WallFlex BiliaryRecalls & reported problems across all models

We found 23 models of WallFlex Biliary by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 524 adverse event reports in the FDA's MAUDE database, received between Nov 17, 2016 and Sep 30, 2026 — classified as 6 deaths, 271 injuries, 247 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (125 reports).

1 FDA recall record name at least one of these models by its device identifier.

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

WallFlex Biliary recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Aug 7, 2020Terminated

   Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device

   Z-2958-2020 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported WallFlex Biliary problems

WallFlex Biliary models

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

• WallFlex Biliary M00570370

  Biliary stent system for benign strictures
  1 recall3 deaths166 reports
• WallFlex™ Biliary M00570530

  CATHETER, BILIARY, DIAGNOSTIC
  1 death52 reports
• WallFlex Biliary M00570360

  Biliary stent system for benign strictures
  44 reports
• WallFlex™ Biliary M00570640

  CATHETER, BILIARY, DIAGNOSTIC
  1 death42 reports
• WallFlex Biliary M00570380

  Biliary stent system for benign strictures
  36 reports
• WallFlex™ Biliary M00570650

  CATHETER, BILIARY, DIAGNOSTIC
  33 reports
• WallFlex™ Biliary M00570540

  CATHETER, BILIARY, DIAGNOSTIC
  32 reports
• WallFlex™ Biliary M00570730

  CATHETER, BILIARY, DIAGNOSTIC
  1 death30 reports
• WallFlex™ Biliary M00570660

  CATHETER, BILIARY, DIAGNOSTIC
  15 reports
• WallFlex™ Biliary M00570740

  CATHETER, BILIARY, DIAGNOSTIC
  15 reports
• WallFlex™ Biliary M00570520

  CATHETER, BILIARY, DIAGNOSTIC
  15 reports
• WallFlex™ Biliary M00570890

  CATHETER, BILIARY, DIAGNOSTIC
  12 reports
• WallFlex™ Biliary M00570620

  CATHETER, BILIARY, DIAGNOSTIC
  5 reports
• WallFlex™ Biliary M00570630

  CATHETER, BILIARY, DIAGNOSTIC
  5 reports
• WallFlex™ Biliary M00570720

  CATHETER, BILIARY, DIAGNOSTIC
  5 reports
• WallFlex™ Biliary M00570500

  CATHETER, BILIARY, DIAGNOSTIC
  3 reports
• WallFlex Biliary M00570340

  Biliary stent system for benign strictures
  3 reports
• WallFlex Biliary M00570350

  Biliary stent system for benign strictures
  3 reports
• WallFlex™ Biliary M00570600

  CATHETER, BILIARY, DIAGNOSTIC
  2 reports
• WallFlex™ Biliary M00570610

  CATHETER, BILIARY, DIAGNOSTIC
  2 reports
• WallFlex™ Biliary M00570700

  CATHETER, BILIARY, DIAGNOSTIC
  2 reports
• WallFlex™ Biliary M00570710

  CATHETER, BILIARY, DIAGNOSTIC
  1 report
• WallFlex™ Biliary M00570510

  CATHETER, BILIARY, DIAGNOSTIC
  1 report

Recent WallFlex Biliary adverse event reports

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

• MalfunctionSep 30, 2026Premature Activation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949566 ↗
• MalfunctionSep 21, 2026Premature Activation

  It was reported to Boston Scientific Corporation that a WallFlex Biliary Stent was attempted to be implanted during an ERCP (Endoscopic Retrograde Cholangiopancreatography) procedure for biliary obstruction performed on (b)(6) 2026.During the procedure, at the end of the case, the physician requested a 10 x 60 mm fully covered WallFlex stent. The device packaging was undamaged; however, upon opening the package, the stent was found to be already deployed within the sealed package. A new stent was opened and successfully deployed. The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838813 ↗
• MalfunctionSep 11, 2026Activation, Positioning or Separation Problem; Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50741072 ↗
• MalfunctionSep 4, 2026Material Deformation; Packaging Problem

