WallFlex™ Esophageal M00516940Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729765288), received between Dec 4, 2018 and Nov 6, 2024 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-3285-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  PROCEDURE SUMMARY: IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A 3CM MALIGNANT STRICTURE DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. EVENT SUMMARY: DURING THE PROCEDURE, THE SECOND FLANGE WOULD NOT DEPLOY. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ESOPHAGEAL STENT. PATIENT STATUS: THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621083 ↗
• InjuryJul 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENTS WERE CONSECUTIVELY ATTEMPTED TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT AN OESOPHAGEAL STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE TIP OF THE STENTS DETACHED INSIDE THE PATIENT PRIOR TO DEPLOYMENT CONSECUTIVELY DURING EACH IMPLANT ATTEMPT. THE TIP OF THE FIRST TWO STENTS WERE NOT CONFIRMED TO BE RETRIEVED, WHILE THE TIP OF THE THIRD STENT WAS ABLE TO BE RETRIEVED WITH A ROTHNET. THE ORDER IN WHICH THE STENTS WERE USED WAS UNSPECIFIED. FINALLY, AN ULTRAFLEX ESOPHAGEAL STENT WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT, BUT THE PATIENT DID EXPERIENCE DISCOMFORT DUE TO THE EXTENDED DURATION OF THE PROCEDURE.

  Patient problems: Discomfort; Foreign Body In Patient

  MAUDE report 19706311 ↗
• InjuryJul 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO THREE OF THREE DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENTS WERE CONSECUTIVELY ATTEMPTED TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT AN OESOPHAGEAL STRICTURE DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE TIP OF THE STENTS DETACHED INSIDE THE PATIENT PRIOR TO DEPLOYMENT CONSECUTIVELY DURING EACH IMPLANT ATTEMPT. THE TIP OF THE FIRST TWO STENTS WERE NOT CONFIRMED TO BE RETRIEVED, WHILE THE TIP OF THE THIRD STENT WAS ABLE TO BE RETRIEVED WITH A ROTHNET. THE ORDER IN WHICH THE STENTS WERE USED WAS UNSPECIFIED. FINALLY, AN ULTRAFLEX ESOPHAGEAL STENT WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT, BUT THE PATIENT DID EXPERIENCE DISCOMFORT DUE TO THE EXTENDED DURATION OF THE PROCEDURE.

