Express® LD Iliac / Biliary H74938046840750Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729392279), received between Sep 17, 2018 and Jan 28, 2026 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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.

• MalfunctionJan 28, 2026Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC ARTERY. THE LESION WAS PREDILATED. AN 8.0 X 40 X 75 CM EXPRESS LD ILIAC/BILIARY BALLOON-EXPANDABLE STENT WAS ADVANCED FOR TREATMENT. WHILE ATTEMPTING TO ADVANCE THE DEVICE THROUGH THE LESION, THE STENT CAME OFF FROM THE BALLOON. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS RESULTING FROM THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24200222 ↗
• InjuryMar 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT FELL OFF THE BALLOON PRIOR TO DEPLOYMENT. AN 8.0MM X 40MM X 75CM EXPRESS LD PREMOUNTED STENT SYSTEM WAS ADVANCED FOR USE IN THE STENOSED SUBCLAVIAN ARTERY. IT WAS THEN DECIDED TO REMOVE THE DEVICE AND PREDILATE AGAIN. UPON REMOVAL OF THE DEVICE, IT WAS OBSERVED THAT THE STENT HAD FALLEN OFF THE BALLOON IN THE SUBCLAVIAN ARTERY. A 4.0 X 40 MM BALLOON WAS ABLE TO BE THREADED INTO THE STENT, AND THE STENT WAS DEPLOYED IN THE RADIAL ARTERY. THE PROCEDURE WAS COMPLETED, AND THE PATIENT WAS EXPECTED TO FULLY RECOVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21541078 ↗
• InjuryOct 31, 2024Entrapment of Device; Difficult to Advance; Device Dislodged or Dislocated; Entrapment of Device; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED, REQUIRING AN ADDITIONAL STENT. THE 85% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED COMMON ILIAC ARTERY (CIA). AN 8.0X40X75CM EXPRESS LD STENT WAS SELECTED FOR PERIPHERAL ANGIOGRAM WITH STENTING. DURING THE PROCEDURE, IT WAS HARD TO ADVANCE THE STENT INTO THE TARGET LESION. THE STENT CATHETER WAS THEN ATTEMPTED TO BE REMOVED TO EXCHANGE FOR A STIFFER WIRE. HOWEVER, IT WAS NOTED THAT THE STENT CAME OFF THE BALLOON CATHETER AND WAS LEFT ON THE CURRENT WIRE IN PLACE. MULTIPLE ATTEMPTS WERE MADE TO SNARE THE UNDEPLOYED STENT WHICH WERE NOT SUCCESSFUL. IT WAS THEN DECIDED TO JAIL THE STENT WITH ANOTHER EXPRESS LD IN THE EXTERNAL ILIAC ARTERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20579320 ↗
• InjuryMar 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED, REQUIRING AN ADDITIONAL DEVICE. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED ILIAC AND RENAL ARTERIES. FOLLOWING PRE-DILATATION WITH A 6.0 X 80, 135CM MUSTANG BALLOON CATHETER AND PLACING A NEW 7F NON-BOSTON SCIENTIFIC SHEATH, A 8.0X40X75CM EXPRESS LD STENT WAS SELECTED FOR USE. HOWEVER, WHEN THE EXPRESS LD WENT OVER THE BIFURCATION AND WAS JUST ABOUT TO BE PLACED OVER THE LESION, THE STENT DISLODGED. THE PHYSICIAN DECIDED TO LEAVE THE STENT AND DEPLOYED IT USING A NEW MUSTANG BALLOON CATHETER. ANOTHER EXPRESS LD STENT WAS USED TO COVER THE REMAINDER OF THE LESION. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS SCHEDULED FOR FOLLOW-UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18845561 ↗
• InjuryDec 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE COMMON ILIAC ARTERY. AN 8.0X40X75CM EXPRESS LD STENT WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE STENT CAME OFF FROM THE BALLOON PRIOR TO DEPLOYMENT. AN 8 X 60 X 130 INNOVA VASCULAR STENT WAS USED TO TRAP THE EXPRESS LD STENT UP AGAINST THE WALL VESSEL. HOWEVER, THE INNOVA STENT DID NOT REACH THE DESIRED TARGET AREA FOR PLACEMENT. THE PHYSICIAN PLANS TO SEND BACK THE PATIENT TO STENT THE INTENDED AREA. NO COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18360738 ↗
• MalfunctionFeb 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. AN 8.0X40X75CM EXPRESS LD ILIAC / BILIARY STENT WAS SELECTED FOR USE. HOWEVER, DURING PREPARATION, THE STENT WAS DISLODGED OFF BALLOON AND WAS FOUND ON BACK TABLE PRIOR TO PATIENT IMPLANT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16432746 ↗
• InjuryNov 4, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ILIAC ARTERY. A 8.0X40X75CM EXPRESS LD STENT WAS ADVANCED FOR TREATMENT. HOWEVER, WHEN ADVANCING TO THE LESION, THE STENT PARTIALLY DEPLOYED. THE PHYSICIAN HAD TO DEPLOY THE STENT ABOVE THE LESION. SUBSEQUENTLY, ANOTHER STENT WAS OPENED AND DEPLOYED IN THE LESION AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15734079 ↗
• InjuryMar 18, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS ILIAC ARTERY. A 8.0X40X75CM EXPRESS LD STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT DISLODGED INSIDE PATIENT. IT WAS RETRIEVED THROUGH SNARING AND WAS COMPLETELY REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11516258 ↗
• MalfunctionSep 15, 2020Entrapment of Device; Material Integrity Problem; Entrapment of Device; Material Integrity Problem

  IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE COMMON ILIAC VESSEL. AN 8.0X40X75CM EXPRESS LD STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, THE DEVICE BECAME STUCK WITH THE WIRE. BOTH DEVICES WERE REMOVED TOGETHER FROM THE PATIENT'S BODY. THE WIRE WOULD NOT RETRACT FROM THE LUMEN UNTIL PULLED FORCEFULLY AFTER REMOVAL FROM THE BODY. IT WAS NOTICED THAT THE CATHETER OF THE STENT LOOKED ODDLY DISCOLORED AND THINNED. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPRESS LD STENT WITH A DIFFERENT GUIDE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10536585 ↗
• InjuryAug 24, 2020Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES AND STENT DISLODGEMENT OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED AT THE RIGHT ILIAC VEIN. A 8.0X40X75CM EXPRESS LD STENT WAS ADVANCED FOR TREATMENT. A PICTURE WAS TAKEN BUT COULD NOT SEE THE VESSEL WELL, SO THE STENT WAS PULLED BACK; HOWEVER, RESISTANCE WAS FELT. DURING FLUOROSCOPY, IT WAS NOTICED THAT THE STENT CAME OFF OF THE BALLOON. THE SHEATH, BALLOON AND STENT WERE PULLED BACK IN ONE UNIT. THE SHEATH AND BALLOON WERE OUT OF THE BODY AND IT WAS NOTED THAT THE STENT WAS LEFT IN THE FEMORAL ARTERY RIGHT AT THE ACCESS SITE. ADDITIONAL LIDOCAINE WAS GIVEN, AND A SMALL NICK WAS MADE IN THE SKIN TO PULL THE STENT OUT USING THE HEMOSTAT. THE PROCEDURE WAS CONTINUED AND A NEW SHEATH WAS INSERTED IN THE LEFT FEMORAL ARTERY. A NEW STENT WAS ADVANCED AND DEPLOYED WITHOUT COMPLICATIONS. THE PATIENT WAS STABLE DURING THE WHOLE PROCEDURE AND WAS SENT TO RECOVERY AFTER. THE PATIENT WAS DISCHARGED ON THE SAME DAY.

  Patient problems: No Code Available

  MAUDE report 10442933 ↗
• InjuryJul 19, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT ILIAC VESSEL. A 8.0X40X75CM EXPRESS LD ILIAC / BILIARY WAS ADVANCED TO TREAT THE LESION. HOWEVER, WHEN THE PHYSICIAN PULLED BACK THE DEVICE FOR STENT PLACEMENT, THE STENT CAME OFF OF THE BALLOON. ALL DEVICES WERE REMOVED AND THE STENT WAS SUCCESSFULLY REMOVED FROM ACCESS SITE. THE PROCEDURE WAS COMPLETED WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8808085 ↗
• InjurySep 17, 2018Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT AND REMOVAL DIFFICULTIES OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT LOWER EXTREMITY. AFTER A 6F INTRODUCER SHEATH WAS INTRODUCED IN THE LESION, AN 8.0X40X75CM EXPRESS LD STENT WAS ADVANCED INTO THE SHEATH; HOWEVER, WHEN THE PHYSICIAN PUSHED THE STENT, IT SLIPPED OFF THE BALLOON. WHEN THE PHYSICIAN TRIED TO REMOVE THE DEVICE OUT OF THE SHEATH, THE STENT BECAME STUCK IN THE SHEATH. AN ALLIGATOR FORCEPS WAS USED TO COMPLETELY REMOVE THE STENT OUT OF THE PATIENT'S BODY AND THE PROCEDURE WAS ENDED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE, JUST A SORE GROIN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7881390 ↗