WallFlex™ Esophageal M00516930Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729765271), received between Feb 13, 2018 and Aug 7, 2026 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (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. 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-3284-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Activation, Positioning or Separation Problem

  It was reported to Boston Scientific Corporation that a Wallflex Partially Covered Esophageal Stent was to be implanted in the esophagus to treat an esophageal cancer during a gastroscopy procedure performed on (b)(6), 2026. The anatomy was not dilated prior to stent placement.During the procedure, it was noted that the distal end of the stent did not open. The stent was then removed partially deployed on the delivery system, 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 stable.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50184396 ↗
• MalfunctionMar 31, 2026Failure to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL STENT WAS ATTEMPTED TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A 6 CM LESION LOCATED 38 CM FROM THE INCISORS DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2026. THE PATIENT'S ANATOMY WAS DILATED FOLLOWING THE PLACEMENT ATTEMPT. DURING THE PROCEDURE, IT WAS OBSERVED THAT THE END OF THE DELIVERY SYSTEM WAS BENT. THE PHYSICIAN WAS UNABLE TO ADVANCE THE DEVICE THROUGH THE LESION AND SUBSEQUENTLY WITHDREW THE DELIVERY SYSTEM TO PERFORM DILATION. HOWEVER, THIS ATTEMPT WAS ALSO UNSUCCESSFUL. THE PROCEDURE WAS ULTIMATELY COMPLETED USING AN ALTERNATE METHOD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON MARCH 24, 2026, AND APRIL 08, 2026. THE TYPE OF PROCEDURE PERFORMED IS ESOPHAGOGASTRODUODENOSCOPY. THE ANATOMY OF THE PATIENT WAS TORTUROUS. THE PROCEDURE WAS COMPLETED BY DILATING THE ANATOMY OF THE PATIENT AND USING THE ORIGINAL DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24738579 ↗
• InjuryMay 10, 2023Migration; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT STRICTURE DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON (B)(6) 2023. DURING A SCHEDULED CHECK PER PROTOCOL POST-STENT PLACEMENT, THE STENT WAS NOTED TO HAVE MIGRATED INTO THE STOMACH. THE STENT WAS REMOVED FROM THE PATIENT USING FORCEPS, AND A NASOJEJUNAL (NJ) TUBE WAS PLACED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16902461 ↗
• MalfunctionMay 5, 2023Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023 THAT A WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT WAS USED TO TREAT A MALIGNANT ESOPHAGEAL TUMOR DURING A GASTROSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT PROCEDURE. DURING THE PROCEDURE, THERE WAS DIFFICULTY IN CROSSING PAST THE STRICTURE. WHEN THE DEVICE WAS REMOVED TO REASSESS, IT WAS NOTICED THAT THE FLEXIBLE TIP AT THE END OF THE STENT BECAME LOOSE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16881963 ↗
• InjuryDec 16, 2022Misassembled; Positioning Problem; Misassembled; Positioning Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF THE TWO DEVICES USED ON THE SAME PATIENT. REFER TO MANUFACTURER REPORT# 3005099803-2022-07566. FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A 6CM MALIGNANT STRICTURE DUE TO ESOPHAGEAL CANCER DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT ANATOMY WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE RO BAND MARKER WAS OBSERVED TO BE INCORRECTLY POSITIONED AND THE WALLFEX ESOPHAGEAL STENT (THE SUBJECT OF THIS REPORT) WAS DEPLOYED PROXIMAL TO THE STRICTURE. THE WALLFLEX ESOPHAGEAL STENT WAS REMOVED FROM THE PATIENT WITH RAT-TOOTH COMBO FORCEPS. A SECOND WALLFLEX ESOPHAGEAL STENT (3005099803-2022-07565) WAS OPENED, AND THE INNER STERILE POUCH WAS FOUND BROKEN. THE PROCEDURE WAS COMPLETED WITH A 3RD WALLFEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15999161 ↗
• InjuryAug 2, 2022Break; Difficult to Remove; Positioning Problem; Break; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED TO TREAT AN ESOPHAGEAL CANCER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT PROCEDURE. DURING THE PROCEDURE, THE STENT WAS DEPLOYED IN THE MOST DISTAL PART OF THE ESOPHAGUS. THE STENT COULD NOT BE REPOSITIONED AS THE BLUE RETRIEVAL SUTURE BROKE. THE STENT REMAINED IMPLANTED AND ANOTHER WALLFLEX ESOPHAGEAL STENT WAS PLACED 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 15153504 ↗
• InjuryJun 30, 2022Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A 4 CM MALIGNANT STENOSIS DUE TO ESOPHAGEAL CANCER DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE PERFORMED ON (B)(6) 2022. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED. HOWEVER, UNDER ENDOSCOPIC AND FLUOROSCOPIC VISUALIZATION, IT WAS NOTICED THAT THE DISTAL END OF THE STENT DID NOT OPEN. THE PHYSICIAN ATTEMPTED TO DILATE THE DISTAL FLANGE BUT STILL IT DID NOT EXPAND. THE STENT WAS REMOVED FROM THE PATIENT WITH RAT TOOTH FORCEPS AND ANOTHER WALLFLEX ESOPHAGEAL STENT WAS IMPLANTED 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 14874656 ↗
• InjuryApr 19, 2021Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 26, 2021 THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS TO BE IMPLANTED TO TREAT AN ESOPHAGEAL PERFORATION DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2021. THE PATIENT HAD A 2 MM PUNCTURE FROM EXTERNAL EROSION OF A GRANULOMA INTO THE ESOPHAGUS. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS SUCCESSFULLY DEPLOYED IN THE CORRECT LOCATION. HOWEVER, IT WAS NOTED THAT THE STENT DID NOT SEAL THE PERFORATION AND FLUID WAS GOING THROUGH THE STENT AND OUT THE ESOPHAGEAL PERFORATION. THE PHYSICIAN ATTEMPTED TO REPOSITION THE STENT BUT THERE STILL APPEARED TO BE A LEAK. THE STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS, AND ANOTHER WALLFLEX ESOPHAGEAL STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. REPORTEDLY, THE PHYSICIAN NOTICED A SMALL TEAR IN THE STENT COVER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: IT WAS REPORTED THAT THE WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS USED TO SEAL AN ESOPHAGEAL PERFORATION. PER WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT SYSTEM DIRECTIONS FOR USE (DFU),

