Express® SD Renal/Biliary H74937912519900Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729390480), received between Nov 25, 2019 and Jul 5, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2022Positioning Failure; Failure to Advance; Material Deformation; Positioning Failure; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 5.0MMX19MMX90CM EXPRESS SD RENAL/BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT FAILED TO CROSS THE LESION AND WAS UNABLE TO DEPLOY. WHEN THE DEVICE WAS REMOVED, THE DISTAL END OF THE STENT STRUT WAS FOUND TO BE LIFTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14917528 ↗
• InjuryMar 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 5.0MMX19MMX90CM EXPRESS SD RENAL/BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE THE STENT CAME OFF THE BALLOON BEFORE IT WAS DEPLOYED. THE PHYSICIAN REMOVED THE STENT WITH A RETRIEVAL DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9793760 ↗
• InjuryNov 25, 2019Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT RENAL ARTERY. A 5.0MMX19MMX90CM EXPRESS SD RENAL/BILIARY DRUG-ELUTING STENT WAS ADVANCED THROUGH A TIGHT STENOSIS. THE STENT WOULD NOT ADVANCE THROUGH THE TIGHT STENOSIS. THE DEVICE WAS BEING REMOVED, IT WAS NOTED DURING REMOVAL THAT THE STENT CAME OFF THE BALLOON. THE DISLODGED STENT WAS SNARED OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9371163 ↗