OviTex® 1S F10246-1012PRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 09421904065093), received between Jun 12, 2020 and Aug 12, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Contamination with Body Fluid” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A POST-OPERATIVE INFECTION AND BOWEL OBSTRUCTION. THE LATTER LED TO BOWEL OBSTRUCTIVE SYMPTOMS AND RE-OPERATION WHERE ADHESIONS WERE NOTED. THE DEVICE WAS REMOVED AFTER ADHESIONS WERE FREED. THERE WAS NO REPORTED PERMANENT DAMAGE.

  Patient problems: Adhesion(s); Bacterial Infection; Obstruction/Occlusion

  MAUDE report 19968958 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A POST-OPERATIVE INFECTION AND BOWEL OBSTRUCTION. THE LATTER LED TO BOWEL OBSTRUCTIVE SYMPTOMS AND RE-OPERATION WHERE ADHESIONS WERE NOTED. THE DEVICE WAS REMOVED AFTER ADHESIONS WERE FREED. THERE WAS NO REPORTED PERMANENT DAMAGE.

  Patient problems: Adhesion(s); Bacterial Infection; Obstruction/Occlusion

  MAUDE report 19951531 ↗
• InjuryJan 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A POST-OPERATIVE SEROMA FOLLOWED BY HERNIA RECURRENCE AFTER PARASTOMAL HERNIA REPAIR USING OVITEX 1S PERMANENT.

  Patient problems: Hernia

  MAUDE report 16273637 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A POST-OPERATIVE SEROMA FOLLOWED BY HERNIA RECURRENCE AFTER PARASTOMAL HERNIA REPAIR USING OVITEX 1S PERMANENT.

  Patient problems: Hernia

  MAUDE report 16246289 ↗
• InjuryJan 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WITH PERFORATED DIVERTICULITIS POST COLOSTOMY UNDERWENT ROBOTIC LYSIS OF ADHESIONS, PARTIAL COLECTOMY AND LOW COLORECTAL ANASTOMOSIS TO TAKE DOWN THE COLOSTOMY. THE SURGEON THEN MADE AN EXTERIOR INCISION AT SITE OF THE COLOSTOMY TO CLOSE THE DEFECT. THE SURGEON PLACED OVITEX IN AN ONLAY FASHION OVER THE CLOSED DEFECT. DURING POST-SURGICAL FOLLOW UP THE PATIENT EXPERIENCED AN ABSCESS AND PERSISTENT SEROMA WHICH HAS BEEN DRAINED MULTIPLE TIMES UNDER INTERVENTIONAL RADIOLOGY.

  Patient problems: Abscess; Seroma

  MAUDE report 16143272 ↗
• InjuryDec 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WITH PERFORATED DIVERTICULITIS POST COLOSTOMY UNDERWENT ROBOTIC LYSIS OF ADHESIONS, PARTIAL COLECTOMY AND LOW COLORECTAL ANASTOMOSIS TO TAKE DOWN THE COLOSTOMY. THE SURGEON THEN MADE AN EXTERIOR INCISION AT SITE OF THE COLOSTOMY TO CLOSE THE DEFECT. THE SURGEON PLACED OVITEX IN AN ONLAY FASHION OVER THE CLOSED DEFECT. DURING POST-SURGICAL FOLLOW UP THE PATIENT EXPERIENCED AN ABSCESS AND PERSISTENT SEROMA WHICH HAS BEEN DRAINED MULTIPLE TIMES UNDER INTERVENTIONAL RADIOLOGY.

  Patient problems: Abscess; Seroma

  MAUDE report 16055550 ↗
• InjuryJun 12, 2020Device Contamination with Body Fluid; Device Contamination with Body Fluid

  OVITEX 1SP WAS USED TO ROBOTICALLY REPAIR AN UMBILICAL HERNIA CONTAINING TWO BOWEL LOOPS, ONE OF WHICH WAS INCARCERATED CAUSING BOWEL OBSTRUCTION AND BOWEL ISCHEMIA. THE DEVICE WAS INTRODUCED THROUGH THE INCISION SITE. APPROXIMATELY ONE WEEK LATER, THE WOUND BECAME RED AND AN ABSCESS FORMED BETWEEN THE OVITEX AND THE ABDOMINAL WALL. THE SURGEON STARTED ANTIBIOTICS, INCISED THE ABSCESS AND REMOVED THE DEVICE. CULTURES WERE POSITIVE FOR E. COLI AND STREPTOCOCCUS.

  Patient problems: Abscess

  MAUDE report 10148826 ↗