Transorb TSB1510Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521809703), received between Oct 21, 2025 and Oct 21, 2025 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE CLINICAL STUDY, POST-OPERATIVELY, THE PATIENT PRESENTED AFTER ONE YEAR FOR A SCHEDULED FOLLOW UP AND REPORTED THAT THEY HAD A RECENT COUGHING ATTACK AND FELT A WORM-LIKE PROTRUSION IN THEIR UPPER ABDOMEN. THE PATIENT FELT THE SENSATION WHEN ABDOMINAL MUSCLES WERE CONTRACTING WITH COUGHING, LAUGHING, OR SNEEZING. A DIAGNOSTIC ULTRASOUND PERFORMED ON (B)(6) 2025 SHOWED FAT CONTAINING SUPRAUMBILICAL VENTRAL HERNIA. THE PATIENT HAD A VENTRAL HERNIA RECURRENCE. THE SPONSOR ASSESSED THAT THE ADVERSE EVENT WAS NOT RELATED TO AN OUTSIDE STANDARD OF CARE CIP PROCEDURE AND THE STUDY MESH, BUT HAS CAUSAL RELATIONSHIP TO THE STUDY PROCEDURE. ON THE OTHER HAND, THE INVESTIGATOR ASSESSED THAT THE ADVERSE EVENT WAS NOT RELATED TO AN OUTSIDE STANDARD OF CARE CIP PROCEDURE, BUT HAS CAUSAL RELATIONSHIP TO THE STUDY PROCEDURE AND THE STUDY MESH.

  Patient problems: Hernia

  MAUDE report 23346884 ↗