WallFlex™ Esophageal M00516900Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 08714729765240), received between Mar 7, 2018 and Sep 3, 2025 — classified as 7 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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-3281-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL STENT WAS USED TO TREAT A 7CM MALIGNANT ESOPHAGEAL STRICTURE IN THE ESOPHAGUS DURING A METAL STENTING PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS VERY TIGHT AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE PHYSICIAN TRIED TO OPEN THE STENT MULTIPLE TIMES, BUT IT FAILED TO DEPLOY. CONSEQUENTLY, THE PROCEDURE WAS CANCELLED. NO FURTHER PROCEDURES ARE PLANNED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22958022 ↗
• MalfunctionJan 16, 2025Failure to Advance; Activation, Positioning or Separation Problem; Failure to Advance; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL STENT WAS TO BE USED TO TREAT AN IMPASSABLE ESOPHAGEAL CANCER DURING A PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE. THE DEVICE COULD NOT PASS THROUGH THE TUMOUR. THE DEVICE WAS REMOVED WAS THEN REMOVED FROM THE PATIENT. UPON INSPECTION, IT WAS NOTED THAT THE TIP OF THE DELIVERY SYSTEM WAS SLIGHTLY SEPARATED FROM THE SHEATH. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21172058 ↗
• InjuryJun 21, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS IMPLANTED DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT HAD MOVED OUT OF ITS POSITION. THE STENT REMAINS IMPLANTED, AND ANOTHER WALLFLEX ESOPHAGEAL STENT WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19586478 ↗
• InjuryMay 22, 2024Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; 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 AN ESOPHAGEAL STRICTURE DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, THERE WAS SOME RESISTANCE UPON WITHDRAWAL OF THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS REMOVED, AND IT WAS NOTED THAT THE TIP WAS MISSING. THE TIP WAS FOUND INSIDE THE STENT VIA X-RAY. THE PHYSICIAN THEN USED A PAIR OF FORCEPS THROUGH THE SCOPE TO PUSH THE DETACHED TIP INTO THE PATIENT'S STOMACH. IN THE PHYSICIAN'S ASSESSMENT, THE TIP WOULD JUST PASS NATURALLY OUT OF THE PATIENT. THE STENT REMAINS IMPLANTED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 19377259 ↗
• MalfunctionApr 16, 2024Positioning 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 IN THE ESOPHAGUS TO TREAT AN ESOPHAGEAL CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS NOT ABLE TO BE DEPLOYED, AND IT WAS NOTED THAT THE WHITE DISTAL TIP WAS INSIDE THE PATIENT'S ESOPHAGUS UNDER PEDIATRIC GASTROSCOPE. THE GUIDEWIRE WAS THEN REMOVED, AND THE WHITE DISTAL TIP CAME OUT WITH THE WIRE. A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19118250 ↗
• InjuryJan 24, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JANUARY 03, 2023, THAT A WALLFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED TO TREAT A STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE WALLFLEX ESOPHAGEAL STENT WAS FULLY DEPLOYED; HOWEVER, IT WAS NOTED THAT THE STENT COVER WAS TORN. THE WALLFEX ESOPHAGEAL STENT WAS REMOVED FROM THE PATIENT WITH RAT TOOTH FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16233243 ↗
• InjurySep 6, 2022Obstruction of Flow; Migration; Obstruction of Flow; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX ESOPHAGEAL STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT STRICTURE DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. ON (B)(6) 2021, POST STENT PLACEMENT, THE PATIENT PRESENTED WITH DYSPHAGIA AND HEMATEMESIS. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WAS PERFORMED AND IT WAS FOUND THAT THE WALLFLEX ESOPHAGEAL STENT HAD OCCLUSION, PROXIMAL OVERGROWTH AND HAD MIGRATED DISTALLY. THE WALLFLEX ESOPHAGEAL STENT REMAINED IMPLANTED AND ANOTHER PARTIALLY COVERED ESOPHAGEAL STENT WAS PLACED MORE PROXIMAL TO BRIDGE THE AFFECTED AREA AND THE PROCEDURE WAS COMPLETED. ON AN UNKNOWN DATE, THE PATIENT PASSED AWAY AND THE WALLFLEX ESOPHAGEAL STENT WAS BURIED WITH PATIENT.