  Patient problems: Discomfort

  MAUDE report 19697299 ↗
• InjuryMay 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT STRICTURE DUE TO AN ESOPHAGEAL TUMOR DURING THE INSERTION OF AN ESOPHAGEAL STENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED SUCCESSFULLY; HOWEVER, IT WAS NOTICED IN THE FLUOROSCOPY THAT THE OLIVE TIP SEPARATED FROM THE DELIVERY SYSTEM. A GASTROSCOPE WAS INSERTED TO ATTEMPT THE REMOVAL OF THE DETACHED OLIVE TIP, BUT IT COULD NOT BE REMOVED. THE DETACHED OLIVE TIP WAS LEFT IN SITU WITH THE HOPE THAT IT WOULD DISLODGE ON ITS OWN. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19269916 ↗
• MalfunctionSep 19, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT ESOPHAGEAL STRICTURE DURING A GASTROSCOPY WITH ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, A 12CM WALLFLEX ESOPHAGEAL STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE PROXIMAL END OF THE STENT COULD NOT BE RELEASED FROM THE DELIVERY SYSTEM. THE STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM, AND THE PROCEDURE WAS COMPLETED WITH A 15CM WALLFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17776934 ↗
• InjuryJun 9, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 24, 2023 THAT A WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT STRICTURE POST RADIOTHERAPY TREATMENT DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY PLACED; HOWEVER, WHEN THE DELIVERY SYSTEM WAS REMOVED, THE INNER SHEATH WAS DETACHED AND WAS LODGED IN THE STENT. THE DETACHED INNER SHEATH WAS ATTEMPTED TO BE REMOVED WITH RAT-TOOTH FORCEPS AND PEDIATRIC FORCEPS BUT BOTH ATTEMPTS WERE UNSUCCESSFUL. THE STENT REMAINED IMPLANTED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. A DAY POST STENT PLACEMENT, X-RAY IMAGING WAS PERFORMED AND IT WAS NOTED THAT THE STENT'S FULL RADIAL EXPANSION RESULTED IN THE DETACHED INNER SHEATH FALLING INTO THE PATIENT'S STOMACH. THE DETACHED INNER SHEATH THAT FELL INTO THE STOMACH PASSED OUT NATURALLY FROM THE PATIENT. THE PATIENT WAS GOOD FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17097626 ↗
• MalfunctionOct 5, 2022Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS TO BE IMPLANTED TO TREAT AN ESOPHAGEAL CANCER DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2022. THE PATIENT'S ANATOMY WAS TORTUOUS. DURING THE PROCEDURE, WHEN THE WALLFLEX ESOPHAGEAL STENT WAS DEPLOYED, THE DELIVERY SYSTEM GOT BUCKLED/ACCORDIONED. THE WALLFLEX ESOPHAGEAL STENT WAS FULLY COVERED BY THE OUTER SHEATH WHEN IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE MEDIA ANALYSIS ON THE PHOTOS OF THE COMPLAINT DEVICE PROVIDED BY THE COMPLAINANT WHICH REVEALED THAT THE INNER SHEATH WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15543535 ↗
• InjuryMay 24, 2022Break; Difficult to Remove; Use of Device Problem; Break; Difficult to Remove; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ON (B)(6) 2022, 4 WEEKS POST STENT IMPLANT, THE STENT WAS ATTEMPTED TO BE REMOVED. DURING THE PROCEDURE, WHILE ATTEMPTING TO REMOVE THE STENT WITH GRASPING FORCEPS, THE STENT RETRIEVAL SUTURE BROKE AND THE STENT WAS UNABLE TO BE REMOVED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND THE PATIENT WAS SCHEDULED FOR ANOTHER STENT REMOVAL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE STENT WAS ATTEMPTED TO BE REMOVED 4 WEEKS POST IMPLANT. PER WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT SYSTEM INSTRUCTIONS FOR USE (IFU): "WARNING: STENT IS CONSIDERED TO BE A PERMANENT DEVICE. ONCE STENT PLACEMENT IS PERMANENTLY ACHIEVED, STENT REMOVAL OR REPOSITIONING IS NOT RECOMMENDED". THE USER DID NOT FOLLOW THE WARNING NOTED IN THE IFU. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14491481 ↗
• MalfunctionFeb 3, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS. ACCORDING TO THE COMPLAINANT, AFTER OPENING THE DEVICE PACKAGING AND UPON INSPECTION OUTSIDE THE PATIENT, IT WAS NOTICED THAT THE PLASTIC WHITE PIECE AT THE VERY FRONT OF THE STENT WAS DETACHED. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ESOPHAGEAL STENT OF A DIFFERENT SIZE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9660776 ↗
• InjuryMar 29, 2019Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 5, 2019 THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT HAS BEEN IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, ON AN UNKNOWN DATE, THE PATIENT CAME BACK DUE TO DYSPHAGIA. EGD PROCEDURE WAS PERFORMED AND NOTICED THAT THE STENT HAD MIGRATED APPROXIMATELY 1CM FROM THE TARGET LESION. REPORTEDLY, THE PHYSICIAN TRIED TO REMOVE THE STENT USING A RAT TOOTH FORCEPS BUT IT WAS NOT SUCCESSFUL. THE MIGRATED STENT REMAINS IMPLANTED AND ANOTHER WALLFLEX ESOPHAGEAL STENT WAS PLACED TO COMPLETE THE PROCEDURE. REPORTEDLY, THE STRICTURE HAD NOT RESOLVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S DYSPHAGIA WAS CONSIDERED RESOLVED.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 8466103 ↗
• InjuryFeb 1, 2019Material Deformation; Migration; Material Deformation; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 7, 2019, THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS IMPLANTED TO TREAT A MALIGNANT OBSTRUCTION IN THE ESOPHAGUS/STOMACH DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE STENT WAS PLACED 28 TO 30 CM FROM THE INCISORS. THE PATIENT'S TISSUE WAS FRIABLE. THE PATIENT UNDERWENT RADIATION/CHEMOTHERAPY POST STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018, THE PATIENT PRESENTED WITH PAIN ON THE LEFT SIDE, AND IT STARTED 10 TO 14 DAYS AGO. ON (B)(6) 2018, A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND SHOWED THE STENT HAD MIGRATED. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WAS ALSO PERFORMED AND CONFIRMED THE STENT HAD MIGRATED AND LODGED INTO THE FUNDUS. REPORTEDLY, THE STENT HAD ERODED THROUGH THE GASTRIC WALL AND INTO THE DIAPHRAGM AND LUNGS. THE STENT WAS REMOVED FROM THE PATIENT WITH AN ALLIGATOR FORCEPS, AND A CHEST TUBE WAS PLACED. REPORTEDLY, THE STENT WAS INTACT WHEN REMOVED, EXCEPT FOR DAMAGE OBSERVED DUE TO REMOVAL ON THE DISTAL END. REPORTEDLY, THE STRICTURE WAS RESOLVED AND THE PATIENT WAS IN A HOSPICE CARE.

  Patient problems: Erosion; No Code Available; Pain; Perforation

  MAUDE report 8296571 ↗
• InjuryDec 4, 2018Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS TO BE USED TO TREAT A 6 CM MALIGNANT STRICTURE DUE ESOPHAGEAL CANCER DURING AN ESOPHAGOGASTRODUODENOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS DEPLOYED IN THE ESOPHAGUS. HOWEVER, UNDER FLUOROSCOPY, IT WAS NOTICED THAT THE STENT SLIPPED INTO THE STOMACH LUMEN. THE STENT WAS REMOVED WITH A SNARE AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8130697 ↗