Transorb TSB3030Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521809727), received between Jan 28, 2025 and Jul 20, 2026 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, FOLLOWING A POST-PROCEDURE PERIOD INVOLVING IMPLANTATION OF THE MESH, THE PATIENT EXPERIENCED A RECURRENT INCISIONAL HERNIA WITH ABDOMINAL PAIN. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT, WHERE COMPUTED TOMOGRAPHY IMAGING DEMONSTRATED A BOWEL- AND FAT-CONTAINING UMBILICAL HERNIA WITHOUT OBSTRUCTION. THE HERNIA WAS REDUCED IN THE EMERGENCY DEPARTMENT WITH SYMPTOM RELIEF. THE EVENT WAS CONSIDERED SERIOUS, WITHOUT HOSPITALIZATION. THE PATIENT SUBSEQUENTLY HAD AN UNSCHEDULED FOLLOW-UP VISIT THAT RESULTED IN A RECOMMENDATION FOR HERNIA REPAIR WITH RECONSTRUCTION. THE HERNIA WAS TREATED WITH A HERNIA REDUCTION. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE STUDY MESH AND NOT RELATED TO A STUDY PROCEDURE OR AN OUTSIDE STANDARD-OF-CARE PROCEDURE.

  Patient problems: Abdominal Pain; Hernia; Unintended Radiation Exposure

  MAUDE report 25874742 ↗
• InjuryDec 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING CLINICAL, THE PATIENT HAD A CHRONIC PURULENT WOUND. THE WOUND WAS FIBRINOUS, PURULENT, AND OOZING. LABORATORY TESTS SHOWED A CRP LEVEL OF 13 MG/L. A COMPUTED TOMOGRAPHY SCAN REVEALED A SUBCUTANEOUS INFILTRATION WITHOUT COLLECTION IN CONTACT WITH THE PROSTHESIS. GIVEN THE POOR PROGRESS OF THE WOUND, THE PATIENT WAS TAKEN TO THE OPERATING ROOM. DEBRIDEMENT AND APPLICATION OF A VAC-TYPE DRESSING. THE MESH IS STILL IMPLANTED. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2025, UNTIL (B)(6) 2025. THE ADVERSE EVENT WAS RELATED TO THE STUDY PROCEDURE AND NOT RELATED TO THE MESH.

  Patient problems: Inflammation; Insufficient Information; Purulent Discharge; Tissue Breakdown; Unintended Radiation Exposure

  MAUDE report 23892319 ↗
• InjurySep 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING THE IMPLANTATION OF THE MESH, THERE WAS A SUBCUTANEOUS SEROMA, SWELLING AT THE SITE OF THE FORMER HERNIA WITHOUT PAIN, INFLAMMATION WITH PUS IN THE PELVIC AREA, A HARD BUT PAINLESS LEFT ABDOMEN, AND A SCAR WITH STAPLES IN THE PERIUMBILICAL/PELVIC AREA. DIAGNOSTIC TESTS INCLUDED PHYSICAL EXAMINATION, TAP SCANNER IMAGING, AND LIQUID PUNCTURE FOR THE SEROMA. INTERVENTIONS PERFORMED WERE LIQUID PUNCTURE AND THE INTRODUCTION OR RESTART OF ANTICOAGULANTS AFTER SURGERY. A LIQUID PUNCTURE WAS PERFORMED FOR THE SEROMA, AND ANTICOAGULANTS WERE INTRODUCED OR RESTARTED AFTER SURGERY ON (B)(6) 2025. THE ADVERSE EVENT WAS RESOLVED. BOTH THE INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX PROCEDURE AND THE STUDY MESH.

  Patient problems: Hematoma; Inflammation; Scar Tissue; Seroma; Swelling/ Edema; Unintended Radiation Exposure

  MAUDE report 23080609 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN OPEN VENTRAL HERNIA REPAIR PROCEDURE, A SMALL CENTIMETRIC WOUND DEHISCENCE OCCURRED IN THE MEDIAN PART OF THE LAPAROTOMY OPPOSITE THE JUNCTION BETWEEN THE TRANSVERSE AND MEDIAN INCISIONS. THE PATIENT UNDERWENT MULTIPLE VENTRAL HERNIA SURGERIES, INCLUDING INTRAPERITONEAL AND ONLAY MESH PLACEMENTS. WOUND CARE WITH MECHAGE WAS PERFORMED AS AN INTERVENTION.

  Patient problems: Wound Dehiscence

  MAUDE report 22646465 ↗
• MalfunctionJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST-OPERATIVELY ON AN OPEN REPAIR OF VENTRAL HERNIA WITH STUDY MESH PLACEMENT, THE PATIENT EXPERIENCED A RECURRENCE OF HERNIA, SPECIFICALLY A RECURRENCE OF SUPRAPUBIC EVENTRATION WITH A NECK MEASURING APPROXIMATELY 2-3 CM, WHICH WAS DESCRIBED AS EASILY REDUCIBLE, UNCOMPLICATED, AND ASYMPTOMATIC. DIAGNOSTIC TESTS WERE PERFORMED.

  Patient problems: Hernia

  MAUDE report 22216227 ↗
• MalfunctionApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FOLLOWING AN OPEN VENTRAL HERNIA REPAIR SURGERY, THE PATIENT EXPERIENCED NAUSEA, ILEUS, AND VOMITING. THE PROCEDURE INVOLVED THE USE OF GRIPPING RESORB MESH 20X30CM. THE ADVERSE EVENT WAS ASSESSED AS POSSIBLY RELATED TO THE INDEX PROCEDURE BUT NOT RELATED TO THE STUDY MESH. THE PATIENT RECOVERED AND THE ADVERSE EVENT WAS RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Nausea; Pain; Vomiting

  MAUDE report 21884750 ↗
• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE CLINICAL STUDY, TWO DAYS POST-OPERATIVELY, THE PATIENT WOULD NOT RESUME TRANSIT WITH THE NEED TO MAINTAIN A NASOGASTRIC TUBE. FIVE DAYS LATER, X-RAY WAS PERFORMED AND IT WAS NOTED THAT THE PATIENT HAD SMALL INTESTINAL OBSTRUCTION. TO RESOLVE THE ISSUE. THE PATIENT UNDERWENT EXPLORATORY LAPAROSCOPY TO EXPLANT THE STUDY MESH AND REPLACE IT WITH A NEW ONE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Necrosis; Obstruction/Occlusion; Unintended Radiation Exposure

  MAUDE report 21249470 ↗