Express® LD Iliac / Biliary H74938047140130Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729392385), received between Oct 15, 2018 and Nov 21, 2024 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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.

• InjuryNov 21, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT CAME OFF FROM THE BALLOON. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATE TO SEVERELY CALCIFIED BILATERAL COMMON ILIAC. TWO 10.0X40X135 CM EXPRESS LD ILIAC / BILIARY STENT BALLOON EXPANDABLE CATHETERS WERE SELECTED AND ADVANCED FOR BILATERAL COMMON ILIAC 'KISSING STENTS' PROCEDURE. HOWEVER, THE STENTS WERE DIFFICULT TO CROSS THE LESION, AND BOTH STENTS CAME OFF FROM THE BALLOON. A SMALLER DIAMETER MUSTANG BALLOON WAS USED TO CROSS THROUGH THE STENTS AND THEN FULLY DEPLOY THE TWO STENTS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20750101 ↗
• InjuryNov 21, 2024Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT CAME OFF FROM THE BALLOON. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATE TO SEVERELY CALCIFIED BILATERAL COMMON ILIAC. TWO 10.0 X 40 X 135 CM EXPRESS LD ILIAC / BILIARY STENT BALLOON EXPANDABLE CATHETERS WERE SELECTED AND ADVANCED FOR BILATERAL COMMON ILIAC 'KISSING STENTS' PROCEDURE. HOWEVER, THE STENTS WERE DIFFICULT TO CROSS THE LESION, AND BOTH STENTS CAME OFF FROM THE BALLOON. A SMALLER DIAMETER MUSTANG BALLOON WAS USED TO CROSS THROUGH THE STENTS AND THEN FULLY DEPLOY THE TWO STENTS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20749922 ↗
• InjuryNov 29, 2021Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 83% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED RIGHT COMMON ILIAC ARTERY. AFTER A 7X10 NON BOSTON SCIENTIFIC SHEATH WAS PLACED, A .035 GUIDEWIRE WAS INSERTED ALONG WITH PIGTAIL THEN EXCHANGED FOR A .018X300 STEEL CORE WIRE TO PERFORM INTRAVENOUS ULTRASOUND (IVUS). AFTER IVUS THE PIGTAIL WAS REINSERTED AND WIRE EXCHANGE WAS PERFORMED WITH .035 WIRE. A 10.0 X 40 X 135 CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT AND THE DEVICE COULD NOT ADVANCE PAST THE LESION. THE PHYSICIAN THEN EXCHANGE TO A LONGER SHEATH BUT UPON REMOVAL OF THE STENT THE STENT WAS STRIPPED FROM THE BALLOON AT THE EDGE OF THE SHEATH. THE SHEATH WAS THEN REMOVED TO BE EXCHANGED FOR A 7X23CM SHEATH. FLUOROSCOPY WAS PERFORMED REVEALING THE STENT ON THE WIRE IN THE COMMON FEMORAL ARTERY (CFA). A DILATOR WAS ADVANCED INTO THE STENT TO HOLD IT IN PLACE, AND SURGERY WAS CALLED FOR REMOVAL. A CUTDOWN OF THE RIGHT COMMON FEMORAL ARTERY WAS THEN PERFORMED AND STENT WAS REMOVED. THE PATIENT WILL BE BROUGHT BACK FOR STENT OF COMMON ILIAC ARTERY. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12883706 ↗
• MalfunctionNov 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 10.0X40X135 CM EXPRESS LD ILIAC / BILIARY STENT WAS SELECTED FOR USE. HOWEVER, DURING UNPACKING IT WAS NOTICED THAT THE STENT HAD CAME OFF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12804780 ↗
• MalfunctionSep 8, 2020Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 10.0X40X135 CM EXPRESS LD STENT WAS DEPLOYED. UPON REMOVAL, THE BALLOON BECAME CAUGHT IN THE SHEATH AND THE SHAFT BROKE. THE DEVICE WAS REMOVED AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10505002 ↗
• MalfunctionMar 12, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 10.0X40X135 CM EXPRESS LD ILIAC BILIARY STENT WAS SELECTED FOR USE FOR A STENTING PROCEDURE IN THE ARM. HOWEVER, DURING PREPARATION, IT WAS NOTED THAT THE END OF THE STENT WAS DEFORMED. THE PROCEDURE WAS COMPLETED WITH DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8413453 ↗
• MalfunctionOct 15, 2018Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED STENT DISLODGEMENT OCCURRED. A 10.0X40X135 CM EXPRESS LD ILIAC / BILIARY STENT WAS USED TO ADVANCED THROUGH THE NON-BSC 7FR SHEATH, RESISTANCE WERE ENCOUNTERED AND IT DID NOT CROSS THE LESION. THE DEVICE WAS REMOVED AND NOTICED THAT THE STENT BECAME DISMOUNTED FROM THE CATHETER OUTSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE THAT FIT THROUGH THE SHEATH. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7965789 ↗