  It was reported to Boston Scientific Corporation that a Wallflex Biliary RX Uncovered Stent was intended to be used on an unspecified date.A break/fracture was reported during transit or upon receipt at the hospital. It was reported that the stents were found damaged during shipping. There was no patient involvement.***Additional Information Received in August 05, 2026 and September 08, 2026***It was reported that the damage was observed on the package itself. The observed damage as to the packaging of the box and onto the packaging of the device. There was a distinct smell noted.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50600643 ↗
• InjuryJul 27, 2026Positioning Problem

  It was reported to Boston Scientific Corporation that a Wallflex Biliary RX Covered Stent was implanted in the biliary tract to treat a biliary stenosis during a stent placement procedure performed on (b)(6) 2026. Post procedure, it was noted that the stent was dislodged. The device was removed, and a different device was used to complete the procedure. There were no patient complications as a result of this event and the patient condition following the procedure was reported to be stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50047758 ↗
• InjuryJul 20, 2026Activation Failure

  It was reported to Boston Scientific Corporation that a WallFlex Biliary Stent was to be implanted to treat a common bile duct (CBD) stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ERCP) with metal stenting procedure performed on (b)(6) 2026. During stent deployment, the physician and nursing staff observed that the stent failed to fully expand despite waiting approximately three minutes. Consequently, the physician elected to remove the stent using forceps. Another WallFlex Biliary Stent was used to complete the procedure. There were no patient complications as a result of this event and the patient condition following the procedure was stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25883946 ↗
• InjuryJun 25, 2026Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX RX FULLY COVERED BILIARY STENT WAS IMPLANTED TO TREAT A PANCREATIC HEAD MASS WITH STRICTURE IN THE DISTAL COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE WALLFLEX STENT WAS SUCCESSFULLY PLACED WITH NO COMPLICATIONS. HOWEVER, A FEW DAYS POST-STENT PLACEMENT, DURING AN EMERGENT FOLLOW-UP, IT WAS NOTED THAT THE PATIENT'S LIVER FUNCTION TEST RESULTS HAD SUDDENLY INCREASED, AND THE PATIENT COMPLAINED OF PAIN. IMAGING WAS PERFORMED, AND NO METAL STENT WAS LOCATED. IN THE PHYSICIAN'S ASSESSMENT, THE STENT HAD MIGRATED DISTALLY. THE PATIENT THEN UNDERWENT A REPEAT ERCP, AND A NEW BILIARY METAL STENT WAS PLACED.

  Patient problems: Foreign Body In Patient; Liver Damage/Dysfunction; Obstruction/Occlusion; Pain; Restenosis

