Express SD Renal/BiliaryRecalls & reported problems across all models

We found 15 models of Express SD Renal/Biliary by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 81 adverse event reports in the FDA's MAUDE database, received between Sep 21, 2018 and Sep 9, 2026 — classified as 31 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (28 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Express SD Renal/Biliary problems

Express SD Renal/Biliary models

15 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Express® SD Renal/Biliary H74937912618150

  STENT, RENAL
  27 reports
• Express® SD Renal/Biliary H74937912618900

  STENT, RENAL
  8 reports
• Express® SD Renal/Biliary H74937912719150

  STENT, RENAL
  7 reports
• Express® SD Renal/Biliary H74937911515150

  STENT, RENAL
  6 reports
• Express® SD Renal/Biliary H74937911715150

  STENT, RENAL
  6 reports
• Express® SD Renal/Biliary H74937912719900

  STENT, RENAL
  6 reports
• Express® SD Renal/Biliary H74937911614150

  STENT, RENAL
  4 reports
• Express® SD Renal/Biliary H74937911614900

  STENT, RENAL
  4 reports
• Express® SD Renal/Biliary H74937911715900

  STENT, RENAL
  3 reports
• Express® SD Renal/Biliary H74937912519150

  STENT, RENAL
  3 reports
• Express® SD Renal/Biliary H74937912519900

  STENT, RENAL
  3 reports
• Express® SD Renal/Biliary H74937911415150

  STENT, RENAL
  1 report
• Express® SD Renal/Biliary H74937911515900

  STENT, RENAL
  1 report
• Express® SD Renal/Biliary H74937912419150

  STENT, RENAL
  1 report
• Express® SD Renal/Biliary H74937912419900

  STENT, RENAL
  1 report

Recent Express SD Renal/Biliary adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 9, 2026Device Dislodged or Dislocated

  It was reported that the stent moved on balloon.The target lesion was located in the super mesenteric artery. A 6.0mmX18mmX150cm Express SD stent balloon expandable was selected for use in a mesenteric angiogram. During the procedure, an attempt was made to deploy the stent. However, the stent came off of the balloon. The device was removed, and the procedure was completed with another of the same device. There were no patient complications as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50692010 ↗
• InjuryJun 26, 2026Difficult to Remove

  IT WAS REPORTED THAT THE STENT BALLOON WAS DIFFICULT TO WITHDRAW FROM THE STENT REQUIRING ADDITIONAL INTERVENTION. A 7.0MMX15MMX150CM EXPRESS SD RENAL/BILIARY BALLOON EXPANDABLE STENT WAS USED DURING A RENAL STENTING PROCEDURE. THE 85% STENOSED TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED VESSEL WHICH WAS PRE-DILATED USING A 4X15 BALLOON. THEN THE EXPRESS SD STENT WAS PLACED WITHOUT ANY ISSUES; HOWEVER, THE BALLOON COULD NOT BE RETRACTED THROUGH THE 7FR GUIDE CATHETER AND BECAME STUCK FOR 22 MINUTES. THE PHYSICIAN ACCESSED THE OPPOSITE SIDE, ENGAGED THE DEPLOYED EXPRESS SD STENT AND USED A 2X12 BALLOON TO DETACH THE BALLOON FROM THE STENT STRUTS. THE BALLOON WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND WAS FULLY INTACT WITH NO PART OF THE BALLOON REMAINING IN THE PATIENTS BODY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25638477 ↗
• MalfunctionJun 25, 2026Activation Failure

  IT WAS REPORTED THAT STENT FAILURE TO EXPAND OCCURRED. THE TARGET LESION WAS LOCATED IN THE VERY TORTUOUS AND TIGHT SUPERIOR MESENTERIC ARTERY. A 6.0MMX14MMX150CM EXPRESS SD RENAL/BILIARY WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS NOT FULLY EXPANDED IN THE LESION. 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 25627571 ↗
• MalfunctionMay 13, 2026Entrapment of Device; Difficult to Insert; Physical Resistance/Sticking

  IT WAS REPORTED THAT DEVICE ENTRAPMENT OCCURRED. THE 76% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED RENAL ARTERY. A 6.0MM X 18MM X 150CM EXPRESS SD RENAL/BILIARY STENT BALLOON EXPANDABLE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE EXPRESS SD RENAL/BILIARY DEVICE WAS DIFFICULT TO LOAD ONTO THE 0.014" NON-BOSTON SCIENTIFIC GUIDEWIRE AND COULD NOT BE FULLY ADVANCED THROUGH THE MACH 1 GUIDE CATHETER. THE EXPRESS SD RENAL/BILIARY BECAME STUCK ON THE GUIDEWIRE, REQUIRING BOTH DEVICES TO BE REMOVED SIMULTANEOUSLY. THE RENAL ARTERY WAS THEN RE-WIRED, AND THE PHYSICIAN ELECTED TO BALLOON THE LESION WITH A STERLING BALLOON TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25166443 ↗
• MalfunctionMar 17, 2026Difficult to Open or Remove Packaging Material; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 6.0MM X 18MM X 90CM EXPRESS SD RENAL/BILIARY WAS SELECTED FOR USE. UPON OPENING THE PACKAGE, IT WAS NOTED THAT THE STENT WAS BROKEN INSIDE THE PACKAGING. ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24620084 ↗
• MalfunctionDec 22, 2025Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 4.0MMX15MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS SELECTED FOR USE DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. THE STENOSED TARGET LESION WAS LOCATED IN THE RENAL VESSEL. DURING THE PROCEDURE, DAMAGE WAS NOTED TO THE STENT STRUT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23864796 ↗
• MalfunctionDec 12, 2025Break; Fracture; Adverse Event Without Identified Device or Use Problem; Break; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FRACTURE OCCURRED. A 6.0MMX18MMX150CM EXPRESS SD STENT BALLOON EXPANDABLE WAS SELECTED FOR USE IN AN ENDOVASCULAR ANEURYSM REPAIR (EVAR). DURING THE PROCEDURE, THE BALLOON AND STENT SHAFT WERE SEPARATED FROM THE CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS THE RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23790551 ↗
• 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 ↗
• MalfunctionSep 3, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SHAFT BREAK OCCURRED. THE 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND NON-CALCIFIED PULMONARY VESSEL. A 5.0MMX19MMX150CM EXPRESS SD STENT BALLOON EXPANDABLE WAS SELECTED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. DURING THE PROCEDURE, THE SHAFT OF THE STENT WAS SNAPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955330 ↗
• 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 ↗
• InjuryJan 27, 2025Entrapment of Device; Fracture; Entrapment of Device; Fracture

