OviTex® 1S F10246-1620PRecalls & reported problems
Aroa Biosurgery Limited · The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. OviTex Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device remodels and helps regenerate tissue while reinforcing the repair and providing structural support. Reinforced tissue matrices enhance performance while maintaining compatibility with the body. The OviTex Reinforced Tissue Matrix Device is used for hernia repair and abdominal wall reconstruction. · Class 2 · Implant
All models of OviTex 1S (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 09421904065116), received between Sep 27, 2021 and Jan 5, 2026 — classified as 4 injuries.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- Hernia2
- Seroma2
- Wound Dehiscence2
- Post Operative Wound Infection1
- Unspecified Infection1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2024. THE PRIMARY REPAIR INCLUDED INCARCERATED BOWEL WHICH WAS REDUCED AND PRIMARY CLOSURE OBTAINED. THE PATIENT PRESENTED WITH A BULGE IN THE SUPRAUMBILICAL AREA IN (B)(6) 2025 WITH SUSPECTED HERNIA RECURRENCE. THE HERNIA WAS REDUCED AND REPAIRED ON (B)(6) 2025 VIA A ROBOTIC TAPP HERNIA REPAIR PROCEDURE.
Patient problems: Hernia
MAUDE report 23954720 ↗InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2024. THE PRIMARY REPAIR INCLUDED INCARCERATED BOWEL WHICH WAS REDUCED AND PRIMARY CLOSURE OBTAINED. THE PATIENT PRESENTED WITH A BULGE IN THE SUPRAUMBILICAL AREA IN (B)(6) 2025 WITH SUSPECTED HERNIA RECURRENCE. THE HERNIA WAS REDUCED AND REPAIRED ON (B)(6) 2025 VIA A ROBOTIC TAPP HERNIA REPAIR PROCEDURE.
Patient problems: Hernia
MAUDE report 23921942 ↗InjuryOct 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT VENTRAL HERNIA REPAIR WITH OVITEX 1SP ON (B)(6) 2018. THE PATIENT DEVELOPED PERSISTENT INFECTION AND WOUND DEHISCENCE WITH PRESENCE OF SEROMA. SURGICAL INTERVENTION WAS CONDUCTED ON (B)(6) 2020 INCLUDING DEBRIDEMENT OF ABDOMINAL WALL SKIN/SINUS TRACT AND REMOVAL OF EMBEDDED REPAIR MATERIAL.
Patient problems: Seroma; Unspecified Infection; Wound Dehiscence
MAUDE report 12595175 ↗InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT VENTRAL HERNIA REPAIR WITH OVITEX 1SP ON (B)(6) 2018. THE PATIENT DEVELOPED PERSISTENT INFECTION AND WOUND DEHISCENCE WITH PRESENCE OF SEROMA. SURGICAL INTERVENTION WAS CONDUCTED ON (B)(6) 2020 INCLUDING DEBRIDEMENT OF ABDOMINAL WALL SKIN/SINUS TRACT AND REMOVAL OF EMBEDDED REPAIR MATERIAL.
Patient problems: Post Operative Wound Infection; Seroma; Wound Dehiscence
MAUDE report 12533761 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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