Express® SD Renal/Biliary H74937912618150Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 08714729484844), received between Oct 8, 2018 and Sep 9, 2026 — classified as 8 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 25 most recent of 27 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMay 10, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT STENT DIFFICULTY TO POSITION OCCURRED. THE PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND STENTING PROCEDURE. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED RENAL ARTERY. A 6.0MMX18MMX150CM EXPRESS SD RENAL/BILIARY STENT BALLOON EXPANDABLE WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE WHEN DEPLOYING THE STENT, THE DEVICE MOVED A LITTLE BIT FROM THE TARGET. THE PROCEDURE WAS COMPLETED USING THIS DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT STATUS WAS GOOD. THE DEVICE REMAINS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19286923 ↗
• MalfunctionFeb 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS RENAL ARTERY. A 6.0MMX18MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE STENT GOT DETACHED AND SLID ON THE DELIVERY SYSTEM. THE STENT WAS PULLED OUT FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18662719 ↗
• MalfunctionDec 1, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE PATIENT WAS BEING TREATED FOR RENAL ARTERY STENOSIS. A 6.0MMX18MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, UPON INSERTING THE DEVICE INTO A 6FR GUIDE CATHETER, THE STENT STRUTS AND THE DELIVERY SHAFT WERE KINKED. THE DEVICE WAS REMOVED INTACT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18245864 ↗
• MalfunctionSep 29, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 6.0MM X 18MM X 150CM EXPRESS SD RENAL/BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTICED THAT THE DISTAL SEGMENT OF THE STENT WAS OPENED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843195 ↗
• MalfunctionSep 27, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OUTSIDE THE PATIENT OCCURRED. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT RENAL ARTERY. A 6.0MMX18MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS SELECTED FOR USE. THE STENT WAS LOOSE ON THE BALLOON WHEN THE PHYSICIAN REMOVED THE STENT CATHETER FROM THE CIRCULAR HOUSING. DURING PREPARATION OUTSIDE THE PATIENT, THE CATHETER WAS FLUSHED, AND IT WAS NOTICED THAT THE STENT ITSELF WAS LOOSE AND NOT ADHERED PROPERLY TO THE BALLOON, WHICH LED TO THE STENT FALLING OFF FROM THE BALLOON IT WAS ATTACHED TO. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17824202 ↗
• InjuryJul 8, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENCOUNTERED AND THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED CELIAC ARTERY. A 6.0MMX18MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, THE STENT FAILED TO CROSS THE LESION AND IT BECAME STUCK. THE DEVICE WAS DIFFICULT TO REMOVE AND SNARING WAS PERFORMED. THE PROCEDURE WAS ABANDONED AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14958459 ↗
• MalfunctionMar 9, 2022Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 6.0MMX18MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE SHAFT OF THE STENT GOT BUCKLED AND SNAPPED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13702723 ↗
• MalfunctionDec 16, 2020Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT REMOVAL DIFFICULTY OCCURRED. A 6.0MMX18MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THE STENT DELIVERY SYSTEM WOULD NOT COME BACK THROUGH THE 5F SHEATH. THE BALLOON WAS COMPLETELY DEFLATED, SO THE WIRE, BALLOON AND THE GUIDE HAD TO BE REMOVED. THE PROCEDURE WAS COMPLETED WITH IMAGING, FROM A PIG TAIL CATHETER. THE PHYSICIAN WAS NOT ABLE TO REWIRE AND ENGAGE THE STENT FOR POST IMAGES. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11019519 ↗
• MalfunctionAug 4, 2020Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT REMOVAL DIFFICULTIES WERE ENOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 5F NON-BSC SHEATH WAS INSERTED AND THE LESION WAS ENGAGED WITH A 6F NON-BSC GUIDE CATHETER. A 6.0MMX18MMX150CM EXPRESS SD STENT WAS ADVANCED BUT HAD DIFFICULTY ADVANCING THROUGH THE GUIDE CATHETER. AFTER THE STENT WAS SUCCESSFULLY DEPLOYED INTO THE RENAL ARTERY, THE BALLOON THAT THE STENT WAS MOUNTED ON WAS DIFFICULT TO REMOVE FROM A NON-BSC GUIDE CATHETER; HOWEVER, IT WAS SUCCESSFULLY REMOVED AFTER MUCH FORCE WAS APPLIED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10362484 ↗
• MalfunctionMar 24, 2020Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 6.0MMX18MMX150CM EXPRESS SD STENT BALLOON EXPANDABLE WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE STENT DELIVERY SYSTEM WAS UNABLE TO CROSS THE LESION AND THE RAILING BROKE WHILE TRYING TO CROSS WITH THE STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9872579 ↗
• MalfunctionDec 12, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 6.0MMX18MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS SELECTED FOR USE. HOWEVER, BEFORE INSERTING THE DEVICE INTO THE PATIENT'S BODY, IT WAS NOTICED THAT SOME STENT STRUTS APPEARED TO BE FLARED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 9462259 ↗
• InjuryOct 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED ILIAC VESSEL. A 6.0MM X 18MM X 150CM EXPRESS SD RENAL/BILIARY STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, UPON INSERTING THE DEVICE, THE STENT CAME OFF THE BALLOON AND BECAME STUCK IN THE PATIENT'S FEMORAL ARTERY. THE PHYSICIAN ATTEMPTED TO PULL THE STENT OUT WITH A DIFFERENT BALLOON BUT WAS UNSUCCESSFUL. THE OR TEAM WAS THEN CALLED TO PERFORM A CUTDOWN TO REMOVE THE STENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198747 ↗
• MalfunctionJul 26, 2019Contamination; Contamination

