Express® SD Renal/Biliary H74937912719150Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729390510), received between Oct 15, 2018 and May 12, 2025 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2025Deflation Problem; Difficult to Remove; Material Rupture; Material Integrity Problem; Deflation Problem; Difficult to Remove; Material Rupture; Material Integrity Problem

  IT WAS REPORTED THAT THE BALLOON BURST, AND A BALLOON FRAGMENT BECAME STUCK IN THE PLACED STENT, REQUIRING INTERVENTION. VASCULAR ACCESS WAS OBTAINED VIA RIGHT COMMON FEMORAL ARTERY. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND TORTUOUS LEFT RENAL ARTERY. A 6F NON-BOSTON SCIENTIFIC (BSC) SHEATH, GUIDE CATHETER AND .018 WIRE WAS USED. HOWEVER, THE WIRE WAS NOT SUPPORTIVE ENOUGH TO PLACE THE SHEATH DUE TO TORTUOUS LESION, THEREFORE, A .014 THRUWAY GUIDEWIRE WAS USED AND CROSSED. AFTERWARDS, THIS 7.0MMX19MMX150CM EXPRESS SD RENAL/BILIARY STENT BALLOON EXPANDABLE WAS ADVANCED OVER THE WIRE IN THE EXISTING PLACED STENT WITH SEVERE STENOSIS. THIS STENT WAS PLACED AND EXPANDED BUT, UPON SECOND INFLATION, THE BALLOON RUPTURED. WHEN DEFLATING THE BALLOON, SLOW DEFLATION WAS OBSERVED. THE DEVICE WAS THEN PULLED BACK INTO THE SHEATH, BUT RESISTANCE OCCURRED. A BALLOON FRAGMENT APPEARED TO BE STUCK IN THE PLACED STENT. UNDER X-RAY, THE DISTAL AND PROXIMAL RO MARKERS WERE OBSERVED IN THE NON-BSC 6F SHEATH, AND THE PHYSICIAN DECIDED TO REMOVE THE SHEATH, BALLOON SHAFT AND WIRE ALL TOGETHER. ANOTHER ANGIOGRAPHY WAS PERFORMED AND FOUND THE RENAL ARTERY TO BE OCCLUDED DU

  Patient problems: Foreign Body In Patient; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 22004683 ↗
• MalfunctionMay 1, 2024Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT WAS SLIGHTLY LOOSE ON THE BALLOON. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 7.0MM X 19MM X 150CM EXPRESS SD RENAL/BILIARY STENT BALLOON EXPANDABLE WAS SELECTED FOR TREATMENT. UPON OPENING, THE STENT STRUTS APPEARED DAMAGED, AND THE STENT APPEARED SLIGHTLY LOOSE OR NOT ATTACHED TO THE BALLOON. THE PROCEDURE WAS COMPLETED WITH A NEW 7.0MM X 19MM EXPRESS SD. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19225907 ↗
• InjurySep 29, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT AND CATHETER ENTRAPMENT WHICH REQUIRES SURGERY WAS ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. A 7.0MMX19MMX150CM EXPRESS SD CATHETER WAS ADVANCED FOR TREATMENT AFTER THE RADIAL ARTERY PUNCTURE WHICH WAS PASSED BY 0.014 WIRE ON 7FR SHEATH. HOWEVER, WHILE PASSING THROUGH THE SHEATH AND RADIAL ARTERY, THE STENT GOT CAUGHT IN THE CALCIFIED LESION AND FELL OUT OF THE BALLOON. THE STENT REMAINING IN THE BLOOD VESSEL IS REMOVED DURING OP AFTER THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT WAS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17846874 ↗
• MalfunctionMar 27, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT BALLOON SLOW DEFLATION AND REMOVAL DIFFICULTIES WERE ENCOUNTERED. THE STENOSED TARGET LESION WAS LOCATED IN CELIAC ARTERY. A 7.0MMX19MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS DEPLOYED SUCCESSFULLY FOR TREATMENT. HOWEVER, THE STENT BALLOON WOULD NOT FULLY DEFLATE MAKING IT DIFFICULT TO WITHDRAW THE BALLOON. EVERY NORMAL TECHNIQUE WAS MADE INCLUDING PULLING NEGATIVE PRESSURE WITH A SYRINGE. THE .018 WIRE, SHEATH, AND THE PARTIALLY INFLATED BALLOON WERE REMOVED AS ONE. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS WHILE THE BALLOON REMAINED INFLATED WHEN REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618033 ↗
• MalfunctionAug 11, 2022Contamination; Tear, Rip or Hole in Device Packaging; Packaging Problem; Contamination; Tear, Rip or Hole in Device Packaging; Packaging Problem

  IT WAS REPORTED THAT CONTAMINATION OCCURRED. A 7.0MMX19MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS SELECTED FOR USE IN A RENAL ANGIOGRAM AND INTERVENTION. HOWEVER, DURING PREPARATION, THE INNER PACKAGING APPEARED TO BE TORN IN ONE CORNER AND THE STERILITY WAS POSSIBLY COMPROMISED. ADDITIONALLY, THE OUTER PACKAGING WAS DENTED. A NEW EXPRESS SD RENAL/BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15212063 ↗
• InjuryFeb 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DISLODGEMENT INSIDE THE PATIENT OCCURED. A 7.0MMX19MMX150CM EXPRESS SD CATHETER WAS SELECTED. HOWEVER, DURING REPOSITIONING INSIDE THE PATIENTS BODY, STENT GOT DISLODGED. THE DISLODGED STENT WAS SAFELY RETRIEVE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8316990 ↗
• InjuryOct 15, 2018Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE CALCIFIED SUPERIOR MESENTERIC ARTERY. A 7.0MMX19MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE DEVICE WAS UNABLE TO CROSS THE LESION. WHEN THE DEVICE WAS REMOVED, THE STENT GOT HUNG UP ON THE NON-BSC INTRODUCER SHEATH IN THE RIGHT LEG AND IT WAS NOTED THAT IT CAME OFF THE BALLOON INTO THE BODY. A SNARE WAS USED TO RETRIEVE THE STENT OUT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7965755 ↗