE LEFT EXTERNAL ILIAC VEIN. THE STENT WAS INITIALLY UNABLE TO PASS THROUGH THE LESION. THE DEVICE WAS REMOVED SO THAT PRE-DILATION COULD BE PERFORMED. WHEN THE STENT WAS VIEWED UPON REMOVAL. THE END OF THE STENT WAS DAMAGED. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8170144 ↗
• InjuryDec 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 8.0X30X75CM EXPRESS LD STENT WAS SELECTED TO TREAT THE LESION. HOWEVER, WHEN THE DEVICE WAS DEPLOYED, IT WAS NOTED THAT THERE WAS NO STENT. THE PHYSICIAN SCANNED THE PATIENT'S BODY UNDER FLUOROSCOPY AND THROUGH THE SHEATH HOWEVER THE STENT WAS NOT LOCATED. ANOTHER STENT LARGER IN SIZE WAS SELECTED FOR TREATMENT AND WAS DEPLOYED WITHOUT ANY COMPLICATIONS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8160527 ↗
• MalfunctionJun 1, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FOREIGN MATTER WAS FOUND STUCK ON THE STENT. THE TARGET LESION WAS LOCATED IN THE SUPERIOR MESENTERIC ARTERY. AN 8.0X30X75CM EXPRESS® LD ILIAC / BILIARY STENT WAS SELECTED FOR USE TO TREAT THE LESION. HOWEVER, IT WAS NOTED THAT THERE WAS A STRING HANGING OFF OF THE STENT. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7561184 ↗
• InjuryApr 2, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE RIGHT EXTERNAL ILIAC ARTERY. FOLLOWING PRE-DILATATION, A 8.0X30X75CM EXPRESS® LD ILIAC / BILIARY STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. HOWEVER, WHEN THE DEVICE WAS REMOVED, THE STENT CAME OFF. THE STENT WAS RETRIEVED BY SNARING AND DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7388600 ↗
• InjuryFeb 5, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TIGHT TARGET LESION WAS LOCATED IN THE NON-CALCIFIED COMMON ILIAC ARTERY (CIA). AN 8.0X30X75CM EXPRESS® LD ILIAC / BILIARY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE STENT CAME OFF THE BALLOON AND THE PHYSICIAN HAD TO DEPLOY THE STENT IN THE EXTERNAL ILIAC ARTERY INSTEAD OF THE CIA. THE PROCEDURE WAS COMPLETED WITH AN 8.0X17X75CM EXPRESS® LD ILIAC / BILIARY STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7241743 ↗
• MalfunctionOct 4, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. DURING PREPARATION OF AN 8.0X30X75CM EXPRESS® LD ILIAC / BILIARY STENT, IT WAS NOTED THAT THE STENT CAME OFF. THE DEVICE NEVER ENTERED THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 6913295 ↗
• InjuryOct 3, 2017Device Damaged by Another Device; Device Dislodged or Dislocated; Device Damaged by Another Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON. THE TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). A 8.0X30X75CM EXPRESS® LD ILIAC / BILIARY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE GOT CAUGHT BETWEEN THE STENT STRUT A PREVIOUSLY DEPLOYED INNOVA STENTS. WHEN THE DEVICE WAS REMOVED, THE STENT HAD STARTED TO CAME OFF OF THE BALLOON. THE PHYSICIAN THEN DEPLOYED THE STENT IN THE MID SFA IN BETWEEN TWO OVERLAPPING INNOVA STENTS TO KEEP IT FROM FLOATING AWAY. THE PROCEDURE WAS THEN COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6911794 ↗
• MalfunctionMar 28, 2017Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE RADIOPAQUE MARKERBANDS WERE NOT VISIBLE ENOUGH. THE PATIENT UNDERWENT ARTERIOGRAM.. A 8.0X30X75CM EXPRESS® LD ILIAC / BILIARY STENT WAS ADVANCED AND DEPLOYED AT THE LESION. HOWEVER, THE STENT WAS NOT VISIBLE ENOUGH. THE PHYSICIAN HAD TO ACQUIRE MORE IMAGES TO MAKE SURE THE STENT WAS DEPLOYED IN THE PROPER AREA. THE PHYSICIAN DID TAKE A LONGER TIME AND A LITTLE MORE RADIATION THAN IT SHOULD TAKE IN A PROCEDURE. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6439730 ↗