Express® LD Iliac / Biliary H74938046740750Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729392217), received between May 24, 2017 and Sep 29, 2026 — classified as 8 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933982 ↗
• MalfunctionFeb 19, 2026Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 7.0 X 40 X 75 CM EXPRESS LD STENT BALLOON WAS SELECTED FOR USE. UPON PREPARATION, IT WAS OBSERVED THAT THE STENT WAS NOT MOUNTED ON THE BALLOON PRIOR TO USE, AND STENT DAMAGE WAS NOTED. THE AFFECTED DEVICE WAS NOT USED FOR TREATMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388565 ↗
• MalfunctionDec 21, 2023Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem

  IT WAS REPORTED THAT THE STENT WAS DETACHED FROM THE BALLOON. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY. A 7.0X40X75CM EXPRESS LD STENT BALLOON EXPANDABLE CATHETER WAS ADVANCED FOR TREATMENT. THE STENT WAS INSERTED INTO THE SHEATH; HOWEVER, THE DEVICE COULD NOT GET IT INTO CORRECT PLACEMENT. WHEN ATTEMPTING TO PUSH THE SHEATH OVER THE STENT TO REPOSITION, IT APPEARED THAT THE STENT WAS DETACHED FROM THE BALLOON. THE BALLOON AND THE STENT WERE PULLED BACK INTO THE SHEATH AND WERE REMOVED SUCCESSFULLY WITHOUT ANY ISSUE. UPON REMOVAL, IT WAS CONFIRMED THAT THE STENT WAS DETACHED FROM THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A NEW EXPRESS LD STENT. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18380355 ↗
• MalfunctionJan 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 7.0X40X75CM EXPRESS LD ILIAC / BILIARY STENT WAS SELECTED FOR USE. HOWEVER, THE STENT WAS FOUND ON THE BACK TABLE OFF OF THE BALLOON PRIOR TO PUTTING INTO THE PATIENT. ANOTHER EXPRESS LD STENT WAS USED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE STENT WAS FOUND DETACHED FROM THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16147646 ↗
• InjuryOct 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT AND HEMATOMA OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDY CALCIFIED RIGHT COMMON ILIAC ARTERY. A 7.0X40X75 CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT CAME OFF THE BALLOON WHEN IT WAS ADVANCED OUTSIDE THE SHEATH. THE DEVICE WAS SNARED OUT AND ANOTHER STENT WAS PLACED SUCCESSFULLY. THE SHEATH HAD TO BE PULLED OUT AND WAS UNABLE TO USE A CLOSURE DEVICE. THE PATIENT WAS NOTED TO DEVELOP A HEMATOMA IN THE GROIN AND HAD TO BE TRANSFERRED TO AN EMERGENCY ROOM. NO FURTHER INTERVENTION WAS REQUIRED, AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S STATUS WAS GOOD.

