Express® LD Iliac / Biliary H74938046104070Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729392095), received between Apr 10, 2018 and Nov 5, 2025 — classified as 4 injuries, 3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT STENT REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUBCLAVIAN ARTERY. A 10.0X40X75CM EXPRESS LD STENT BALLOON EXPANDING WAS SELECTED FOR USE. POST IMPLANTATION, IT WAS NOTED THAT THERE WAS RESISTANCE ENCOUNTERED AND THE BALLOON SEGMENT OF THE CATHETER BECAME DISCONNECTED. THE DISCONNECTED PORTION HAD REMAINED PARTIALLY WITHIN THE SHEATH; THEREFORE, THE SHEATH AND THE BROKEN CATHETER SEGMENT WERE ABLE TO BE REMOVED. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478445 ↗
• InjuryNov 11, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED, REQUIRING SURGICAL INTERVENTION FOR REMOVAL. THE TARGET LESION WAS LOCATED IN THE VERY TORTUOUS AND NON-CALCIFIED LEFT EXTERNAL ILIAC ARTERY. A 10.0X40X75CM EXPRESS LD STENT WAS USED FOR STENT PLACEMENT. HOWEVER, DURING THE PROCEDURE, THE STENT WOULD NOT CROSS THE LESION FROM THE CONTRALATERAL APPROACH. SUBSEQUENTLY, WHEN ATTEMPTING TO WITHDRAW THE STENT SYSTEM OUT OF THE PATIENT, IT WAS NOTED THAT THE STENT HAD DISLODGED FROM ITS DELIVERY SYSTEM AND WAS IN THE PATIENT UNDEPLOYED. THE STENT WAS SUCCESSFULLY REMOVED THROUGH A SMALL CUT DOWN SURGERY, AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE METHOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652267 ↗
• MalfunctionOct 27, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE PATIENT PRESENTED WITH CLAUDICATION AND UNDERWENT A LEFT LEG ANGIOGRAM. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ILIAC ARTERY. AFTER AN S/S XCH/035/180 AMPLATZ SUPER STIFF GUIDEWIRE WAS CROSSED THE LESION. A 10.0 X 40 X 75CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE DEPLOYMENT OF THE STENT, THE ENTIRE DEVICE WAS CRIMPED AND THE GUIDEWIRE FRAYED. THE PHYSICIAN THEN DEPLOYED AN ADDITIONAL EXPRESS LD ILIAC / BILIARY STENT TO COVER IT AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12703185 ↗
• InjuryMay 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT SUBCLAVIAN. A 10.0X40X75CM EXPRESS LD ILIAC WAS USED FOR TREATMENT. HOWEVER, THE STENT CAME OFF PRIOR TO DEPLOYMENT. THE STENT WAS RECAPTURED AND DEPLOYED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED. THERE WAS NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11837151 ↗
• InjuryApr 13, 2021Difficult to Remove; Material Rupture; Activation Failure; Difficult to Remove; Material Rupture; Activation Failure

  IT WAS REPORTED THAT STENT INADEQUATE APPOSITION, BALLOON RUPTURE AND DIFFICULTY REMOVAL OCCURRED. AN EXPRESS SD RENAL/BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING BALLOON EXPANSION, THE BALLOON RUPTURED AND WAS NOT ABLE TO BE REMOVED FROM THE STENT AFTER MANY TRIES. THE STENT WAS ONLY EXPANDED ON THE DISTAL TIP. BOTH THE STENT AND BALLOON ARE STILL IN THE PATIENT. INTERVENTION IS PLANNED TO REMOVE BOTH THE STENT AND BALLOON. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11657678 ↗
• MalfunctionSep 11, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 10.0X40X75CM EXPRESS LD ILIAC/BILIARY STENT WAS ADVANCED FOR TREATMENT AND WITHDRAWN UNDEPLOYED. THE EXPRESS STENT WAS THEN ADVANCED AGAIN AND IT WAS NOTED THAT THE DISTAL EDGE OF ONE STENT STRUTS WAS BENT. THE DEVICE WAS NO LONGER USED AND REPLACED WITH ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8994578 ↗
• InjuryApr 10, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED AND WAS IMPLANTED IN THE WRONG LOCATION. THE TARGET LESION WAS LOCATED IN THE RIGHT ILIAC ARTERY. A 10.0 X 40 X 75 CM EXPRESS® LD ILIAC / BILIARY STENT WAS ADVANCED TO TREAT THE LESION; HOWEVER, THE STENT CAME OFF THE STENT DELIVERY BALLOON. SUBSEQUENTLY, A SMALLER BALLOON CATHETER WAS USED TO DEPLOY THE DISLODGED STENT, FOLLOWED BY A LARGER BALLOON CATHETER TO FULLY DEPLOY THE STENT. THE STENT WAS SUCCESSFULLY DEPLOYED BUT IN THE WRONG LOCATION. THE PHYSICIAN ENCOUNTERED ACCESS ISSUES AND DECIDED TO TERMINATE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7418661 ↗