Edge SDSEWCTE-FTRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521581418), received between Feb 17, 2023 and Feb 17, 2023 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE ARC POINT NEEDLE HAD PUNCTURED THE FISSURE LEADING TO PNEUMOTHORAX ON A NON-MEDTRONIC PRODUCT. RIGHT CHEST DRAIN INSERTION AND CHEMICAL PLEURODESIS WAS PERFORMED AND THE PROCEDURE CONTINUED. VENTOLIN BY ORAL INHALATION AND HYDROCORTISONE BY INTRAVENOUS INJECTION WAS GIVEN. THE HOSPITALIZATION OF THE PATIENT WAS PROLONGED. THE ADVERSE EVENT HAS PROBABLE RELATION TO THE DEVICES AND STUDY PROCEDURE.

  Patient problems: Pneumothorax

  MAUDE report 16396210 ↗