WallFlex™ Esophageal M00516710Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 08714729778042), received between Feb 22, 2017 and Mar 7, 2025 — classified as 8 injuries, 5 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. 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-3276-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionDec 9, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL STENT WAS USED TO TREAT A MALIGNANT ESOPHAGEAL STRICTURE DURING A METAL STENTING PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS VERY TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS UNABLE TO BE DEPLOYED. THE STENT WAS REMOVED FROM THE PATIENT FULLY COVERED BY THE OUTER SHEATH. THE PROCEDURE WAS NOT COMPLETED DUE TO MALIGNANT STRICTURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20885872 ↗
• MalfunctionNov 28, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS INTENDED TO TREAT AN 8 CM MALIGNANT ESOPHAGEAL STENOSIS DURING A PAINLESS ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, IT WAS NOTICED THAT THE DELIVERY SHAFT WAS STUCK, MAKING THE STENT DIFFICULT TO DEPLOY. THE STENT WAS REMOVED FROM THE PATIENT WHILE PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20807180 ↗
• InjuryMay 17, 2024Detachment of Device or Device Component; Positioning Problem; Detachment of Device or Device Component; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT STRICTURE DURING AN ESOPHAGOGASTRODUODENOSCOPY 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 ATTEMPTED TO BE DEPLOYED. HOWEVER, THE TIP WAS NOTED TO BE DETACHED INSIDE THE PATIENT UNDER FLUOROSCOPY, AND THE STENT WAS MOVED OUT OF ITS POSITION. THE DETACHED TIP WAS REMOVED USING FORCEPS. THE STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JUNE 18, 2024. IT WAS REPORTED THAT THE PROCEDURE WAS NOT COMPLETED DUE TO NO OTHER DEVICE WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19341059 ↗
• MalfunctionMay 6, 2024Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH ESOPHAGEAL 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 WALLFLEX ESOPHAGEAL STENT WAS INTRODUCED OVER THE GUIDEWIRE BUT WAS NOT PASSING EASILY, AND THE WHITE RUBBER TIP DETACHED FROM THE DELIVERY SYSTEM INSIDE THE PATIENT. THE PHYSICIAN DECIDED TO LEAVE THE DETACHED WHITE RUBBER TIP INSIDE THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19249617 ↗
• InjuryApr 24, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2023, THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED IN THE ESOPHAGUS TO TREAT AN ESOPHAGOTRACHEAL FISTULA DURING AN ESOPHAGEAL STENT IMPLANTATION PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE STENT HAD BEEN IMPLANTED FOR ONE MONTH. ON (B)(6) 2023, DURING THE PATIENT'S REVIEW, IT WAS NOTED THAT THE IMPLANTED WALLFLEX ESOPHAGEAL STENT HAD LAMINATING HOLES ON THE STENT COVER. THE STENT WAS REMOVED FROM THE PATIENT WITH PINCERS. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE; A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED BY THE COMPLAINANT AND SHOWED THE STENT WAS OUTSIDE THE PATIENT WITH HOLES ON THE STENT COVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16801324 ↗
• MalfunctionJan 13, 2023Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022, THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS TO TREAT A MALIGNANT STRICTURE DUE TO ESOPHAGEAL CANCER DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TIGHT BUT NOT TORTUOUS. DURING THE PROCEDURE, WHILE INSERTING THE WALLFLEX ESOPHAGEAL STENT OVER THE GUIDEWIRE, THE WHITE OLIVE TIP WAS NOTED TO HAVE SEPARATED FROM THE DELIVERY CATHETER. DEPLOYMENT WAS STILL ATTEMPTED, BUT THE WALLFLEX ESOPHAGEAL STENT DID NOT DEPLOY. THE WHITE OLIVE TIP WAS REMOVED TOGETHER WITH THE DELIVERY SYSTEM, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED BY THE COMPLAINANT AND SHOWED THE WHITE OLIVE TIP WAS DETACHED FROM THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16158102 ↗
