Ultraflex™ Esophageal NG M00513700Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729716129), received between Oct 11, 2017 and Feb 1, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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 18, 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 1, 2023Positioning Failure; Activation, Positioning or Separation Problem; Material Deformation; Positioning Failure; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX ESOPHAGEAL NG DISTAL RELEASED UNCOVERED STENT WAS TO BE IMPLANTED IN THE ESOPHAGUS DURING AN ESOPHAGEAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE BLACK DEPLOYMENT SUTURE OF THE ULTRAFLEX ESOPHAGEAL STENT WAS FOUND TO BE ENTANGLED AND THE ULTRAFLEX ESOPHAGEAL STENT WAS UNABLE TO BE DEPLOYED, THE ULTRAFLEX ESOPHAGEAL STENT WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX ESOPHAGEAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: THIS COMPLAINT HAS BEEN DEEMED AN MDR REPORTABLE EVENT BASED ON THE PRODUCT INVESTIGATION WHICH REVEALED THAT THE STENT WAS PARTIALLY DEPLOYED. PLEASE SEE BLOCK H10 FOR FULL INVESTIGATION DETAIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16281012 ↗
• InjuryOct 11, 2017Premature Activation; Premature Activation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2017 THAT AN ULTRALFLEX ESOPHAGEAL NG UNCOVERED DISTAL RELEASE STENT WAS TO BE USED TO TREAT A MALIGNANT STRICTURE IN THE ESOPHAGUS DURING A GASTROSCOPY WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2017. REPORTEDLY, THE PATIENT'S ANATOMY WAS NOT TORTUOUS. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN APPLIED "GREAT FORCE" TO DEPLOY THE STENT, WHICH CAUSED THE STENT TO BE DEPLOYED PREMATURELY IN THE PATIENT'S STOMACH. THE PHYSICIAN USED FORCEPS TO REPOSITION THE STENT AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. 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 6942168 ↗