  MAUDE report 25627515 ↗
• InjuryMay 27, 2026Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS ATTEMPTED TO BE IMPLANTED TO THE COMMON BILE DUCT TO TREAT A BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. DURING PROCEDURE, IN THE ATTEMPT TO DEPLOY THE STENT, THE STENT WAS KINKED AND MALFUNCTIONED. THE PROCEDURE WAS COMPLETED USING A NON-BOSTON SCIENTIFIC DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25303099 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  BOSTON SCIENTIFIC (BSC) ON (B)(6) 2026, IN CONNECTION WITH LEGAL PROCEEDINGS, BECAME AWARE OF AN ALLEGED EVENT THAT OCCURRED OVER 3 YEARS AGO. THE ALLEGATIONS DESCRIBED HEREIN HAVE NOT BEEN CONFIRMED INDEPENDENTLY BY BSC, AS BSC HAS NOT RECEIVED OTHER CORROBORATING DOCUMENTATION OR INFORMATION OUTSIDE OF THE LEGAL PROCEEDINGS RELATED TO THE ALLEGATIONS. THE GASTROENTEROLOGIST AND HIS ATTORNEY INVOLVED IN THE LEGAL PROCEEDINGS COMMUNICATED TO BSC THAT A WALLFLEX FULLY COVERED REMOVABLE (RMV) 10 MM BY 8 CM (WALLFLEX) STENT WAS DEPLOYED ON (B)(6) 2023 (DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP)) TO TREAT A STRICTURE FORMED BY MISPLACEMENT OF A SURGICAL CLIP USED TO TREAT BLEEDING OF THE CYSTIC ARTERY, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PERFORMED ON (B)(6) 2023. UPON FURTHER INVESTIGATION, BSC LOCATED THE FILED LEGAL COMPLAINT WITH THE DISTRICT COURT OF BOULDER, COLORADO AGAINST THE PATIENT'S HEALTHCARE PROVIDERS, INCLUDING THE GASTROENTEROLOGIST. IN THIS LEGAL COMPLAINT, IT WAS ALLEGED THAT THE GASTROENTEROLOGIST DEVIATED FROM THE STANDARD OF CARE IN THAT HE FAILED TO APPROPRIATELY PLACE THE BILIARY STENT AND FAILED TO USE THE APPROPRIATE TYPE AND SIZE OF STENT

  Patient problems: Abscess; Biliary Leak; Erosion; Hemorrhage/Blood Loss/Bleeding; Hyperbilirubinemia; Jaundice; Perforation; Unspecified Infection

  MAUDE report 25249803 ↗
• MalfunctionMay 7, 2026Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS ATTEMPTED TO BE IMPLANTED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2026, IT WAS REPORTED THAT DURING UNPACKING OUTSIDE THE PATIENT, THE TIP OF THE STENT WAS FOUND BENT. ANOTHER WALFLEX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25119167 ↗
• InjuryApr 27, 2026Use of Device Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY RX FULLY COVERED STENT RMV WAS TO BE IMPLANTED TO TREAT A BILE LEAK IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED; HOWEVER, IT WAS NOTED THAT THE PROXIMAL FLANGE OPENED OUTSIDE THE AMPULLA, WHILE THE DISTAL FLANGE DID NOT OPEN. THE PHYSICIAN ATTEMPTED TO RECAPTURE THE STENT TO FACILITATE PROPER DEPLOYMENT; HOWEVER, THE DISTAL FLANGE REMAINED UNOPENED. AN EXTRACTOR BALLOON WAS SUBSEQUENTLY USED IN AN ATTEMPT TO OPEN THE STENT, BUT THIS MANEUVER WAS UNSUCCESSFUL. THE STENT WAS THEN REMOVED USING FORCEPS, AND THE PROCEDURE WAS COMPLETED USING A PLASTIC STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. NOTE: ACCORDING TO THE COMPLAINANT, THE WALLFLEX BILIARY RX FULLY COVERED RMV STENT WAS PLACED TO TREAT A BILE LEAK. HOWEVER, PER THE WALLFLEX BILIARY RX FULLY COVERED STENT SYSTEM RMV DIRECTIONS FOR USE, THE STENT IS INDICATED FOR USE IN THE PALLIATIVE TREATMENT OF BILIARY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002447 ↗
• InjuryMar 30, 2026Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY FULLY COVERED STENT RMV WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. ON (B)(6) 2026, DURING A ROUTINE FOLLOW-UP AFTER STENT PLACEMENT, IT WAS FOUND THAT THE STENT HAD MIGRATED AND GOT STUCK IN THE SMALL BOWEL, CAUSING A PERFORATION. SURGERY WAS PERFORMED, AND THE STENT WAS EXPLANTED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS

