Express® SD Renal/Biliary H74937911715150Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729390435), received between May 23, 2019 and Jun 26, 2026 — classified as 2 injuries, 4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Difficult to Remove

  IT WAS REPORTED THAT THE STENT BALLOON WAS DIFFICULT TO WITHDRAW FROM THE STENT REQUIRING ADDITIONAL INTERVENTION. A 7.0MMX15MMX150CM EXPRESS SD RENAL/BILIARY BALLOON EXPANDABLE STENT WAS USED DURING A RENAL STENTING PROCEDURE. THE 85% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED VESSEL WHICH WAS PRE-DILATED USING A 4X15 BALLOON. THEN THE EXPRESS SD STENT WAS PLACED WITHOUT ANY ISSUES; HOWEVER, THE BALLOON COULD NOT BE RETRACTED THROUGH THE 7FR GUIDE CATHETER AND BECAME STUCK FOR 22 MINUTES. THE PHYSICIAN ACCESSED THE OPPOSITE SIDE, ENGAGED THE DEPLOYED EXPRESS SD STENT AND USED A 2X12 BALLOON TO DETACH THE BALLOON FROM THE STENT STRUTS. THE BALLOON WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND WAS FULLY INTACT WITH NO PART OF THE BALLOON REMAINING IN THE PATIENTS BODY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25638477 ↗
• MalfunctionSep 23, 2024Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT DIFFICULTY REMOVING THE STENT OCCURRED. AN EXISTING STENT WAS IN PLACE WITH HIGH GRADE STENOSIS. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY AND WAS PRE-DILATED WITH A 6X20 .018 NON-BSC BALLOON FOR 1 MINUTE. FOLLOWING EXCHANGE OF V-18 GUIDEWIRE FOR AN AMPLATZ, A SHEATH WAS ADVANCED THROUGH THE EXISTING STENT. A 7.0MMX15MMX150CM EXPRESS SD STENT BALLOON WAS SENT THROUGH THE SHEATH AND THE BALLOON INFLATED TO 14 ATMOSPHERES FOR 1 MINUTE. HOWEVER, AFTER DEFLATION, THE BALLOON WOULD NOT WITHDRAW. THERE WAS NO KINK OR TWIST IN THE SHEATH, AND THE WIRE HAD TO BE PULLED TO WITHDRAW THE BALLOON. UPON VISUAL INSPECTION, IT APPEARED THAT THE BALLOON DID NOT REWRAP. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20280731 ↗
• MalfunctionFeb 6, 2024Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. THE TARGET LOCATION WAS LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS RENAL ARTERY. TWO STENTS WERE USED IN THE LEFT RENAL ARTERY AND ONE IN THE RIGHT RENAL ARTERY. A 7.0MMX15MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INSERTION, THE DISTAL PART OF THE SHAFT BROKE IN THE SHEATH. THE DEVICE WAS PULLED OUT INTACT, AND THE PROCEDURE WAS COMPLETED WITH A NEW EXPRESS SD RENAL/BILIARY STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18649145 ↗
• MalfunctionApr 10, 2023Fracture; Migration; Fracture; Migration

  IT WAS REPORTED THAT STENT FRACTURE AND MIGRATION OCCURRED. A 7.0MMX15MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS IMPLANTED IN THE CELIAC ARTERY ON (B)(6) 2022. HOWEVER, DURING THE ROUTINE CT FOLLOW-UP OF THE PATIENT, IT WAS REVEALED THE STENT HAD BROKEN. A PIECE OF THE BROKEN STENT HAD MIGRATED TO THE DISTAL AORTA/BIFURCATION. THE PHYSICIAN WAS UNAWARE OF WHEN WAS THE STENT BROKE OFF AND MIGRATED AND DOES NOT HAVE A PLAN TO REMOVE THE STENT AND RE-STENT THE CELIAC ARTERY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 16709514 ↗
• MalfunctionJan 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED FROM THE BALLOON. A 7.0MMX15MMX150CM EXPRESS SD BALLOON EXPANDABLE STENT WAS SELECTED FOR USE TO TREAT PERIPHERAL ARTERY DISEASE (PAD). THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY AND WAS NOTED AS MILDLY CALCIFIED. THE STENT DELIVERY SYSTEM WAS ADVANCED TO THE TARGET LESION. HOWEVER, THE STENT DISLODGED FROM THE BALLOON PREMATURELY AND DEPLOYED IN AN UNINTENDED LOCATION. THE STENT WAS NOT REMOVED. A NEW EXPRESS SD STENT WAS USED AND IMPLANTED IN THE CORRECT LOCATION. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13155797 ↗
• InjuryMay 23, 2019Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT THE STENT DISLODGED. THE TARGET LESION WAS LOCATED IN A RENAL ARTERY. A 7.0MMX15MMX150CM EXPRESS SD STENT WAS ADVANCED FOR TREATMENT WITH A 6FR GUIDE CATHETER. DURING PROCEDURE, THE STENT WAS UNABLE TO CROSS THE LESION AND THE STENT CAME OFF THE BALLOON AND LANDED IN EXTERNAL ILIAC ARTERY. THE STENT WAS DEPLOYED TO 7.5MM SO IT WOULD BE OPPOSED TO THE VESSEL WALL INSTEAD OF TRYING TO RETRIEVE IT. A 5MM BALLOON WAS USED TO PRE-DILATE THE RENAL ARTERY AND ANOTHER STENT WAS SUCCESSFULLY DEPLOYED IN THE TARGET LESION WITH THE USED OF A GUIDE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8636959 ↗