WallFlex EsophagealRecalls & reported problems across all models

We found 12 models of WallFlex Esophageal by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 175 adverse event reports in the FDA's MAUDE database, received between Feb 22, 2017 and Sep 29, 2026 — classified as 3 deaths, 120 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Positioning Problem” (44 reports).

12 FDA recall records name at least one of these models by its device identifier, 12 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. 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 Esophageal 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 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-3286-2024 · Root cause: Process control · Recall details · FDA record ↗

2. 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 ↗

3. 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 · Recall details · FDA record ↗

4. 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-3283-2024 · Root cause: Process control · Recall details · FDA record ↗

5. 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-3282-2024 · Root cause: Process control · Recall details · FDA record ↗

6. 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 · Recall details · FDA record ↗

7. 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-3280-2024 · Root cause: Process control · Recall details · FDA record ↗

8. 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-3279-2024 · Root cause: Process control · Recall details · FDA record ↗

9. 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-3278-2024 · Root cause: Process control · Recall details · FDA record ↗

10. 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 · Recall details · FDA record ↗

11. 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-3276-2024 · Root cause: Process control · Recall details · FDA record ↗

12. 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-3275-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported WallFlex Esophageal problems

WallFlex Esophageal models

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

• WallFlex™ Esophageal M00516730

  PROSTHESIS, ESOPHAGEAL
  1 recall29 reports
• WallFlex™ Esophageal M00516740

  PROSTHESIS, ESOPHAGEAL
  1 recall1 death22 reports
• WallFlex™ Esophageal M00516750

  PROSTHESIS, ESOPHAGEAL
  1 recall1 death19 reports
• WallFlex™ Esophageal M00516700

  PROSTHESIS, ESOPHAGEAL
  1 recall18 reports
• WallFlex™ Esophageal M00516910

  PROSTHESIS, ESOPHAGEAL
  1 recall15 reports
• WallFlex™ Esophageal M00516930

  PROSTHESIS, ESOPHAGEAL
  1 recall14 reports
• WallFlex™ Esophageal M00516710

  PROSTHESIS, ESOPHAGEAL
  1 recall13 reports
• WallFlex™ Esophageal M00516940

  PROSTHESIS, ESOPHAGEAL
  1 recall12 reports
• WallFlex™ Esophageal M00516900

  PROSTHESIS, ESOPHAGEAL
  1 recall11 reports
• WallFlex™ Esophageal M00516950

  PROSTHESIS, ESOPHAGEAL
  1 recall1 death9 reports
• WallFlex™ Esophageal M00516720

  PROSTHESIS, ESOPHAGEAL
  1 recall9 reports
• WallFlex™ Esophageal M00516920

  PROSTHESIS, ESOPHAGEAL
  1 recall4 reports

Recent WallFlex Esophageal adverse event reports

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

• MalfunctionSep 29, 2026Activation, Positioning or Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940788 ↗
• 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 ↗
• MalfunctionAug 3, 2026Device Contamination with Chemical or Other Material