  IT WAS REPORTED THAT THE PRODUCT WAS CONTAMINATED. DURING PREPARATION OF A 6.0MM X 18MM X 150CM EXPRESS SD STENT, IT WAS NOTICED THAT THE PRODUCT TOUCHED AN UNSTERILE FIELD. THE DEVICE WAS NOT USED INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Patient Involvement

  MAUDE report 8831506 ↗
• MalfunctionJul 19, 2019Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02JUL2019. IT WAS REPORTED THAT SHAFT KINK OCCURRED. A 6.0MMX18MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS SELECTED FOR USE. HOWEVER, IT WAS NOTED THAT THE DEVICE WAS KINKED. NO KNOWN PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED STENT DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8807927 ↗
• MalfunctionJun 11, 2019Break; Break

  IT WAS REPORTED THAT SHAFT BREAK OCCURRED. DURING PREPARATION OF A 6.0 MM X 18 MM X 150 CM EXPRESS SD RENAL/BILIARY, IT WAS NOTED THAT THE MID PORTION OF THE SHAFT WAS FRACTURED. THE DEVICE WAS NOT ENTERED INTO THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT' STATUS WAS FINE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8688484 ↗
• InjuryMay 23, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SUPERIOR MESENTERIC ARTERY. A 6.0MMX18MMX150CM EXPRESS SD STENT WAS ADVANCED FOR TREATMENT, HOWEVER, THE DEVICE FAILED TO CROSS THE LESION SEVERAL TIMES AND THE STENT CAME OFF THE BALLOON. THE PHYSICIAN TRIED TO SNARE IT BUT WAS UNSUCCESSFUL AND IT WENT INTO THE AORTA. THE DISLODGED STENT LANDED IN THE RIGHT INTERNAL ILIAC ARTERY WHERE THE PHYSICIAN LEFT IT. THE PROCEDURE WAS COMPLETED WITH A NON-BSC STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8636935 ↗
• MalfunctionMay 22, 2019Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT SHAFT BREAK OCCURED. THE TARGET LESION WAS LOCATED IN THE LEFT RENAL ARTERY. A 6.0MMX18MMX150CM EXPRESS SD RENAL/BILIARY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, DURING PROCEDURE, IT WAS NOTED THAT THEY TRIED TO ADVANCED THE STENT BUT IT WOULD NOT DEPLOY. THE DEVICE BROKE INSIDE THE PATIENT'S BODY BUT THEY SUCCESSFULLY REMOVED IT. THE PROCEDURE WS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS NOR INJURIES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8632978 ↗
• MalfunctionApr 24, 2019Contamination; Contamination

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. A 6.0MMX18MMX150CM EXPRESS SD RENAL/BILIARY DRUG ELUTING WAS SELECTED FOR USE. HOWEVER, BEFORE IT WENT TO THE BODY, THE DEVICE GOT CONTAMINATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8546895 ↗
• InjuryJan 8, 2019Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A DISSECTION OCCURRED. A 7FR 100CM GUIDE CATHETER AND 200CM V18 GUIDEWIRE WERE USED TO ACCESS THE LESION IN THE STENOSED LEFT RENAL ARTERY. PRE-DILATION WAS PERFORMED. A 5.0MMX15MMX150CM EXPRESS SD RENAL/BILIARY AND 6.0MMX18MMX150CM EXPRESS SD RENAL/BILIARY WERE SELECTED FOR USE BUT FAILED TO CROSS THE STENOSIS AFTER MULTIPLE ATTEMPTS TO BE PLACED AT THE TARGET SITE DUE TO THE ANGLED RENAL ARTERY. A DISSECTION OCCURRED AT THE ENTRY OF THE LEFT RENAL ARTERY. ANGIOPLASTY WAS PERFORMED TO ASSURE NORMAL BLOOD FLOW. THE PATIENT WAS PLACED UNDER OBSERVATION AND RESCHEDULED FOR ANOTHER RENAL ARTERY STENTING PROCEDURE. THE PATIENT WAS STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 8228461 ↗
• InjuryDec 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE STENT DISLODGED. AN EXPRESS SD RENAL/BILIARY STENT WAS SELECTED FOR USE FOR AN ANGIOPLASTY AND STENT PROCEDURE IN THE LEFT RENAL ARTERY. DURING THE PROCEDURE, THE STENT BECAME DISLODGED OFF OF THE BALLOON AT THE LOCATION OF THE LEFT RENAL ARTERY. THE STENT EXPANDED WITH NO ADDITIONAL PROBLEMS AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8161980 ↗
• MalfunctionNov 20, 2018Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE HEAVILY CALCIFIED LEFT RENAL ARTERY. A 6.0MMX18MMX150CM EXPRESS SD RENAL/BILIARY STENT WAS ADVANCED TO TREAT THE LESION; HOWEVER, DIFFICULTY ADVANCING WAS ENCOUNTERED. THE PHYSICIAN EXERTED MUCH PRESSURE CAUSING THE DELIVERY SYSTEM SHAFT TO BEND AT THE LEVEL OF THE STENT. THE STENT ADVANCED PARTIALLY ACROSS THE OSTIUM OF THE RENAL ARTERY. UPON REMOVAL OF THE UN-DEPLOYED STENT DELIVERY SYSTEM (SDS), IT WAS NOTED THAT THE STENT SEPARATED FROM THE BALLOON SHAFT BUT REMAINED ON THE WIRE. THE SDS WAS ADVANCED UP TO LEVEL OF STENT AND PARTIAL RECAPTURE ACCOMPLISHED. THE STENT WAS PULLED BACK INTO THE SHEATH AND THE ENTIRE SDS, SHEATH, AND THE STENT WERE REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS ENDED AND THE PATIENT WILL RETURN FOR THE SAME PROCEDURE, BUT USING A DIFFERENT APPROACH. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8092419 ↗