• InjuryJun 11, 2019Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT HAS BEEN IMPLANTED TO TREAT A 2-3CM ANASTOMOTIC STRICTURE POST ESOPHAGECTOMY WITH A MALIGNANT EXTRINSIC MASS COMPRESSING THE ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2019. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, THE STENT MOVED TO THE PATIENT'S STOMACH AS SEEN UNDER FLUOROSCOPY. THE STENT WAS ATTEMPTED TO BE REMOVED BY THE STENT REMOVAL SUTURE, BUT THE PHYSICIAN COULD NOT PULL THE STENT PAST THE STRICTURE. REPORTEDLY, THE STENT WAS LEFT IN THE DISTAL ESOPHAGUS AND ANOTHER WALLFLEX ESOPHAGEAL STENT WAS IMPLANTED THROUGH THE MIGRATED STENT TO BRIDGE THE STRICTURE. 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 GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8688483 ↗
• InjuryOct 18, 2018Difficult to Remove; Migration; Difficult to Remove; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON SEPTEMBER 27, 2018 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO TREAT AN 8 CM MALIGNANT STRICTURE IN THE DISTAL ESOPHAGUS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE STENT WAS IMPLANTED AT (B)(6) MEDICAL CENTER (B)(6). THE PATIENT'S ANATOMY WAS NOT TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE RADIATION /CHEMOTHERAPY DURING THE TIME FOLLOWING STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2018, X-RAY WAS PERFORMED BY ANOTHER FACILITY AND FOUND THE STENT HAD MIGRATED INTO THE STOMACH. REPORTEDLY, ON THE SAME DAY, THE PATIENT WAS BROUGHT BACK TO (B)(6) MEDICAL CENTER (B)(6) AND REMOVAL OF THE STENT WAS ATTEMPTED BUT WITHOUT SUCCESS. AS PER THE PHYSICIAN, STENT MIGRATION WAS NOT DUE TO STRICTURE RESOLUTION. REPORTEDLY, THE PHYSICIAN WAS COMFORTABLE LEAVING THE STENT IN PLACE AND HAS NO PLAN TO REMOVE THE STENT. 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 7981720 ↗
• InjurySep 14, 2018Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2018 THAT A WALLFLEX FULLY COVERED ESOPHAGEAL STENT WAS IMPLANTED TO TREAT A STRICTURE IN THE ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, POST STENT PLACEMENT, THE PATIENT EXPERIENCED DISCOMFORT. ON (B)(6) 2018, DURING AN ESOPHAGOGASTRODUODENOSCOPY WITH STENT REMOVAL PROCEDURE, THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT USING A RAT TOOTH FORCEPS HOWEVER THE RETRIEVAL SUTURE BROKE DURING AN ATTEMPTED STENT REMOVAL. THE STENT REMAINS IMPLANTED AND THE PROCEDURE WAS NOT COMPLETED. REPORTEDLY, THE PATIENT WAS REFERRED TO ANOTHER FACILITY.

  Patient problems: Discomfort

  MAUDE report 7876994 ↗
• InjuryAug 7, 2018Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 18, 2018 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE USED TO TREAT A 5 CENTIMETER MALIGNANT STRICTURE IN THE DISTAL ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. REPORTEDLY, THE PATIENT'S ANATOMY WAS TIGHT AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, THE STENT WAS DIFFICULT TO DEPLOY, FORCE WAS APPLIED TO OPEN THE STENT AND DUE TO THE SPEED/FORCE APPLIED DURING DEPLOYMENT THE STENT WAS INCORRECTLY PLACED. THE STENT WAS REMOVED WITH RAT TOOTH FORCEPS AND A DIFFERENT SIZE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7759106 ↗
• InjuryJul 17, 2018Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(4) 2018 THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS TO BE USED TO TREAT A 1.5 CM SMALL LEAK OCCLUSION OF CONCURRENT ESOPHAGEAL FISTULA IN THE LOWER ESOPHAGEAL SPHINCTER OF THE GASTROESOPHAGEAL JUNCTION DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT DILATED PRIOR TO THE STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE STENT WAS PREMATURELY DEPLOYED AT AN INCORRECT LOCATION. THE STENT WAS REMOVED WITH RAT TOOTH GRASPING FORCEPS AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7696350 ↗
• InjuryFeb 22, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT A WALLFLEX ESOPHAGEAL STENT WAS USED IN THE ESOPHAGUS DURING ESOPHAGOGASTRODUODENOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN STARTED DEPLOYING THE STENT WHEN THE OUTER SHEATH CRACKED. THE STENT SEPARATED FROM THE CATHETER, CAME OUT OF THE CRACKED SHEATH, AND BROKE IN TWO PIECES. THE BROKEN STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6350637 ↗