Express® LD Iliac / Biliary H74938047840130Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729392477), received between Jun 7, 2018 and Jun 26, 2024 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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.

• InjuryJun 26, 2024Fracture; Defective Device; Migration; Fracture; Defective Device; Migration

  IT WAS REPORTED THAT THE DEVICE BROKE, AND A PIECE REMAINED INSIDE THE PATIENT. THIS 8.0X40X135 CM EXPRESS LD ILIAC / BILIARY WAS REPORTED TO HAVE BROKEN AND A PIECE REMAINED INSIDE THE PATIENT. ADDITIONAL DETAILS HAVE BEEN REQUESTED BUT ARE UNAVAILABLE AT THIS TIME. IT WAS FURTHER REPORTED THAT DURING A PROCEDURE FOR AN ACUTE TYPE B AORTIC DISSECTION AND OCCLUDED CELIAC ARTERY WITH MALPERFUSION OF THE SUPERIOR MESENTERIC ARTERY (SMA), A NON-BOSTON SCIENTIFIC DISSECTION STENT WAS PLACED EXTENDING DISTALLY. THE SMA WAS STILL STENOSED; THEREFORE, THIS 8.0X40X135 CM EXPRESS LD ILIAC / BILIARY STENT WAS PLACED TO OPEN THE SMA ORIGIN. SUBSEQUENT ROUTINE IMAGING WAS PERFORMED WHICH DEMONSTRATED THAT THE STENT FRACTURED WITH ONE PART REMAINING IN THE SMA ORIGIN AND THE OTHER DISLODGED DISTALLY IN THE SMA TRUNK. THIS FRACTURED SMA STENT WAS THEN OPPOSED TO THE SMA WALL WITH BALLOON ANGIOPLASTY, AND THEN IT WAS ATTEMPTED TO TRY TO RELINE THE SMA STENT TO TRAP THE PIECE THAT MIGRATED DISTALLY. THE PATIENT DID NOT HAVE ANY SYMPTOMS FROM THIS AND THE SMA REMAINED OPEN.

  Patient problems: Foreign Body In Patient

  MAUDE report 19615128 ↗
• InjuryMay 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED ILIAC ARTERY. AFTER OBTAINING CONTRALATERAL ACCESS WITH A 6FR SHEATH, AN 8.0X40X135 CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT DISMOUNTED DURING POSITIONING. A SNARE WAS USED TO RETRIEVE THE STENT. THE PROCEDURE WAS COMPLETED WITH A NEW STENT AND A 7FR SHEATH. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19343265 ↗
• MalfunctionJul 11, 2023Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON. THE 95% STENOSED TARGET LESION WAS AN AREA OF BIFURCATION LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED ILIAC ARTERY. AFTER INSERTING A 6FX45CM NON-BOSTON SCIENTIFIC (BSC) GUIDING SHEATH, AN 8.0X40X135 CM EXPRESS LD ILIAC/BILIARY STENT WAS ADVANCED OVER A 035 260CM NON-BSC GUIDEWIRE. HOWEVER, DURING INTRODUCTION, THE DEVICE WAS DIFFICULT TO ADVANCE AND COULD NOT GET OVER THE BIFURCATION AS IT WAS TOO STEEP. IT WAS NOTICED THAT THE STENT WAS MOVING ALONG THE BALLOON WHILE STILL INSIDE THE SHEATH. THE ENTIRE SHEATH ALONG WITH THE STENT AND BALLOON WERE SAFELY REMOVED. AFTER INSERTING A NEW GUIDING SHEATH AND CROSSING THE LESION WITH AN AMPLATZ SUPER STIFF GUIDEWIRE, ANOTHER 8.0X40X135 CM EXPRESS LD ILIAC/BILIARY STENT WAS ADVANCED AND DEPLOYED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17299090 ↗
• MalfunctionNov 25, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON LEAK OCCURRED. THE PATIENT PRESENTED WITH SEVERE LEFT EXTERNAL ILIAC ARTERY (EIA) STENOSIS. THE 92% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LEFT EIA. THERE WAS QUITE A LARGE CALCIUM SHELF IN THE VESSEL. A 8.0X40X135 CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED; HOWEVER, DURING INFLATION, A CONTRAST WAS NOTICED COMING FROM THE BOTTOM OF THE BALLOON AND THE BALLOON WOULD NOT INFLATE. THE PHYSICIAN THOUGHT THAT IT MAY BE THE LARGE CALCIUM SHELF THAT CAUSED A PINPOINT HOLE IN THE BOTTOM OF THE BALLOON. THE DEVICE WAS REMOVED IN WHOLE, AND THE PROCEDURE WAS COMPLETED WITH A NEW EXPRESS LD STENT. NO PATIENT COMPLICATIONS NOR INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15865230 ↗
• MalfunctionJul 27, 2022Break; Difficult to Open or Remove Packaging Material; Break; Difficult to Open or Remove Packaging Material

