WallFlex™ Esophageal M00516950Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729765295), received between Aug 24, 2017 and Aug 3, 2026 — classified as 1 death, 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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-3286-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

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

  NOTE: THIS REPORT PERTAINS TO TWO 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 19698352 ↗
• DeathJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED ON THE SAME PATIENT. REFER TO MANUFACTURER REPORT # 3005099803-2023-06992 AND 3005099803-2023-06993 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2023. ON (B)(6) 2023, A SECOND WALLFLEX ESOPHAGEAL FULLY COVERED STENT WAS IMPLANTED TO REINFORCE THE CLOSURE OF THE FISTULA. ON AN UNKNOWN DATE, POST-STENT PLACEMENT OF THE SECOND WALLFLEX ESOPHAGEAL STENT, THE PATIENT PASSED AWAY. THE RELATIONSHIP BETWEEN THE WALLFLEX ESOPHAGEAL STENTS AND THE PATIENT'S DEATH IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18447569 ↗
• MalfunctionMay 12, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2023, THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS TO BE IMPLANTED TO THE ESOPHAGUS TO TREAT A STRICTURE DURING AN ESOPHAGEAL METAL STENTING PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE DEVICE WAS INSERTED; HOWEVER, UNDER ENDOSCOPIC VIEW, IT WAS NOTED THAT THE TIP WAS DETACHED. THE TIP REMAINED INSIDE THE PATIENT 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 16919149 ↗
• MalfunctionJan 3, 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)(4) 2022, THAT A WALLLFEX PARTIALLY COVERED ESOPHAGEAL STENT WAS IMPLANTED TO TREAT A MALIGNANT STRICTURE POST ESOPHAGECTOMY DURING A GASTROSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(4) 2022. DURING THE PROCEDURE, SEVERAL ATTEMPTS WERE MADE TO PASS THE STENT DELIVERY SYSTEM THROUGH THE PYLORUS. THE WALLFLEX ESOPHAGEAL STENT WAS THEN SUCCESSFULLY DEPLOYED. UNDER FLUOROSCOPY. THE TIP OF THE DELIVERY SYSTEM APPEARED TO BE DISLODGED FROM THE CATHETER AND WAS PLACED IN THE DUODENUM. AFTER REMOVAL OF THE DELIVERY SYSTEM, IT WAS CONFIRMED THAT THE TIP WAS DETACHED AND REMAINED INSIDE THE PATIENT. THE PHYSICIAN DECIDED TO LEAVE THE TIP INSIDE THE PATIENT AND ALLOW THE TIP TO PASS NATURALLY. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16090132 ↗
• InjuryAug 24, 2022Break; Difficult to Remove; Use of Device Problem; Obstruction of Flow; Break; Difficult to Remove; Use of Device Problem; Obstruction of Flow

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS IMPLANTED TO TREAT A BENIGN STRICTURE IN THE ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. THE PATIENT'S ANATOMY WAS NOT TORTUOUS. ON (B)(6) 2022, DURING A SCHEDULED STENT REMOVAL PROCEDURE, TISSUE INGROWTH WITHIN THE WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS NOTED. DURING THE PROCEDURE, THE GREEN STENT RETENTION SUTURE BROKE AND THE WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS UNABLE TO BE REMOVED. THE WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT REMAINED IMPLANTED AND THE PROCEDURE WAS RESCHEDULED. ON (B)(6) 2022, GASTROSCOPY PROCEDURE WAS PERFORMED AND A BOSTON SCIENTIFIC FULLY COVERED ESOPHAGEAL STENT WAS IMPLANTED STENT-IN-STENT TO PROVIDE PRESSURE NECROSIS TO THE TISSUE INGROWTH. ON (B)(6) 2022, BOTH PARTIALLY AND FULLY COVERED ESOPHAGEAL STENTS WERE REMOVED FROM THE PATIENT USING A GRASPING FORCEPS. 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: IT WAS REPORTED THAT THE WALLFLEX ESOPHAGEAL PARTIALLY COVERED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15288151 ↗
• InjuryApr 21, 2022Material Deformation; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED 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 TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS FULLY DEPLOYED AND GOT BENT INTO THE TUMOR. IN THE PHYSICIAN'S ASSESSMENT THE PATIENT'S TORTUOUS ANATOMY CONTRIBUTED TO THE DEFORMED STENT INSIDE THE TUMOR. THE STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS; HOWEVER, AS THE STENT WAS REMOVED IT GRAZED THE ESOPHAGUS WHICH RESULTED IN BLEEDING. THE PROCEDURE WAS COMPLETED WITH ANOTHER WALLFLEX ESOPHAGEAL STENT, WHICH WAS ALSO USED AS TAMPONADE FOR THE BLEED, AND NO OTHER INTERVENTION WAS PERFORMED TO ADDRESS THE BLEEDING. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14174920 ↗
• InjurySep 13, 2019Break; Migration; Break; Migration

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENT WAS IMPLANTED IN THE CARDIA OF THE STOMACH DURING A GASTROSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED IN 2018. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2019, THE PATIENT PRESENTED WITH DYSPHAGIA. THE PHYSICIAN CHECKED THE STENT PLACEMENT USING A SCOPE AND CONFIRMED THAT THE STENT WAS BROKEN INTO TWO SEPARATE PIECES. THE PROXIMAL END OF THE STENT HAD MIGRATED INTO THE STOMACH AND THE OTHER PORTION OF THE STENT REMAINED IN THE ESOPHAGUS. THE STENT WAS REMOVED WITH FORCEPS. REPORTEDLY, THE STRICTURE AND DYSPHAGIA HAD NOT RESOLVED AND ANOTHER STENT WILL BE IMPLANTED AT A FUTURE DATE. THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE GOOD.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 9035569 ↗
• InjuryAug 24, 2017Positioning Problem; Positioning Problem

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT# 3005099803-2017-02591 AND 3005099803-2017-02593 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT TWO WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENTS WERE IMPLANTED TO TREAT A LEAK JUST ABOVE A MALIGNANT STRICTURE. REPORTEDLY, THE PATIENT¿S ANATOMY WAS TORTUOUS AND WAS SURGICALLY-ALTERED. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2017, THE FIRST STENT (THE SUBJECT OF MFR. REPORT# 3005099803-2017-02591) WAS SUCCESSFULLY IMPLANTED BUT WAS SCHEDULED TO BE REPLACED AS IT WAS NOT THE PHYSICIAN¿S STENT OF CHOICE. ON (B)(6) 2017, DURING THE SCHEDULED STENT EXCHANGE PROCEDURE, THE PHYSICIAN COULD NOT REMOVE THE FIRST IMPLANTED STENT. THE PHYSICIAN DECIDED TO LEAVE THE FIRST STENT IMPLANTED. THE SECOND STENT (THE SUBJECT OF THIS REPORT) WAS DEPLOYED WITHIN THE FIRST STENT BUT WAS IMPLANTED HANGING INTO THE STOMACH. THE SECOND STENT WAS REPOSITIONED USING FORCEPS TO OVERLAP THE LEAKAGE AREA AND BLEEDING IN THE STOMACH WAS NOTED. NO INTERVENTION WAS DONE TO TREAT THE BLEED AND IT RESOLVED ON ITS OWN. THE PHYSICIAN LEFT BOT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6816317 ↗