Express LD Iliac / BiliaryRecalls & reported problems across all models
Boston Scientific Corporation · 34 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 211
- Deaths reported
- 1
- Injuries reported
- 97
- Recalls
- 0
We found 34 models of Express LD Iliac / Biliary by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 211 adverse event reports in the FDA's MAUDE database, received between Dec 19, 2016 and Sep 29, 2026 — classified as 1 death, 97 injuries, 113 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (131 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
Reports received per month, all models
Most reported Express LD Iliac / Biliary problems
Device problems
- Device Dislodged or Dislocated131
- Failure to Advance22
- Material Deformation21
- Difficult to Advance18
- Difficult to Remove14
- Material Rupture12
- Adverse Event Without Identified Device or Use Problem8
- Activation Failure7
Patient problems
- No Clinical Signs, Symptoms or Conditions108
- No Consequences Or Impact To Patient61
- No Patient Involvement13
- Foreign Body In Patient9
- No Known Impact Or Consequence To Patient8
- No Code Available7
- Insufficient Information3
- Perforation of Vessels3
Express LD Iliac / Biliary models
34 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Express® LD Iliac / Biliary H74938046740750STENT, ILIAC17 reports
- Express® LD Iliac / Biliary H74938046830750STENT, ILIAC15 reports
- Express® LD Iliac / Biliary H74938047730130STENT, ILIAC15 reports
- Express® LD Iliac / Biliary H74938047830130STENT, ILIAC15 reports
- Express® LD Iliac / Biliary H74938046840750STENT, ILIAC12 reports
- Express® LD Iliac / Biliary H74938047840130STENT, ILIAC12 reports
- Express® LD Iliac / Biliary H74938046730750STENT, ILIAC12 reports
- Express® LD Iliac / Biliary H74938047760130STENT, ILIAC10 reports
- Express® LD Iliac / Biliary H74938046104070STENT, ILIAC7 reports
- Express® LD Iliac / Biliary H74938046640750STENT, ILIAC7 reports
- Express® LD Iliac / Biliary H74938046760750STENT, ILIAC7 reports
- Express® LD Iliac / Biliary H74938047140130STENT, ILIAC7 reports
- Express® LD Iliac / Biliary H74938047740130STENT, ILIAC6 reports
- Express® LD Iliac / Biliary H74938046102070STENT, ILIAC5 reports
- Express® LD Iliac / Biliary H74938046620750STENT, ILIAC5 reports
- Express® LD Iliac / Biliary H74938046860750STENT, ILIAC5 reports
- Express® LD Iliac / Biliary H74938046940750STENT, ILIAC5 reports
- Express® LD Iliac / Biliary H74938047720130STENT, ILIAC5 reports
- Express® LD Iliac / Biliary H74938047630130STENT, ILIAC5 reports
- Express® LD Iliac / Biliary H74938046920750STENT, ILIAC4 reports
- Express® LD Iliac / Biliary H74938047860130STENT, ILIAC4 reports
- Express® LD Iliac / Biliary H74938046630750STENT, ILIAC4 reports
- Express® LD Iliac / Biliary H74938046106070STENT, ILIAC3 reports
- Express® LD Iliac / Biliary H74938046720750STENT, ILIAC3 reports
- Express® LD Iliac / Biliary H74938047660130STENT, ILIAC3 reports
- Express® LD Iliac / Biliary H74938047820130STENT, ILIAC3 reports
- Express® LD Iliac / Biliary H74938047920130STENT, ILIAC3 reports
- Express® LD Iliac / Biliary H74938046820750STENT, ILIAC2 reports
- Express® LD Iliac / Biliary H74938046960750STENT, ILIAC2 reports
- Express® LD Iliac / Biliary H74938047120130STENT, ILIAC1 death2 reports
- Express® LD Iliac / Biliary H74938047940130STENT, ILIAC2 reports
- Express® LD Iliac / Biliary H74938047960130STENT, ILIAC2 reports
- Express® LD Iliac / Biliary H74938046660750STENT, ILIAC1 report
- Express® LD Iliac / Biliary H74938047620130STENT, ILIAC1 report