  Patient problems: Hematoma

  MAUDE report 15665895 ↗
• InjuryMar 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN MILDLY TORTUOUS AND SEVERELY CALCIFIED LEFT ILIAC ARTERY. AFTER A LONG SHEATH WAS INSERTED, A 7.0X40X75CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN THE DEVICE WAS PULLED BACK, THE STENT CAME OFF THE BALLOON DELIVERY SYSTEM IN THE AORTA. THE PHYSICIAN WAS ABLE TO SNEAK A BALLOON THROUGH THE LUMEN OF THE DISLODGED STENT, INFLATE THE BALLOON TO LOW ATMOSPHERES AND BRING THE STENT BACK TO THE COMMON ILIAC WHERE IT WAS THEN DEPLOYED IN THE CORRECT SPOT. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694284 ↗
• InjuryJul 6, 2021Detachment of Device or Device Component; Migration; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT DEVICE MIGRATION AND SURGICAL INTERVENTION OCCURRED. THE TARGET LESION WAS LOCATED IN ARTERIAL ILIOFEMORAL. A 7.0X40X75CM EXPRESS-B-I LD STENT WAS IMPLANTED. HOWEVER, DEVICE MIGRATION OCCURRED AND SURGICAL FEMORAL CUT DOWN WAS PERFORMED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FULLLY RECOVERED. IT WAS FURTHER REPORTED VIA MEDWATCH (B)(4), THAT THE CATHETER WAS WITHIN THE LEFT COMMON FEMORAL ARTERY. WHEN IT WAS PULLED BACK, THE CATHETER TIP DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12122632 ↗
• MalfunctionAug 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT COMMON ILIAC ARTERY. A 7.0X40X75CM EXPRESS LD STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE STENT WAS ADVANCED ON THE WIRE INTO THE SHEATH, IT WOULD NOT ENTER AND NOTICED THAT THE STENT WAS OFF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10356307 ↗
• InjuryMay 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE HIGHLY CALCIFIED ILIAC ARTERY. A 7.0X40X75CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING ADVANCING, THE STENT CAME OFF FROM THE BALLOON. THE STENT WAS ONLY HALF WAY ACROSS LESION BUT THE PHYSICIAN DECIDED TO DEPLOY THE STENT WHERE IT WAS. AN ADDITIONAL 7X27 EXPRESS STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10065485 ↗
• MalfunctionApr 23, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED. A 7.0X40X75CM EXPRESS LD ILIAC STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, WHEN THE BALLOON WAS INFLATED, IT WAS DISLODGED A LITTLE AND PART OF THE STENT DID NOT DEPLOYED. THE BALLOON STENT WAS DEFLATED AND THEN INFLATED AGAIN BACK THROUGH THE STENT. THE STENT WAS DEPLOYED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9991435 ↗
• MalfunctionFeb 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 7.0X40X75CM EXPRESS LD STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION IT WAS FOUND OUT THAT STENT WAS AT THE PROXIMAL PART OF THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9734626 ↗
• InjuryApr 29, 2019Device Dislodged or Dislocated; Activation Failure; Device Dislodged or Dislocated; Activation Failure

  IT WAS REPORTED THAT STENT DISLODGED INSIDE THE PATIENT. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND VERY TIGHT PROXIMAL EXTERNAL RIGHT ILIAC. A RIGHT SIDED PUNCTURE WAS PERFORMED AND STAYED TRUE LUMEN BY USING A 6FR NON-BSC SHEATH. A 7.0X40X75CM EXPRESS LD ILIAC / BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, WHEN THE PHYSICIAN ADVANCED THE EXPRESS LD STENT DELIVERY SYSTEM OUT THROUGH THE SHEATH, IT WAS NOTED THAT THE STENT IMMEDIATELY FELL OFF THE DELIVERY SYSTEM. ONLY THE BALLOON CATHETER ADVANCED WHILE THE STENT REMAINED JUST OUTSIDE THE SHEATH. THE PHYSICIAN THEN USED A 4FR NON-BSC CATHETER TO PUSH THE STENT ACROSS THE STENOSIS AND WAS ABLE TO INFLATE A 4MM MUSTANG BALLOON TO PARTIALLY EXPAND THE STENT. POST DILATION WAS THEN PERFORMED WITH THE 7MM EXPRESS LD BALLOON CATHETER. THE RESULT WAS NOT OPTIMAL, SO THE PHYSICIAN USED A NON-BSC COVERED STENT ACROSS A SEGMENT OF STENOSIS THAT WAS NOT COVERED BY THE EXPRESS LD STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8561104 ↗
• InjuryMay 29, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT STENT MIGRATION OCCURRED. VASCULAR ACCESS WAS OBTAINED UTILIZING BILATERAL ACCESS. THE 60% STENOSED TARGET LESIONS WERE LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED LEFT AND RIGHT ILIAC ARTERIES. AN 8.0 X 40 X 75 CM EXPRESS® LD ILIAC / BILIARY STENT WAS DEPLOYED IN THE RIGHT ILIAC ARTERY AND A 7.0 X 40 X 75 CM EXPRESS® LD ILIAC / BILIARY STENT WAS DEPLOYED IN THE LEFT ILIAC ARTERY. ANGIOGRAPHY WAS PERFORMED, HOWEVER, IT WAS NOTED THAT THERE WAS NO STENT IN THE LEFT ILIAC ARTERY. SUBSEQUENT ANGIOGRAPHY REVEALED THAT THE 7.0 X 40 X 75 CM STENT HAD MIGRATED INTO THE LOWER AORTA. A 35 GUIDE WIRE WAS THEN PLACED THROUGH THE MIGRATED STENT. A 20 MM NON-BSC SNARE RETRIEVAL KIT WAS USED THROUGH THE RIGHT ILIAC ARTERY TO FIXATE THE GUIDE WIRE AND TO PREVENT FURTHER MIGRATION. A 9 X 60 MM NON-BSC BALLOON CATHETER WAS THEN INFLATED AND THE STENT WAS PULLED BACK INTO THE LEFT ILIAC ARTERY. A 10 X 60 MM NON-BSC BALLOON CATHETER WAS THEN INFLATED TO FURTHER APPOSE THE STENT. A 10 X 60 MM NON-BSC STENT WAS INSERTED INTO THE 7.0 X 40 X 75 CM EXPRESS® LD ILIAC / BILIARY STENT TO EXTEND LENGTH AND ENSURE FULL APPOSITION AND WAS FOLLOWED BY DILATION WITH A 10X60 NON-BSC B

