Express® SD Renal/Biliary H74937912719900Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729390527), received between Sep 21, 2018 and Dec 11, 2025 — classified as 2 injuries, 4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Break; Difficult to Remove; Failure to Deflate; Break; Difficult to Remove; Failure to Deflate

  IT WAS REPORTED THAT FAILURE TO DEFLATE OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE SUPERIOR MESENTERIC ARTERY (SMA). A 7.0MM X 19MM X 90CM EXPRESS SD RENAL/BILIARY WAS SELECTED FOR USE. DURING THE PROCEDURE, A 6F GUIDE CATHETER AND A .14 GUIDEWIRE WERE INSERTED INTO THE ARTERY. THE EXPRESS STENT WAS ADVANCED INTO THE SMA AND THE GUIDE SHEATH WAS RETRACTED BACK. THE BALLOON WAS INFLATED TO NOMINAL PRESSURE AND COMPLETELY DEFLATED AFTER THREE MINUTES. DURING AN ATTEMPT TO REMOVE THE BALLOON, RESISTANCE WAS MET. FORCE WAS APPLIED, CAUSING THE BALLOON SHAFT TO BREAK. THE BALLOON AND SHAFT WERE SUCCESSFULLY RETRIEVED OUT OF THE SHEATH WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23783444 ↗
• InjuryAug 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED, THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED LESION. A 7.0MMX19MMX90CM EXPRESS SD RENAL/BILIARY WAS USED, HOWEVER, DURING THE PROCEDURE THE STENT WAS PLACED INSIDE THE PATIENT AND PRIOR TO REACHING THE LESION THE STENT CAME OFF THE SHAFT/BALLOON AND HAD TO BE RETRIEVED WITH A SNARE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17515264 ↗
• InjuryMar 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT CAME OFF THE BALLOON. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERIOR MESENTERIC ARTERY. A 7.0MMX19MMX90CM EXPRESS SD RENAL/BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT CAME OFF THE BALLOON WHILE TRYING TO CROSS THE LESION. THE STENT HAD TO BE SNARED AND WAS PULLED OUT THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13776511 ↗
• MalfunctionSep 1, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT STENT PROFILE PROBLEM OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED RENAL ARTERY. A 7.0MMX19MMX90CM EXPRESS SD STENT WAS EXPANDED, HOWEVER; DOG-BONE EFFECT WAS NOTED. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10479604 ↗
• MalfunctionNov 20, 2018Premature Activation; Premature Activation

  IT WAS REPORTED THAT PREMATURE DEPLOYMENT OF STENT OCCURRED. A 7.0MMX19MMX90CM EXPRESS SD RENAL/BILIARY STENT WAS SELECTED TO TREAT THE LESION. HOWEVER, THE DEVICE WOULD NOT GO THROUGH THE SHEATH DUE TO THE LEADING END OF THE STENT WAS PARTLY OPENED. THE DEVICE NEVER ENTERED THE PATIENT AND IT WAS REPLACED WITH ANOTHER OF THE SAME DEVICE WHICH DEPLOYED WITH NO ISSUE TO SUCCESSFULLY COMPLETE THE CASE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT DID VERY WELL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8092627 ↗
• MalfunctionSep 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. DURING PREPARATION OF A 7.0MMX19MMX90CM EXPRESS SD RENAL/BILIARY STENT, UPON INSERTION INTO THE SHEATH, THE STENT CAME OFF THE STENT DELIVERY BALLOON. THE DEVICE NEVER ENTERED THE PATIENT'S BODY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7897559 ↗