Express® SD Renal/Biliary H74937912519150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729390473), received between Jan 22, 2025 and Sep 3, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND NON-CALCIFIED PULMONARY VESSEL. A 5.0MMX19MMX150CM EXPRESS SD STENT BALLOON EXPANDABLE WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING THE PROCEDURE, THE SHAFT OF THE STENT WAS SNAPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955330 ↗
• InjuryJan 27, 2025Entrapment of Device; Fracture; Entrapment of Device; Fracture

  IT WAS REPORTED THAT THE WIRE BECAME WRAPPED WITH THE STENT AND BROKE OFF, REQUIRING SNARE FOR REMOVAL. A 5.0MMX19MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS SELECTED FOR MESENTERIC STENTING. HOWEVER, DURING DEPLOYMENT, IT WAS NOTED THAT THE STENT AND WIRE BECAME WRAPPED AND BROKE OFF. THE BROKEN PIECES OF THE STENT AND WIRE WERE SNARED OUT AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21246306 ↗
• MalfunctionJan 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 5.0MMX19MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS USED IN THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT STRUT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207957 ↗