  IT WAS REPORTED THAT THE WIRE BECAME WRAPPED WITH THE STENT AND BROKE OFF, REQUIRING SNARE FOR REMOVAL. A 5.0MMX19MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS SELECTED FOR MESENTERIC STENTING. HOWEVER, DURING DEPLOYMENT, IT WAS NOTED THAT THE STENT AND WIRE BECAME WRAPPED AND BROKE OFF. THE BROKEN PIECES OF THE STENT AND WIRE WERE SNARED OUT AND THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21246306 ↗
• MalfunctionJan 22, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 5.0MMX19MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS USED IN THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT STRUT WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21207957 ↗
• InjuryNov 19, 2024Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT FRACTURED, REQUIRING SURGERY FOR REMOVAL. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED MESENTERIC ARTERY. A 6.0MMX18MMX90CM EXPRESS SD RENAL/BILIARY STENT BALLOON EXPANDABLE WAS ADVANCED FOR BALLOON ANGIOPLASTY AND STENT PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN USED AN 6F X 45CM ANGLED NON-BOSTON SCIENTIFIC (BSC) INTRODUCER SHEATH AS A PROTECTION IN THE RIGHT COMMON FEMORAL ARTERY TO EXPOSE THE STENT. UPON DOING SO, THE STENT BALLOON PULLED BACK. WHEN ADVANCING FORWARD, THE STENT ABRUPTLY RELEASED FROM THE BALLOON SHAFT. THE STENT REMAINED UNDEPLOYED OVER THE NON-BSC WIRE DISTALLY. THE PHYSICIAN DEPLOYED A SINGLE LOOP SNARE TO REMOVE THE DISTAL END OF THE WIRE AND STENT. THEN, ATTEMPTED TO REMOVE THE STENT THROUGH THE 6F NON-BSC SHEATH BUT WITHOUT SUCCESS. THE PHYSICIAN THEN INSERTED AN 8F X 45CM NON-BSC SHEATH IN THE LEFT COMMON FEMORAL ARTERY TO APPROACH FROM THE OTHER SIDE AND REMOVE IT THROUGH A LARGER SHEATH. A THREE-LOOP SNARE FROM THE LEFT COMMON FEMORAL ARTERY WAS INSERTED AND THEN SNARED THE STENT, BUT THEN AGAIN IT WAS UNSUCCESSFUL. THE PHYSICIAN DECIDED TO USE AN 8X39CM NON-BSC STENT TO COVER THE E

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20729709 ↗
• MalfunctionSep 23, 2024Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem

  IT WAS REPORTED THAT DIFFICULTY REMOVING THE STENT OCCURRED. AN EXISTING STENT WAS IN PLACE WITH HIGH GRADE STENOSIS. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY AND WAS PRE-DILATED WITH A 6X20 .018 NON-BSC BALLOON FOR 1 MINUTE. FOLLOWING EXCHANGE OF V-18 GUIDEWIRE FOR AN AMPLATZ, A SHEATH WAS ADVANCED THROUGH THE EXISTING STENT. A 7.0MMX15MMX150CM EXPRESS SD STENT BALLOON WAS SENT THROUGH THE SHEATH AND THE BALLOON INFLATED TO 14 ATMOSPHERES FOR 1 MINUTE. HOWEVER, AFTER DEFLATION, THE BALLOON WOULD NOT WITHDRAW. THERE WAS NO KINK OR TWIST IN THE SHEATH, AND THE WIRE HAD TO BE PULLED TO WITHDRAW THE BALLOON. UPON VISUAL INSPECTION, IT APPEARED THAT THE BALLOON DID NOT REWRAP. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20280731 ↗
• InjuryMay 17, 2024Material Rupture; Activation Failure; Material Rupture; Activation Failure

  IT WAS REPORTED THAT BALLOON RUPTURE AND STENT APPOSITION FAILURE OCCURRED. THE SEVERELY STENOSED TARGET LESION WAS LOCATED IN THE SUBCLAVIAN ARTERY. A 6.0MMX18MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE BALLOON FAILED TO EXPAND DUE TO SEVERE STENOSIS RESULTING IN THE FAILURE OF THE STENT TO APPOSE THE VESSEL WALL. IT WAS NOTED THAT THE BALLOON RUPTURED AND WAS REMOVED. THE STENT WAS SURGICALLY REMOVED, AND SURGICAL FIX OF THE VESSEL/GRAFT WAS PERFORMED. THE PROCEDURE WAS COMPLETED. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19343303 ↗

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