  Patient problems: Bowel Perforation

  MAUDE report 24735941 ↗
• InjuryMar 18, 2026Device Stenosis

  BOSTON SCIENTIFIC BECAME AWARE OF AN EVENT INVOLVING AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM AND A WALLFLEX BILIARY RX UNCOVERED STENT THROUGH THE ARTICLE, PTBD-EDGE RENDEZVOUS FOR MALIGNANT BILIARY OBSTRUCTION AND AFFERENT LOOP SYNDROME IN SURGICALLY ALTERED ANATOMY AFTER FAILURE OF CONVENTIONAL APPROACHES, BY ESMA ZYNEP KIZILASLAN, ET AL. ACCORDING TO THE ARTICLE, A PERCUTANEOUS DRAIN WAS PLACED, AND THE AFFERENT LOOP WAS FILLED WITH WATER TO ENABLE ENDOSCOPIC ULTRASOUND-GUIDED GASTROENTEROSTOMY USING AN AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM. THROUGH THIS ACCESS, EDGE WITH PTBD RENDEZVOUS ALLOWED SUCCESSFUL PLACEMENT OF A WALLFLEX BILIARY RX UNCOVERED STENT FOR DEFINITIVE DECOMPRESSION. ELEVEN MONTHS LATER, THE STENT DYSFUNCTION FROM TUMOR INGROWTH AND WAS EFFECTIVELY TREATED WITH EDGE-ASSISTED INTRADUCTAL RADIOFREQUENCY ABLATION. PLEASE SEE THE REFERENCED ARTICLE FOR FULL DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24635100 ↗
• MalfunctionMar 9, 2026Break; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS INTENDED TO BE IMPLANTED TO TREAT AN ADVANCED CHOLANGIOCARCINOMA IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. THE PATIENT WAS A SIXTY-YEAR-OLD MALE WITH PREVIOUS DIAGNOSIS OF BILE DUCT CANCER AND BILE DUCT STENOSIS. DURING THE ATTEMPTED ERCP, THE PLAN WAS TO INSERT A METAL STENT FOR DECOMPRESSION AND DRAINAGE. AFTER PREPARING THE GUIDEWIRE AND SUCCESSFULLY INSERTING THE CATHETER, THE STENT WAS ADVANCED OVER THE GUIDEWIRE. HOWEVER, WHEN ATTEMPTING TO DEPLOY THE STENT, THE PUSHER COULD NOT BE ADVANCED OUT OF THE SHEATH NORMALLY. DESPITE REPEATED ATTEMPTS, THE STENT STILL COULD NOT BE DEPLOYED. UPON WITHDRAWAL, IT WAS FOUND THAT THE STENT WAS DAMAGED. ANOTHER WALLFLEX BILIARY STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24548049 ↗
• InjuryMar 4, 2026Use of Device Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX BILIARY STENT WAS TO BE IMPLANTED INTO THE BILE DUCT TO TREAT A BENIGN BILIARY STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2026. THE ANATOMY OF THE PATIENT WAS TORTUOUS AND WAS DILATED PRIOR TO THE PLACEMENT OF THE STENT. DURING THE PROCEDURE, RESISTANCE WAS ENCOUNTERED DURING THE DEPLOYMENT. AFTER THE STENT WAS FULLY DEPLOYED, IT WAS FOUND TO BE POSITIONED IN AN UNDESIRED LOCATION. DUE TO THIS, THE STENT WAS REMOVED FROM THE PATIENT USING FORCEPS. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE WALLFLEX BILIARY STENT WAS USED TO TREAT A BENIGN STRICTURE. HOWEVER, PER THE WALLFLEX BILIARY RX COVERED STENT SYSTEM INSTRUCTIONS FOR USE (IFU), THE STENT IS INDICATED FOR USE IN THE PALLIATIVE TREATMENT OF BILIARY STRICTURES PRODUCED BY MALIGNANT NEOPLASMS AND RELIEF OF MALIGNANT BILIARY OBSTRUCTION PRIOR TO SURGERY. THE DEVICE IS NOT INDICATED TO BE USED FOR THE TREATMENT OF BENIGN STRICTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24514519 ↗

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