Ultraflex™ Esophageal NG M00513830Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729716204), received between Jul 13, 2021 and Feb 25, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 25, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THIS ULTRAFLEX ESOPHAGEAL NG PROXIMAL RELEASE STENT WAS RETURNED TO BOSTON SCIENTIFIC CORPORATION WITHOUT ANY REPORT OF PERFORMANCE ISSUES OR ADVERSE PATIENT EFFECTS. THE RETURNED DEVICE WAS ANALYZED AND THE STENT WAS PARTIALLY DEPLOYED AND THE SHAFT WAS SLIGHTLY BENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION FINDING OF STENT PARTIALLY DEPLOYED. NOTE: BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13599261 ↗
• MalfunctionJul 13, 2021Positioning Failure; Activation, Positioning or Separation Problem; Appropriate Device Problem Term/Code Not Available; Positioning Failure; Activation, Positioning or Separation Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT AN ULTRAFLEX ESOPHAGEAL NG UNCOVERED PROXIMAL RELEASE STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS DURING A STENT PLACEMENT PROCEDURE FOR POST-RADIATION ESOPHAGUS SQUAMOUS CELL CARCINOMA PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED. THE PROCEDURE WAS NOT COMPLETED AS ANOTHER STENT OF THE SAME SIZE WAS UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON JULY 13, 2021. THE ULTRAFLEX ESOPHAGEAL NG UNCOVERED PROXIMAL RELEASE STENT WAS PARTIALLY COVERED BY THE BLACK STENT DEPLOYMENT SUTURE WHEN IT WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12159337 ↗