Transorb TSB2020Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521809710), received between Aug 12, 2025 and Sep 18, 2026 — classified as 2 injuries, 1 malfunction.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Seroma

  MAUDE report 50829159 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Fever; Purulent Discharge; Unintended Radiation Exposure; Unspecified Infection

  MAUDE report 50763376 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH CURRENT OBESITY AND A HISTORY OF OPEN COLORECTAL SURGERIES UNDERWENT AN INCISIONAL EPIGASTRIC, UMBILICAL, INFRAUMBILICAL EASILY REDUCIBLE HERNIA INVOLVING THE MESH. FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED SEVERE ABDOMINAL PAIN. ON (B)(6) 2025, AN X-RAY WAS PERFORMED TO DIAGNOSE SEROMA. THE PAIN RESOLVED. BOTH THE INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX PROCEDURE AND THE STUDY MESH.

  Patient problems: Abdominal Pain; Unintended Radiation Exposure

  MAUDE report 22782598 ↗