Express® LD Iliac / Biliary H74938046920750Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729392316), received between Aug 1, 2017 and Apr 12, 2024 — 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.

• MalfunctionApr 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 9.0X30X75CM EXPRESS LD ILIAC / BILIARY STENT BALLOON WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PREPARATION, IT WAS FOUND THAT THE STENT WAS NOT ATTACHED TO THE DELIVERY SYSTEM WHEN PULLING OUT FROM THE LOOP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19101418 ↗
• MalfunctionOct 28, 2019Device Contaminated During Manufacture or Shipping; Packaging Problem; Device Contaminated During Manufacture or Shipping; Packaging Problem

  IT WAS REPORTED THAT DEVICE STERILITY WAS COMPROMISED. IT WAS OBSERVED THAT AN EXPRESS LD ILIAC / BILIARY STENT PRODUCT BOX AND DEVICE PACKAGE WAS RECEIVED DAMAGED AND THE PRODUCT POUCH WAS COMPROMISED.THE EXPRESS STENT WAS NOT USED FOR A PROCEDURE.

  Patient problems: No Patient Involvement

  MAUDE report 9244391 ↗
• InjuryNov 2, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT COMMON ILIAC ARTERY. A 9.0X30X75CM STENT WAS ADVANCED BUT DEVICE WAS UNABLE TO CROSS THROUGH A PREVIOUSLY IMPLANTED STENT. THE PHYSICIAN ATTEMPTED TO PUSH THE DEVICE THROUGH THE PREVIOUSLY IMPLANTED STENT AND DEVICE GOT CAUGHT WITH IMPLANTED STENT THEN THE STENT STARTED TO SLIDE OFF THE BALLOON. THE DEVICE WAS REMOVED AND THE PHYSICIAN DECIDED TO RE-INTRODUCE THE SAME DEVICE. AFTER THE DEVICE WOULD NOT CROSS THE AFFECTED LESION, THE PHYSICIAN TRIED TO PULL THE DEVICE OUT OF THE PATIENT'S BODY BUT THE DEVICE GOT CAUGHT ON THE SHEATH AND THE STENT COMPLETELY SLID OFF THE BALLOON. AN ATTEMPT TO REMOVE THE DISLODGED STENT WAS MADE BUT WAS UNSUCCESSFUL. THE BALLOON WAS THEN RE-INSERTED INTO THE LUMEN OF THE DISLODGED STENT AND DEPLOYED IN A DIFFERENT SECTION IN THE ILIAC ARTERY. A NON-BSC STENT WAS ADVANCED BUT STILL FAILED WITH THE SAME RESULT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6997626 ↗
• InjuryAug 1, 2017Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED AND MIGRATED INSIDE THE PATIENT REQUIRING SURGERY. THE TARGET LESION WAS LOCATED IN THE RIGHT ILIAC ARTERY. AFTER A 7FR SHEATH WAS INSERTED, A 9.0X30X75CM EXPRESS® LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING ADVANCEMENT THROUGH THE STENOSIS, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN ATTEMPTED TO PULL THE DEVICE BACK BUT THE STENT DISLODGED FROM THE DELIVERY SYSTEM. SUBSEQUENTLY, THE PHYSICIAN ATTEMPTED TO RETRIEVE THE DISLODGED STENT WITH A SNARE BUT WAS UNSUCCESSFUL AND THE STENT MIGRATED TO THE SUPERFICIAL FEMORAL ARTERY. THE PATIENT WAS THEN SENT FOR SURGERY AND THE DISLODGED STENT WAS REMOVED BY A VASCULAR SURGEON. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS IN SATISFACTORY CONDITION, UPON COMPLETION OF THE SURGICAL PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6756341 ↗