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05JUL2022. IT WAS REPORTED THAT DIFFICULTY REMOVAL AND SHAFT BREAK OCCURRED. AN 8.0 X 40 X 135 CM EXPRESS LD ILIAC / BILIARY STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE STENT WAS STUCK IN THE PACKAGING LOOP AND SHAFT BROKE NEAR THE HUB IN THE PACKAGING LOOP WITH FORCE ON TRYING TO DISLODGE. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED SHAFT BREAK 470MM FROM THE DISTAL END OF THE STRAIN RELIEF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15114698 ↗
• MalfunctionJan 7, 2022Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DIFFICULTY REMOVAL AND TIP DETACHMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATE TO SEVERELY CALCIFIED BIFURCATION OF THE RIGHT ILIAC VEIN. AN 8.0X40X135 CM EXPRESS LD STENT WAS ADVANCED FOR TREATMENT. THE BALLOON WAS INFLATED TO 8 ATM FOR 30 SECONDS AND THE STENT WAS DEPLOYED. AFTER THE STENT WAS DEPLOYED, MULTIPLE ATTEMPTS TO PULL NEGATIVE ON THE BALLOON WERE PERFORMED TO ENSURE THE BALLOON WAS DEFLATED. WHEN THE PHYSICIAN PULLED THE CATHETER OUT WITH DIFFICULTY, THE PROXIMAL TIP OF THE BALLOON SNAPPED OFF INSIDE THE SHEATH. THE SHEATH WAS THEN PULLED OUT WITH THE DETACHED PIECES OF THE BALLOON IN IT AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13195056 ↗
• MalfunctionAug 10, 2021Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A 8.0X40X135CM AND A 7.0X60X135CM EXPRESS-B-I LD STENTS WERE ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, BOTH STENTS FAILED TO ADVANCE THROUGH SHEATH. THE PROCEDURE WAS ABORTED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12303628 ↗
• InjuryJul 14, 2021Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT, SHAFT BREAK, AND THROMBOSIS OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED RIGHT COMMON ILIAC ARTERY. AN 8.0X40X135 CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT CAME OFF THE BALLOON AND LODGED INTO THE ANTERIOR TIBIAL ARTERY. THE DISLODGED STENT WAS WEDGED INTO THE ARTERY WHICH CLOTTED OFF. WHILE TRYING TO REMOVE THE DISLODGED STENT FROM THE UNINTENDED ARTERY, THE BALLOON CATHETER BROKE AT THE PROXIMAL BALLOON CONNECTION AND BOTH BALLOON AND STENT REMAINED IN THE BODY. MULTIPLE ATTEMPTS WERE MADE TO REMOVE AND SNARE THE BALLOON AND STENT FROM THE ARTERY BUT FAILED. EVENTUALLY ALL ATTEMPTS WERE CEASED AND THE PROCEDURE WAS TERMINATED.

  Patient problems: Foreign Body In Patient; Thrombosis/Thrombus

  MAUDE report 12167526 ↗
• MalfunctionOct 16, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 8.0X40X135 CM EXPRESS LD STENT WAS OPENED DURING PREPARATION. HOWEVER, THE STENT SLID OFF THE BALLOON AND DISLODGED FROM THE CATHETER WHEN REMOVING THE PROTECTIVE COVER OVER THE STENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10689885 ↗
• InjuryJul 13, 2020Detachment of Device or Device Component; Activation Failure; Detachment of Device or Device Component; Activation Failure

  IT WAS REPORTED THAT DEVICE DETACHMENT OCCURRED. AN 8.0 X 40 X 135 CM EXPRESS LD STENT WAS ADVANCED FOR TREATMENT. HOWEVER, BEFORE REACHING THE NOMINAL PRESSURE, THE STENT DETACHED WITH THE BALLOON. ANOTHER BALLOON WAS USED TO MAKE THE STENT FULLY DEPLOY. THERE WERE NO FURTHER PATIENT COMPLICATIONS NOR INJURIES REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Code Available

  MAUDE report 10264868 ↗
• InjuryAug 21, 2018Device-Device Incompatibility; Device Dislodged or Dislocated; Device-Device Incompatibility; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL VEIN. A 8.0X40X135 CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE PHYSICIAN WANTED TO PERFORM PLAIN OLD BALLOON ANGIOPLASTY (POBA) AGAIN AND THE STENT WAS WITHDRAWN. UPON WITHDRAWAL, THE STENT GOT STUCK IN THE EDGE SHEATH AND DISLODGED. THE STENT WAS REMOVED BY OPEN PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 7801538 ↗
• MalfunctionJun 7, 2018Device Damaged Prior to Use; Device Dislodged or Dislocated; Device Damaged Prior to Use; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION IS LOCATED IN THE ILIAC VESSEL. A 8.0X40X135 CM EXPRESS® LD ILIAC / BILIARY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, AFTER INFLATING THE BALLOON, IT WAS NOTICED THAT THERE WAS NO STENT BEING IMPLANTED. IT WAS THEN FOUND OUT THAT THE STENT WAS DISLODGED IN THE HOOP DURING PREPARATION AND NEVER WENT INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Patient Involvement

  MAUDE report 7579246 ↗