Express® SD Renal/Biliary H74937911515150Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729390398), received between Jan 8, 2019 and Dec 19, 2023 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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.

• InjuryDec 19, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED VIA MEDWATCH MW5148098 THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT RENAL ARTERY. A 5.0MMX15MMX150CM EXPRESS SD STENT WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE STENT DISLODGED FROM THE BALLOON CATHETER. THE GUIDE SHEATH WAS USED TO CAPTURE AND THEN DEPLOY THE STENT INTO THE RIGHT ILIAC ARTERY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18357708 ↗
• MalfunctionMay 6, 2022Contamination; Contamination

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 5.0MMX15MMX150CM EXPRESS SD STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE STERILE SCRUBBED GLOVE WAS TORN AND CAUGHT ONTO THE STENT UPON REMOVING IT FROM THE HOOP OF THE STERILE PACKAGING. SO THE STENT HAD TO BE REMOVED FROM THE FIELD, THE CONTAMINATED GLOVES WERE REMOVED AND REPLACED WITH A NEW ONE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14310680 ↗
• InjuryApr 14, 2022Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED VERTEBRAL ARTERY. A 5.0MM X 15MM X 150CM EXPRESS SD RENAL/BILIARY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING INITIAL INFLATION AT 6 ATMOSPHERES, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITH A SNARE AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14116204 ↗
• MalfunctionAug 20, 2020Difficult to Advance; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 5.0MMX15MMX150CM EXPRESS SD STENT WAS ADVANCED FOR TREATMENT BUT COULD NOT GET THROUGH FROM AORTA TO THE RIGHT PLACE AS THE CURVE WAS TOO BIG. IT WAS NOTED THAT THE CATHETER FRENCH WAS TOO STIFF. THE DEVICE WAS PULLED OUT IMMEDIATELY AND THERE WERE NO TRAUMA TO ANY TISSUE OCCURRED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10431397 ↗
• MalfunctionFeb 21, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE VERTEBRAL ARTERY. A 5.0MMX15MMX150CM EXPRESS SD STENT WAS SELECTED FOR USE. WHEN THE RADIOLOGIST TRIED TO INSERT THE DEVICE INTO THE WIRE, BENT STENT STRUT WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9740717 ↗
• InjuryJan 8, 2019Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISSECTION OCCURRED. A 7FR 100CM GUIDE CATHETER AND 200CM V18 GUIDEWIRE WERE USED TO ACCESS THE LESION IN THE STENOSED LEFT RENAL ARTERY. PRE-DILATION WAS PERFORMED. A 5.0MMX15MMX150CM EXPRESS SD RENAL/BILIARY AND 6.0MMX18MMX150CM EXPRESS SD RENAL/BILIARY WERE SELECTED FOR USE BUT FAILED TO CROSS THE STENOSIS AFTER MULTIPLE ATTEMPTS TO BE PLACED AT THE TARGET SITE DUE TO THE ANGLED RENAL ARTERY. A DISSECTION OCCURRED AT THE ENTRY OF THE LEFT RENAL ARTERY. ANGIOPLASTY WAS PERFORMED TO ASSURE NORMAL BLOOD FLOW. THE PATIENT WAS PLACED UNDER OBSERVATION AND RESCHEDULED FOR ANOTHER RENAL ARTERY STENTING PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 8228453 ↗