  Patient problems: Dysphagia/ Odynophagia; Hematemesis

  MAUDE report 15362124 ↗
• InjurySep 9, 2020Obstruction of Flow; Migration; Obstruction of Flow; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON AUGUST 18, 2020 THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS IMPLANTED TO TREAT A 5CM MALIGNANT STRICTURE IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2020, THE PATIENT EXPERIENCED DYSPHAGIA. THE PHYSICIAN PERFORMED AN ENDOSCOPIC EXAM AND CONFIRMED THAT THE STENT MIGRATED AND THERE WAS TISSUE INGROWTH. THE STENT REMAINS IMPLANTED AND THE PHYSICIAN WAS COMFORTABLE LEAVING THE STENT IN PLACE. ON (B)(6) 2020, A WALLFLEX FULLY COVERED ESOPHAGEAL STENT WAS IMPLANTED INSIDE THE ORIGINAL STENT. REPORTEDLY, THE PATIENT WILL BE RE-SCHEDULED FOR ESOPHAGECTOMY TO POSSIBLY REMOVE THE STENT. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE FINE. IN THE PHYSICIAN'S ASSESSMENT THE RELATIONSHIP BETWEEN THE DYSPHAGIA AND THE STENT WAS THE TISSUE INGROWTH.

  Patient problems: Dysphagia/ Odynophagia; No Code Available

  MAUDE report 10511556 ↗
• MalfunctionFeb 27, 2020Failure to Advance; Material Integrity Problem; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS TO BE USED TO TREAT A MALIGNANT STENOSIS IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE COULD NOT CROSS THE LESION. 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. NOTE: THIS EVENT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON INVESTIGATION RESULT WHICH REVEALED THE TIP WAS KINKED (DAMAGED).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9763496 ↗
• InjuryApr 25, 2019Adverse 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) 2019 THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT HAD BEEN IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE DISTAL ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. AFTER STENT PLACEMENT, THE PATIENT'S CANCER WAS TREATED WITH CHEMOTHERAPY AND RADIATION. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2019, THE PATIENT PRESENTED WITH PAIN, NAUSEA AND REGURGITATION. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE WAS PERFORMED TO EXAMINE THE STENT, AND DURING THE PROCEDURE, IT WAS OBSERVED THAT THE STENT WAS PATENT AND APPEARED TO BE IN GOOD POSITION. THE STENT REMAINS IMPLANTED AND THE PHYSICIAN DIDN'T NOTE ANY ISSUES WITH THE STENT. PER THE PHYSICIAN, THE PATIENT'S PAIN WAS NOT RELATED TO THE STENT AND THE PATIENT DIDN'T HAVE ANY CHANGE IN PAIN RELATED TO THE STENT. IN THE PHYSICIAN'S OPINION, THE NAUSEA AND VOMITING WERE PROBABLY DUE TO UNCONTROLLED REFLUX POST STENT PLACEMENT. THE PATIENT WAS TREATED WITH ZOFRAN, REGLAN AND A HIGH DOSE OF PPI (PROTON PUMP INHIBITOR) TO RELIEVE NAUSEA AND VOMITING AS PRESCRIBED BY THE PHYSICIAN. REPORTEDLY, THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE FINE BUT THE NAU

  Patient problems: Nausea; Vomiting

  MAUDE report 8550890 ↗
• InjuryMar 7, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 13, 2018 THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE OF THE DISTAL ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018, THE PATIENT PRESENTED WITH ABDOMINAL PAIN AND INCREASED DYSPHAGIA. AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WAS PERFORMED AND SHOWED THAT THE STENT HAD MIGRATED DISTALLY IN THE ESOPHAGUS. IN THE PHYSICIAN'S ASSESSMENT, THE RELATIONSHIP BETWEEN THE STENT PLACEMENT AND THE ABDOMINAL PAIN IS UNKNOWN, BUT THE STENT CONTRIBUTED TO THE PATIENT'S DYSPHAGIA. THE STENT WAS REMOVED FROM THE PATIENT USING FORCEPS ON (B)(6) 2018. REPORTEDLY, THE PATIENT HAD RADIATION TREATMENT AND CHOSE NOT TO HAVE A NEW STENT IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AFTER THE STENT WAS EXPLANTED. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Abdominal Pain; Dysphagia/ Odynophagia

  MAUDE report 7321529 ↗