Express® SD Renal/Biliary H74937911614150Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729484820), received between May 24, 2019 and Jun 25, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Activation Failure

  IT WAS REPORTED THAT STENT FAILURE TO EXPAND OCCURRED. THE TARGET LESION WAS LOCATED IN THE VERY TORTUOUS AND TIGHT SUPERIOR MESENTERIC ARTERY. A 6.0MMX14MMX150CM EXPRESS SD RENAL/BILIARY WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS NOT FULLY EXPANDED IN THE LESION. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25627571 ↗
• InjuryApr 27, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED REQUIRING ADDITIONAL INTERVENTION. A 6.0MM X 14MM X 150 CM EXPRESS SD STENT WAS SELECTED FOR USE IN A RENAL STENTING PROCEDURE. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. DURING THE PROCEDURE, AFTER THE STENT WAS DEPLOYED, THE BALLOON GOT STUCK IN THE STENT. THE PHYSICIAN WAS ABLE TO REMOVE THE BALLOON FROM THE STENT, WITH GREAT DIFFICULTY. AFTER THE BALLOON WAS REMOVED FROM THE DEPLOYED STENT, THE BALLOON WOULD NOT COME BACK THROUGH THE SHEATH. AT THAT TIME THE PHYSICIAN THOUGHT THE BALLOON MAY STILL BE INFLATED. THUS, THE BACK END OF A NON-BOSTON SCIENTIFIC GUIDEWIRE WAS USED, THROUGH THE SHEATH, TO TRY AND RUPTURE THE BALLOON. THIS DID NOT WORK. AFTER TRYING FOR AN HOUR AND A HALF, THE BALLOON WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED, AND NO PATIENT COMPLICATIONS WERE REPORTED. AFTER REMOVAL FROM THE PATIENT, THE BALLOON WAS ABLE TO INFLATE AND DEFLATE AS IT SHOULD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16828590 ↗
• MalfunctionAug 30, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT BALLOON REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. PRE- DILATATION WITH A 4X20MM BALLOON WAS PERFORMED AT 8 AND 14 ATMOSPHERES. A 6.0MMX14MMX150CM EXPRESS SD RENAL/BILIARY STENT CATHETER WAS ADVANCED FOR TREATMENT. THE STENT WAS PLACED USING A V18 WIRE AT 10 ATMOSPHERES. HOWEVER, THE PHYSICIAN HAD DIFFICULTY REMOVING THE BALLOON SHAFT. THE DEVICE WAS CHALLENGING TO REMOVE AND TOOK 20 MINUTES, WHILE THE SHEATH AND WIRE WERE REMOVED EASILY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12388694 ↗
• MalfunctionMay 24, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED. THE 60-70% STENOSED TARGET LESION WAS LOCATED IN A CELIAC ARTERY. A 6.0MMX14MMX150CM EXPRESS SD STENT WAS ADVANCED FOR TREATMENT USING A 7FR IM GUIDE CATHETER AND A .018 GUIDEWIRE. HOWEVER, DURING PROCEDURE, IT FAILED TO CROSS THE LESION. THE PHYSICIAN ATTEMPTED TO PULL THE STENT BACK INTO THE GUIDE CATHETER, BUT IT WOULD NOT GO BACK. IT WAS THEN ATTEMPTED TO REMOVE THE WHOLE SYSTEM BUT THE STENT CAME OFF OF THE BALLOON. A SNARE WAS USED TO REMOVE THE STENT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8640258 ↗