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11686992 ↗
• InjuryAug 17, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS USED TO TREAT A 6CM MALIGNANT LESION IN THE ESOPHAGUS DURING A STENTING 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, DURING THE PROCEDURE, AFTER PLACING THE STENT NEAR THE GASTROESOPLAGEAL (GE) JUNCTION, IT WAS NOTED THAT THE STENT MIGRATED DOWNWARDS DESPITE PLACING TWO CLIPS ON THE STENT. THE STENT WAS REMOVED FROM THE PATIENT USING FORCEPS AND THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC STENT. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10417375 ↗
• InjuryJan 9, 2020Positioning Problem; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 17, 2019 THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS IMPLANTED TO TREAT A DISTAL OESOPHAGEAL CANCER LESION DURING A GASTROSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, THE STENT MIGRATED IMMEDIATELY AFTER DEPLOYMENT. THE PROXIMAL FLARE OF THE STENT WAS FOUND NEAR THE LESION WHILE THE DISTAL PORTION OF THE STENT WAS INSIDE THE STOMACH. THE POSITION OF THE STENT WAS ADJUSTED WITH FORCEPS AND SECURED WITH A RESOLUTION 360 CLIP. REPORTEDLY, THE PHYSICIAN WAS COMFORTABLE LEAVING THE STENT IN PLACE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9571918 ↗
• InjuryNov 26, 2019Break; Migration; Break; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 05, 2019 THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE IN THE ESOPHAGUS AND STOMACH DUE TO ADVANCED ESOPHAGEAL CANCER, DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS ALMOST OCCLUDED AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2019, THE PATIENT PRESENTED WITH DYSPHAGIA. AN IMAGING FOLLOWED BY EGD WAS PERFORMED AND NOTICED THE STENT HAD FULLY MIGRATED INTO THE STOMACH. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT BUT THE STENT RETRIEVAL LOOP BROKE AND THE STENT WAS NOT REMOVED. ON (B)(6) 2019, THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT FOR THE SECOND TIME WITH 2 RAT TOOTH FORCEPS, SNARES, RETRIEVAL HOOD AND AN OVERTUBE BUT STILL THE STENT WAS NOT REMOVED. REPORTEDLY, THE STENT BROKE AND THE STENT WIRES WERE EXPOSED. REPORTEDLY, THE STENT REMAINS IMPLANTED INSIDE THE PATIENT AND THERE IS NO PLAN TO REMOVE THE STENT DUE TO PATIENT'S HEALTH AND ADVANCED STATE OF CANCER.

  Patient problems: Dysphagia/ Odynophagia; No Code Available

  MAUDE report 9379264 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 05, 2019 THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT HAD BEEN IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE PATIENT PRESENTED WITH NAUSEA, DYSPHAGIA AND PAIN, POST STENT PLACEMENT. ON (B)(6) 2019, THE STENT WAS REMOVED FROM THE PATIENT. REPORTEDLY, THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE WITH NO COMPLICATIONS REPORTED. NOTE: DESPITE GOOD FAITH EFFORTS, BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Dysphagia/ Odynophagia; Nausea; No Code Available; Pain

  MAUDE report 9378250 ↗
• InjuryMar 27, 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 2 CM MALIGNANT STRICTURE IN THE GASTROESOPHAGEAL JUNCTION DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) 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 INTENTIONALLY DEPLOYED BUT ON AN INCORRECT LOCATION WHICH WAS TOO PROXIMAL TO THE STRICTURE. THE FULLY DEPLOYED STENT WAS REMOVED WITH THE USE OF GRASPING FORCEPS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ESOPHAGEAL STENT SUCCESSFULLY DEPLOYED ACROSS THE STRICTURE. 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 OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7375817 ↗
• InjuryFeb 13, 2018Difficult to Remove; Positioning Problem; Activation Failure; Difficult to Remove; Positioning Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT WAS IMPLANTED TO TREAT A 2 CM MALIGNANT STENOSIS NEAR THE PYLORUS DURING A STENT PLACEMENT 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, ACCESSING THE TARGET LOCATION WAS DIFFICULT DUE TO CURVATURES BUT THE PHYSICIAN WAS ABLE TO DEPLOY THE STENT. HOWEVER, IT WAS NOTED THAT THE STENT HAD NOT FULLY EXPANDED AND 1 CM OF THE STENOSIS WAS NOT COVERED BY THE STENT. DURING THE REMOVAL OF THE DELIVERY SYSTEM, THE STENT GOT CAUGHT ON THE DELIVERY SYSTEM AND THE STENT WAS PULLED OUT OF POSITION. THE PHYSICIAN SUCCESSFULLY REMOVED THE STENT USING A BIOPSY FORCEPS. THE PHYSICIAN DECIDED TO STOP THE PROCEDURE AND PLAN TO PERFORM ANOTHER STENT PLACEMENT USING A DIFFERENT DEVICE. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7267232 ↗