Transorb TSB4030Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521809734), received between Mar 13, 2025 and Jul 2, 2025 — 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.

• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PRIOR MESH INFECTION UNDERWENT A PANNICULECTOMY PROCEDURE, DURING WHICH THE MESH WAS IMPLANTED. POSTOPERATIVELY, A NON-SYMPTOMATIC SEROMA DEVELOPED, ATTRIBUTED TO THE PANNICULECTOMY, AND REQUIRED SURGICAL TREATMENT. THE SEROMA WAS NOT CONSIDERED RELATED TO THE STUDY MESH OR OUTSIDE STANDARD OF CARE PROCEDURES BY THE INVESTIGATOR. THE PATIENT WAS REPORTED TO BE RECOVERING OR RESOLVING.

  Patient problems: Seroma

  MAUDE report 22382881 ↗
• MalfunctionMar 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WITH OBESITY, DIABETES MELLITUS, AND HYPERTENSION UNDERWENT LAPAROSCOPIC SURGERY FOR A VENTRAL HERNIA WITH INTRAPERITONEAL MESH PLACEMENT USING THE DEVICE. FOLLOWING THE PROCEDURE, A HEMATOMA DEVELOPED IN THE RETROUMBILICAL SUBCUTANEOUS SOFT TISSUE. AN X-RAY CONDUCTED ON (B)(6) 2025, CONFIRMED THE PRESENCE OF THE HEMATOMA, WHICH WAS DEEMED CLINICALLY SIGNIFICANT.

  Patient problems: Hematoma; Unintended Radiation Exposure

  MAUDE report 21709526 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN OPEN VENTRAL HERNIA REPAIR USING AN ABSORBABLE MESH, A POST-OPERATIVE COMPLICATION OCCURRED, LEADING TO THE EXPLANATION OF THE MESH. THE PROCEDURE INVOLVED A TRANSVERSUS ABDOMINIS RELEASE IN THE MIDDLE ABDOMEN. THE PATIENT RETURNED TO THE EMERGENCY ROOM SEVERAL DAYS AFTER THE INITIAL PROCEDURE. THE MESH WAS REMOVED DUE TO THE COMPLICATION.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21602261 ↗