WallFlex™ Esophageal M00516920Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729765264), received between Mar 19, 2018 and May 23, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (1 report).

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-3283-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2023Use of Device Problem; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Use of Device Problem; Activation, Positioning or Separation Problem; 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 TREAT AN ESOPHAGEAL STENOSIS DURING AN ESOPHAGEAL STENTING PROCEDURE PERFORMED ON APRIL 29, 2023. DURING THE PROCEDURE, THE TIP DETACHED WHEN THE DEVICE WAS ADVANCED THROUGH THE ESOPHAGUS. THE DEVICE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS NOT COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. A PHOTO OF THE DEVICE PROVIDED BY THE COMPLAINANT SHOWS THAT THE STENT WAS PARTIALLY DEPLOYED, AND THE TIP WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16984404 ↗
• InjuryApr 5, 2022Difficult to Remove; Positioning Problem; Difficult to Remove; Positioning Problem

  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 STENOSIS DURING AN ESOPHAGEAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2022. THE PATIENT'S ANATOMY WAS TIGHT. DURING THE PROCEDURE, THE STENT WAS DEPLOYED IN THE STOMACH. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT, HOWEVER, THE STRICTURE WAS TOO TIGHT AND THE STENT COULD NOT BE REMOVED. THE STENT REMAINS IMPLANTED AND ANOTHER WALLFLEX ESOPHAGEAL STENT WAS IMPLANTED 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 STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14015644 ↗
• MalfunctionJun 11, 2020Positioning Failure; Failure to Advance; Material Integrity Problem; Positioning Failure; Failure to Advance; Material Integrity Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2020-02156. FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2020 THAT TWO WALLFLEX ESOPHAGEAL PARTIALLY COVERED STENTS WERE TO BE USED TO TREAT A 7CM EXTRINSIC STRICTURE IN THE LOWER ESOPHAGEAL SPHINCTER DURING A STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS DILATED PRIOR TO STENT PLACEMENT. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIRST WALLFLEX ESOPHAGEAL STENT (THE SUBJECT OF MFR. REPORT # 3005099803-2020-02156) HAD DIFFICULTY IN CROSSING THE ANATOMY AND WAS UNABLE TO BE DEPLOYED. UPON REMOVAL OF THE STENT DELIVERY SYSTEM, IT WAS NOTICED THAT THE WHITE OLIVE TIP WAS BENT. A SECOND WALLFLEX ESOPHAGEAL STENT (THE SUBJECT OF THIS REPORT) WAS USED, HOWEVER, THE SAME ISSUES OCCURED AND THE WHITE OLIVE TIP WAS AGAIN BENT. REPORTEDLY, THE PHYSICIAN CALLED OFF ANY FURTHER TREATMENT. 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 10143414 ↗
• InjuryMar 19, 2018Activation Failure; Activation Failure

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 26, 2018 THAT A WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT WAS IMPLANTED TO TREAT A STRICTURE IN THE ESOPHAGUS DURING A GASTROINTESTINAL ENDOSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT'S ANATOMY WAS TORTUOUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. THE STENT WAS SUCCESSFULLY DEPLOYED DURING THE PROCEDURE ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, 48 HOURS AFTER THE STENT PLACEMENT, A BARIUM SWALLOW EXAM WAS PERFORMED TO VIEW THE STENT FLUOROSCOPICALLY. IT WAS NOTED THAT THE STENT WAS EXPANDED DISTALLY BUT WAS NOT EXPANDED PROXIMAL TO THE MOUTH. ANOTHER WALLFLEX ESOPHAGEAL STENT WAS IMPLANTED WITHIN THE FIRST STENT TO OPEN UP THE PROXIMAL FLANGE AND THIS COMPLETED 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7350181 ↗