  It was reported to Boston Scientific Corporation that a WallFlex Esophageal Stent was to be implanted in the esophagus during an esophageal stent placement procedure performed on (b)(6)2026.During the preparation prior to the procedure, the stent was opened and a white string was observed exiting the distal cap directly out of the box. The device was not used, and another WallFlex Esophageal Stent was used to complete the procedure.There were no patient complications as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50112134 ↗
• 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 ↗
• 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 ↗
• InjuryNov 20, 2025Difficult to Remove; Device-Device Incompatibility; Positioning Problem; Difficult to Remove; Device-Device Incompatibility; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED IN THE GASTROESOPHAGEAL JUNCTION TO TREAT A MALIGNANT DISTAL STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE ESOPHAGEAL STENT WAS SUCCESSFULLY DEPLOYED. HOWEVER, THE PHYSICIAN DROVE A GASTROSCOPE THROUGH THE STENT CAUSING IT TO DISLODGE DISTALLY INTO THE STOMACH. THE PROCEDURE WAS PROLONGED FOR APPROXIMATELY 1 HOUR AS ATTEMPTS TO RETRIEVE THE STENT USING SNARES AND RAT TOOTH FORCEPS WERE MADE. DESPITE THE EFFORTS, THE DEVICE WAS NOT ABLE TO BE RETRIEVED; THE PHYSICIAN IS GOING TO SCHEDULE A FUTURE PROCEDURE TO REMOVE IT EVENTUALLY. THE PROCEDURE WAS COMPLETED BY IMPLANTING ANOTHER WALLFLEX STENT. THE PATIENT'S CONDITION WAS STABLE AFTER THE PROCEDURE. 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 23607546 ↗
• InjuryNov 13, 2025Positioning Problem; Activation Failure; Positioning Problem; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT AN ESOPHAGEAL STRICTURE DURING A PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS NOT TORTUOUS OR TIGHT PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED IN THE ESOPHAGUS WITH THE DISTAL END POSITIONED IN THE STOMACH. UNDER FLUOROSCOPIC OBSERVATION, IT APPEARED THAT THE DISTAL END OF THE STENT FAILED TO FULLY EXPAND. THE PHYSICIAN ATTEMPTED TO RECONSTRAIN THE CATHETER; HOWEVER, THE TIP OF THE DELIVERY SYSTEM ENGAGED THE STENT, CAUSING IT TO MIGRATE PROXIMALLY. GRASPING FORCEPS WERE THEN USED TO REPOSITION THE STENT, AT WHICH POINT IT APPEARED THAT THE STENT HAD FULLY EXPANDED. THE PROCEDURE WAS COMPLETED WITH THE MIGRATED STENT REMAINING IN PLACE, AND IT WAS REPORTED THAT THE STENT WILL BE REMOVED AT A LATER DATE. 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 23543367 ↗
• InjuryOct 3, 2025Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT ESOPHAGEAL CANCER WITH 7CM LESION DURING A PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, STENT DISPLACEMENT WAS OBSERVED. IT WAS NOTED THAT THE STENT WAS IMPLANTED IN THE CORRECT POSITION; HOWEVER, THE PATIENT REPORTED DISCOMFORT, AND THE STENT WAS FOUND TO BE SHIFTED. SUBSEQUENTLY, THE STENT WAS REMOVED USING SNARES. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME MODEL. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 8, 2025 AND OCTOBER 20, 2025: IT WAS LATER CONFIRMED THAT THE STENT WAS IMPLANTED ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT EXPERIENCED DISCOMFORT, AND THE MIGRATED STENT WAS CONFIRMED VIA IMAGING.

  Patient problems: Discomfort

  MAUDE report 23215969 ↗
• 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 ↗
• 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 ↗
• InjuryAug 13, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED TO TREAT AN MALIGNANCY IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE. THE PATIENT, WHO HAD A STENT PLACED TWO WEEKS AGO FOR MALIGNANT OBSTRUCTION, UNDERWENT FOLLOW-UP ENDOSCOPY. DURING THE PROCEDURE, THE PHYSICIAN IDENTIFIED EARLY TISSUE INGROWTH AT THE STENT SITE, WHICH WAS CONCERNING GIVEN THE SHORT TIME SINCE PLACEMENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798609 ↗
• InjuryAug 7, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED TO TREAT A MALIGNANT TUMOR IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT COVER BROKE POST-DEPLOYMENT, CAUSING THE TISSUE TO SQUEEZE THE MESH INTO THE STENT WHILE THE STENT COVER REMAINED ATTACHED. SUBSEQUENTLY, THE STENT WAS REMOVED USING SNARES. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT OF THE SAME MODEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION ON SEPTEMBER 27, 2025: IT WAS LATER CONFIRMED THAT THE TUMOR IS MALIGNANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22745370 ↗
• InjuryMay 27, 2025Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE WALLFLEX ESOPHAGEAL STENTS WAS TO BE IMPLANTED TO MALIGNANT STRICTURE DURING A GASTROSCOPY WITH ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE STENT WAS PLACED AND WAS DEPLOYED DISTALLY BEYOND THE STRICTURE. THE STENT WAS DIFFICULT TO REMOVE AS THE STRICTURE WAS TOO TIGHT. THE PROCEDURE COMPLETED USING AN ALTERNATE DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22091398 ↗
• InjuryMar 13, 2025Positioning 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 STENT WAS IMPLANTED TO TREAT AN ESOPHAGEAL STENOSIS IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE CONICAL TIP OF THE STENT WAS DETACHED, RESULTING IN THE FAILURE OF SUBSEQUENT IMPLANTATION AND THE NEED FOR GASTROSCOPY TO REMOVE THE CONICAL TIP. THE PROCEDURE WAS NOT COMPLETE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ADDITIONAL INFORMATION RECEIVED ON APRIL 23, 2025. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED ON (B)(6) 2025, WITH A NON-BOSTON SCIENTIFIC DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21597184 ↗
• MalfunctionMar 7, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A STRICTURE CAUSED BY CANCER DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, IT WAS NOTICED THAT THE STENT HAD MULTIPLE PUNCTURES IN IT. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATION REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 27, 2025. IT WAS REPORTED THAT THE WALLFLEX ESOPHAGEAL STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A 3CM MALIGNANT STRICTURE. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, IT WAS NOTED THAT THE LINING OF THE STENT WAS PUNCTURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21554024 ↗

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