Express® SD Renal/Biliary H74937911614900Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729484837), received between Aug 29, 2019 and Aug 2, 2021 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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.

• InjuryAug 2, 2021Break; Device Dislodged or Dislocated; Break; Device Dislodged or Dislocated

  IT WAS REPORTED THAT SHAFT BREAK, STENT DISLODGEMENT OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED ILIAC VEIN. A 6.0MMX14MMX90CM EXPRESS SD STENT WAS ADVANCED BUT THE SHAFT BROKE AND LOST PUSH ABILITY. DURING REMOVAL, THE STENT CAME OFF THE CATHETER. THE PHYSICIAN THEN USED AN OPTICROSS 18 INTRAVASCULAR ULTRASOUND (IVUS) TO LOOK ON THE STENT BUT THE IVUS GOT STUCK IN THE LESION AND THE SCREEN WENT BLACK. SUBSEQUENTLY, A 7.0MMX15MMX90CM EXPRESS SD STENT WAS USED TO TACK UP THE SMALLER STENT BUT IT ALSO BROKE DURING DEPLOYMENT AND HAD TO BE REMOVED. THE PROCEDURE WAS COMPLETED USING ADDITIONAL SD STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12260323 ↗
• MalfunctionNov 6, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED RENAL ARTERY. A 6.0MMX14MMX90CM EXPRESS SD STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING INFLATION TO DEPLOY THE STENT, THE BALLOON RUPTURED. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10804755 ↗
• InjuryApr 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE TOUGH TORTUOUS RENAL ARTERY. A 6.0MM X 14MM X 90CM EXPRESS SD STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING DEPLOYMENT, THE STENT CAME OFF THE DELIVERY BALLOON. IT WAS RECOVERED AND WAS DEPLOYED IN THE EXTERNAL ILIAC AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT'S STATUS WAS GOOD.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9957199 ↗
• MalfunctionAug 29, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. DURING PREPARATION OF A 6.0MMX14MMX90CM EXPRESS SD RENAL/BILIARY STENT, THE PHYSICIAN REMOVED THE PLASTIC COVERING THAT WAS ON TOP OF THE STENT AND AT THE SAME TIME THE STENT CAME WITH IT. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME DEVICE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8943973 ↗