Recent Express LD Iliac / Biliary adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933982 ↗InjuryMar 25, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE 80% STENOSED LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PERIPHERAL ARTERY. AN 8.0 X 30 MM X 135 CM EXPRESS LD ILIAC / BILIARY STENT SYSTEM WAS ADVANCED; HOWEVER, DIFFICULTY WAS ENCOUNTERED WHILE ADVANCING THE DEVICE OVER THE AORTIC ARCH. UPON CROSSING THE CALCIFIED LESION, THE STENT DISLODGED FROM THE DELIVERY BALLOON. THE STENT MIGRATED FROM THE COMMON ILIAC ARTERY TO THE EXTERNAL ILIAC ARTERY. THE PHYSICIAN ELECTED TO KEEP THE DISLODGED STENT AND USED A BALLOON TO EXPAND IT AGAINST THE VESSEL WALL AT THE EXTERNAL ILIAC ARTERY WITHIN THE DISEASED SEGMENT. THE STENT WAS NOT REMOVED, AS THE PHYSICIAN DETERMINED IT WAS ACCEPTABLE TO DEPLOY IT AT THAT LOCATION. THE PROCEDURE WAS COMPLETED WITHOUT REPORTED PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24689104 ↗MalfunctionMar 5, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT DISLODGEMENT OCCURRED. A 9.0X40X75CM EXPRESS LD SENT BALLOON EXPANDABLE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS INSERTED AND IT WAS OBSERVED THAT THE STENT WAS NOT ATTACHED TO THE BALLOON CATHETER. THE DETACHED STENT WAS REPORTEDLY FOUND ON THE SCRUB TABLE WHILE THE TEAM WAS PREPARING. THE ISSUE WAS NOT PRESENT UPON OPENING THE PACKAGE. THE PROCEDURE WAS THEN COMPLETED USING 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 24519577 ↗MalfunctionFeb 19, 2026Device Dislodged or Dislocated; Material Deformation
IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 7.0 X 40 X 75 CM EXPRESS LD STENT BALLOON WAS SELECTED FOR USE. UPON PREPARATION, IT WAS OBSERVED THAT THE STENT WAS NOT MOUNTED ON THE BALLOON PRIOR TO USE, AND STENT DAMAGE WAS NOTED. THE AFFECTED DEVICE WAS NOT USED FOR TREATMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24388565 ↗MalfunctionJan 28, 2026Failure to Advance; Device Dislodged or Dislocated
IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MODERATELY CALCIFIED ILIAC ARTERY. THE LESION WAS PREDILATED. AN 8.0 X 40 X 75 CM EXPRESS LD ILIAC/BILIARY BALLOON-EXPANDABLE STENT WAS ADVANCED FOR TREATMENT. WHILE ATTEMPTING TO ADVANCE THE DEVICE THROUGH THE LESION, THE STENT CAME OFF FROM THE BALLOON. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS RESULTING FROM THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24200222 ↗MalfunctionJan 8, 2026Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT A SMALL HOLE IN THE PACKAGING OCCURRED. A 9.0X40X135 CM EXPRESS LD STENT BALLOON EXPANDABLE WAS SELECTED FOR USE. UPON OPENING THE DEVICE, A SMALL HOLE WAS NOTICED IN THE OUTER PACKAGING, WHICH COMPROMISED THE STERILITY OF THE STENT. 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 24004887 ↗MalfunctionDec 21, 2025Difficult to Insert; Difficult to Insert
REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25NOV2025. IT WAS REPORTED THAT STENT WAS DIFFICULT TO INSERT. AN 8.0X60X75CM EXPRESS LD STENT WAS SELECTED FOR USE IN AN ILIAC STENTING PROCEDURE. DURING THE PROCEDURE, STENT WAS PREPARED ACCORDING TO STANDARD PROCEDURE BUT COULD NOT BE INTRODUCED INTO THE NON-BOSTON SCIENTIFIC SHEATH. THERE WAS NO VISIBLE DAMAGE TO THE DEVICE UPON OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATION AS THE RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE FIRST TWO ROWS OF THE PROXIMAL STENT STRUTS WERE FOUND TO BE LIFTED/DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23861096 ↗MalfunctionDec 4, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 7.0X20X135 CM EXPRESS LD ILIAC / BILIARY BALLOON EXPANDING WAS SELECTED FOR USE IN A LEG ANGIOGRAM. DURING INSERTION, IT WAS NOTED THAT THE STENT CAME OFF BALLOON. ANOTHER 7.0X20X135 CM EXPRESS LD ILIAC / BILIARY BALLOON EXPANDING WAS USED, HOWEVER SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23720233 ↗MalfunctionDec 4, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. A 7.0X20X135 CM EXPRESS LD ILIAC / BILIARY BALLOON EXPANDING WAS SELECTED FOR USE IN A LEG ANGIOGRAM. DURING INSERTION, IT WAS NOTED THAT THE STENT CAME OFF BALLOON. ANOTHER 7.0X20X135 CM EXPRESS LD ILIAC / BILIARY BALLOON EXPANDING WAS USED, HOWEVER SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23720231 ↗MalfunctionNov 5, 2025Difficult to Remove; Material Integrity Problem; Difficult to Remove; Material Integrity Problem
