WallFlex™ Esophageal M00516720Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729778059), received between Nov 15, 2017 and Mar 5, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Aug 1, 2024Open, Classified

   WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

   Z-3277-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 5, 2026Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL STENT WAS INTENDED TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A 10 CM ESOPHAGEAL STRICTURE CAUSED BY CANCER DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2026. THE ANATOMY OF THE PATIENT WAS TORTUROUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING PROCEDURE, THE PHYSICIAN ADVANCED THE WIRE ACROSS THE STRICTURE AND PERFORMED A CONTROLLED RADIAL EXPANSION (CRE) 10 MM TO 12 MM TO DILATE THE STRICTURE SO STENT COULD EASILY CROSS. POST DILATION, THE WALL FLEX ESOPHAGEAL FULLY COVERED STENT WAS LOADED ON THE WIRE AND PLACED ACROSS THE STRICTURE. THE STRICTURE WAS TIGHT WHICH CAUSED THE STENT NOT TO OPEN. THE PHYSICIAN TRIED MULTIPLE ATTEMPTS BUT STILL WAS NOT ABLE TO DEPLOY THE STENT. WHEN THE STENT WAS REMOVED FROM THE PATIENT, THE STENT REMAINED FULLY COVERED BY THE OUTER SHEATH. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE IS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24519565 ↗
• MalfunctionSep 25, 2025Activation, Positioning or Separation Problem; Material Integrity Problem; Activation, Positioning or Separation Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL STENT WAS TO BE USED IN THE ESOPHAGUS TO TREAT ESOPHAGEAL STENOSIS DURING AN ENDOSCOPIC ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. PRIOR TO PROCEDURE, IT WAS REPORTED THAT THE TIP OF THE STENT COVER WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23145799 ↗
• MalfunctionNov 4, 2021Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. POST STENT PLACEMENT, THE PATIENT EXPERIENCED DISCOMFORT AND IMAGING WAS PERFORMED. IT WAS NOTED THAT THE STENT MIGRATED. REPORTEDLY, THE STENT REMAINS IMPLANTED AND THE PHYSICIAN WAS COMFORTABLE LEAVING THE STENT IMPLANTED. THERE ARE NO KNOWN TREATMENTS OR INTERVENTIONS FOR THE PATIENT'S DISCOMFORT.

  Patient problems: Discomfort

  MAUDE report 12752257 ↗
• MalfunctionOct 30, 2020Unsealed Device Packaging; Material Deformation; Unsealed Device Packaging; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS RECEIVED DAMAGED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE DEVICE WAS RECEIVED DAMAGED AND IT WAS NOTICED THAT THE OUTER AND INNER PACKAGING WERE DAMAGED. THE INNER STERILE POUCH WAS COMPROMISED AND THE DELIVERY SYSTEM WAS KINKED. REPORTEDLY, THE DAMAGE APPEARED TO BE FROM SHIPPING. REPORTEDLY, THERE WAS NO PATIENT OR PROCEDURE INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 10762475 ↗
• MalfunctionApr 29, 2019Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT A FISTULA IN ESOPHAGOGASTRIC ANASTOMOSIS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, ON APRIL 08, 2019 DURING A STENT REMOVAL PROCEDURE, THE STENT RETENTION SUTURE BROKE WHILE TRYING TO REMOVE THE STENT OUT FROM THE PATIENT. THE STENT WAS SUCCESSFULLY REMOVED BY GRASPING IT FROM THE STENT WALL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. DESPITE NUMEROUS ATTEMPTS, BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NOTE: ACCORDING TO THE COMPLAINANT, THE WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS PLACED FOR FISTULA IN ESOPHAGOGASTRIC ANASTOMOSIS. HOWEVER, PER WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM DIRECTIONS FOR USE, THE STENT IS INDICATED FOR MAINTAINING ESOPHAGEAL LUMINAL PATENCY IN ESOPHAGEAL STRICTURES CAUSED BY INTRINSIC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8562556 ↗
• MalfunctionApr 29, 2019Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT A FISTULA IN ESOPHAGO-JEJUNAL ANASTOMOSIS IN THE ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2019, THE FISTULA HAD RESOLVED AND DURING A PLANNED STENT REMOVAL PROCEDURE, THE STENT RETENTION SUTURE BROKE WHILE TRYING TO REMOVE THE STENT OUT FROM THE PATIENT. THE STENT WAS SUCCESSFULLY REMOVED BY GRASPING IT FROM THE STENT WALL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ACCORDING TO THE COMPLAINANT, THE WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS PLACED FOR FISTULA IN AN ESOPHAGO-JEJUNAL ANASTOMOSIS. HOWEVER, PER WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM DIRECTIONS FOR USE, THE STENT IS CONTRAINDICATED FOR PLACEMENT IN AN ESOPHAGO-JEJUNOSTOMY (FOLLOWING GASTRECTOMY), AS PERISTALSIS AND ALTERED ANATOMY MAY DISPLACE STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8562554 ↗
• MalfunctionApr 29, 2019Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT A FISTULA IN ESOPHAGOGASTRIC ANASTOMOSIS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2019 DURING A STENT REMOVAL PROCEDURE, THE STENT RETENTION SUTURE BROKE WHILE TRYING TO REMOVE THE STENT OUT FROM THE PATIENT. THE STENT WAS SUCCESSFULLY REMOVED BY GRASPING IT FROM THE STENT WALL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. DESPITE NUMEROUS ATTEMPTS, BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NOTE: ACCORDING TO THE COMPLAINANT, THE WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS PLACED FOR FISTULA IN ESOPHAGOGASTRIC ANASTOMOSIS. HOWEVER, PER WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM DIRECTIONS FOR USE, THE STENT IS INDICATED FOR MAINTAINING ESOPHAGEAL LUMINAL PATENCY IN ESOPHAGEAL STRICTURES CAUSED BY INTRINSIC AN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8562551 ↗
• InjuryMar 14, 2019Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE USED TO TREAT A TUMOR IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED. ANGIOGRAPHY WAS PERFORMED AND NOTICED THE STENT HAD MIGRATED DURING THE FIRST IMPLANTATION. THE STENT WAS REMOVED WITH FORCEPS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ESOPHAGEAL FULLY COVERED STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8421820 ↗
• InjuryNov 15, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE USED TO TREAT A MALIGNANT ESOPHAGEAL STENOSIS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN PLACED THE PATIENT UNDER COMPLETE SEDATION BEFORE INTRODUCING THE STENT DELIVERY SYSTEM. AS THE STENT DELIVERY SYSTEM WAS BEING INSERTED INTO THE ESOPHAGUS, THE PATIENT COUGHED. THE PHYSICIAN REMOVED THE DELIVERY SYSTEM FROM THE PATIENT BUT THE CONTRAST MEDIA WAS ASPIRATED INTO THE LUNGS. REPORTEDLY, THE PHYSICIAN TOOK ¿EMERGENCY MEASURES¿ TO RESOLVE THE ASPIRATION AND PLANS TO IMPLANT ANOTHER STENT. THE PATIENT¿S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Aspiration/Inhalation

  MAUDE report 7034500 ↗