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7550047 ↗
• MalfunctionFeb 22, 2018Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THE LABEL WAS INCORRECT. AN EXPRESS® LD ILIAC / BILIARY STENT WAS SELECTED FOR A BILATERAL ILIAC STENTING PROCEDURE ON (B)(6) 2018. IT WAS LATER FOUND THAT THERE WAS INCORRECT LABELING WHEN THE DEVICE WAS ATTEMPTED TO BE ENTERED INTO THE CUSTOMERS COSTING AND TRACKING DATA SYSTEM. THE FOLLOWING INFORMATION WAS LISTED ON THE LABEL: UPN: (B)(4); SIZE: 7MM X 37MM 75CM; GTIN: (B)(4); BATCH: 21026004. THE UPN AND SIZE LISTED WERE FOUND TO BE INACCURATE FOR THE LABELED BATCH AS THE LABELED BATCH IS ASSOCIATED WITH UPN (B)(4) AND SIZE 7MM X 40MM 75CM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7290236 ↗
• MalfunctionOct 5, 2017Bent; Device Damaged by Another Device; Bent; Device Damaged by Another Device

  SAME CASE AS MDR ID 2134265-2017-09837. IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT ILIAC ARTERY. A 7.0X40X75CM EXPRESS® LD STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND WAS ADVANCED AGAIN THROUGH THE SHEATH. HOWEVER, RESISTANCE WAS ENCOUNTERED UPON ADVANCING AND IT WAS NOTED THAT THE STENT STRUTS WAS BENT UP. SUBSEQUENTLY, ANOTHER 7.0X40X75CM EXPRESS® LD STENT WAS ADVANCED FOR TREATMENT; MOREOVER, THE STENT SLIPPED OFF FROM THE BALLOON IN THE LEFT ILIAC ARTERY. THE STENT WAS PUSHED OVER THE BIFURCATION AND ACROSS THE LESION IN THE RIGHT COMMON ILIAC ARTERY AND WAS OPENED BY A DIFFERENT BALLOON CATHETER. 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 6917795 ↗
• InjuryOct 5, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SAME CASE AS MDR ID 2134265-2017-09926. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT ILIAC ARTERY. A 7.0X40X75CM EXPRESS® LD STENT WAS ADVANCED BUT FAILED TO CROSS THE LESION. THE DEVICE WAS REMOVED AND WAS ADVANCED AGAIN THROUGH THE SHEATH. HOWEVER, RESISTANCE WAS ENCOUNTERED UPON ADVANCING AND IT WAS NOTED THAT THE STENT STRUT WAS BENT UP. SUBSEQUENTLY, ANOTHER 7.0X40X75CM EXPRESS® LD STENT WAS ADVANCED FOR TREATMENT; MOREOVER, THE STENT SLIPPED OFF FROM THE BALLOON IN THE LEFT ILIAC ARTERY. THE STENT WAS PUSHED OVER THE BIFURCATION AND ACROSS THE LESION IN THE RIGHT COMMON ILIAC ARTERY AND WAS OPENED BY A DIFFERENT BALLOON CATHETER. 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 6917700 ↗
• InjuryMay 24, 2017Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT PREMATURE DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ILIAC VEIN. A 7.0X40X75CM EXPRESS® LD ILIAC / BILIARY WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE STENT WAS ACCIDENTALLY DEPLOYED IN THE SHEATH. THE WHOLE SYSTEM WAS REMOVED AND PHYSICIAN DECIDED TO AN OPEN REPAIR INSTEAD. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6587072 ↗