IT WAS REPORTED THAT STENT REMOVAL DIFFICULTY OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUBCLAVIAN ARTERY. A 10.0X40X75CM EXPRESS LD STENT BALLOON EXPANDING WAS SELECTED FOR USE. POST IMPLANTATION, IT WAS NOTED THAT THERE WAS RESISTANCE ENCOUNTERED AND THE BALLOON SEGMENT OF THE CATHETER BECAME DISCONNECTED. THE DISCONNECTED PORTION HAD REMAINED PARTIALLY WITHIN THE SHEATH; THEREFORE, THE SHEATH AND THE BROKEN CATHETER SEGMENT WERE ABLE TO BE REMOVED. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23478445 ↗MalfunctionOct 29, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT STENT MOVED ON THE BALLOON. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL MESENTERIC ARTERY. A 6.0X40X75CM EXPRESS LD WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS PLACED OVER A GUIDEWIRE, BUT THE PHYSICIAN OBSERVED THAT THE STENT WAS TOO LONG FOR THE LESION. WHILE REMOVING THE STENT SYSTEM, UNDER FLUOROSCOPY, IT WAS OBSERVED THAT THE STENT WAS COMING OFF THE BALLOON. THE PHYSICIAN IMMEDIATELY STOPPED, THEN ADVANCED THE SYSTEM FORWARD TO RETRIEVE THE STENT AND THE PROCEDURE WAS COMPLETED USING ALTERNATE DEVICE. THE STENT DID NOT COMPLETELY DISLODGE FROM THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23414458 ↗MalfunctionOct 21, 2025Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT STENT MOVED ON BALLOON OCCURRED. THE 60% STENOSED TARGET LESION WAS LOCATED IN THE MILD TORTUOUS AND MODERATELY CALCIFIED ILIAC ARTERY. A 7.0X40X135 CM EXPRESS LD WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT WAS INSERTED THROUGH A BSC 11CM 6F SHEATH. IT WAS NOTED THAT THE STENT COULD NOT CROSS THE TIGHT LESION. THE STENT WAS REMOVED. THE ARTERY WAS PRE-DILATED WITH A BSC .035 BALLOON 5X40 SUCCESSFULLY. THE LD STENT WAS REINSERTED THROUGH THE SHEATH AND CROSSED LESION. HOWEVER, ONCE THE STENT WAS POSITION ACROSS THE LESION, IT WAS NOTED THAT THE STENT WAS HALFWAY SLIDE BACK ON THE ITS BALLOON. THE SHEATH WAS REMOVED AND THE LD STENT CATHETER WAS REMOVED FROM THE BODY FULLY INTACT WITH BALLOON AND STENT 100% 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 23347886 ↗InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED COMPLICATIONS POST STENT IMPLANTATION. ON THE (B)(6) 2023, A 6.0X30X75CM EXPRESS LD STENT WAS IMPLANTED IN THE RENAL ARTERY AND A CLOSURE DEVICE WAS USED ON THEIR ILIAC DURING AN ANEURYSM REPAIR COMPLICATION. SINCE THEN, THE PATIENT NEVER HAD A FOLLOW UP VISIT (SUCH AS MAGNETIC RESONANCE ANGIOGRAPH (MRA) OR COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA)). FOR OVER A YEAR, THE PATIENT HAD A BURNING SENSATION IN THEIR COCCYX AREA, FECAL INCONTINENCE, URINE INCONTINENCE, NUMBNESS IN THEIR RIGHT LEG AFTER WALKING A RELATIVELY SHORT DISTANCE THAT WOULD GET BETTER WITH REST, DIFFICULTY STANDING UP AFTER SITTING FOR A WHILE, THIRST, AND THE KIDNEYS INFARCTED TO THE POINT OF FALLING TO CHRONIC KIDNEY DISEASE (CKD) STAGE 3, A GLOMERULAR FILTRATION RATE (GFR) OF 50 THAT WAS THE LOWEST REGISTERED, AND HIGH BLOOD PRESSURE. THE PATIENT ALSO DEVELOPED POST-TRAUMATIC STRESS DISORDER (PTSD) BELIEVED TO BE BECAUSE THE PROCEDURE WAS PERFORMED WITHOUT ANESTHESIA. THE ONLY FOLLOW-UP THE PATIENT RECEIVED WAS A NON-CONTRAST COMPUTED TOMOGRAPHY (CT) SCAN THAT SHOWED THE STENT STILL IMPLANTED, AND A DOPPLER TEST TO CHECK ON THE FEMORAL AND EXTERNAL ILIAC ARTERY. IT WAS FURT
Patient problems: Burning Sensation; Fecal Incontinence; High Blood Pressure/ Hypertension; Numbness; Renal Impairment; Urinary Incontinence
MAUDE report 23328328 ↗MalfunctionAug 14, 2025Material Deformation; Material Deformation
IT WAS REPORTED THAT THE STENT CAME LOOSE FROM THE BALLOON. A 7.0X40X135 CM EXPRESS LD BALLOON STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS FOUND THAT STENT CAME LOOSE FROM THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22804982 ↗InjuryAug 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 9.0X60X135 CM EXPRESS LD STENT BALLOON WAS SELECTED FOR PROCEDURE. DURING THE PROCEDURE, THE STENT UNINTENTIONALLY DISLODGED BEFORE REACHING THE LESION. THE PHYSICIAN THEN RELEASED THE STENT AT ITS CURRENT LOCATION. 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 22727595 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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