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OviTex® 1S F10246-1020PRecalls & 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
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09421904065109), received between Mar 28, 2019 and Mar 28, 2019 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Insufficient Device Problem Information1

Patient problems

  • Abdominal Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    ON (B)(6) 2018, A PATIENT WITH A HISTORY OF DIVERTICULOSIS AND A RIGHT HEMI-COLECTOMY UNDERWENT A ROBOTIC LAPAROSCOPIC INCISIONAL REPAIR OF AN INCISIONAL HERNIA IN THE MIDLINE. PRIMARY CLOSURE WAS OBTAINED AND REINFORCED WITH INTRAPERITONEAL PLACEMENT OF OVITEX 1S PERMANENT 16X20CM. THE MESH WAS CUT INTO TWO EQUAL PIECES AND SEWN TOGETHER (APPROXIMATELY 10X30CM). IN LATE (B)(6) 2019, THE PATIENT PRESENTED WITH SWELLING AND PAIN OF THE ANTERIOR ABDOMINAL WALL. A CT REVEALED FREE AIR IN THE SUBCUTANEOUS TISSUE. THE PROXIMAL AND DISTAL ENDS OF THE WOUND WERE OPENED AND COPIOUS AMOUNT OF FECAL MATTER WAS EVACUATED, AND WITH IT A PORTION OF THE POLYMER REINFORCEMENT OF THE MESH. UPON FURTHER INSPECTION THE SURGEON FOUND AN ENTERIC FISTULA THAT COMMUNICATED WITH THE SUBCUTANEOUS SPACE. THE SUBCUTANEOUS SPACE WAS LAVAGED AND INSPECTED. EXCEPT FOR THE FISTULA, THE FASCIA AND HERNIA REPAIR APPEARED INTACT. ANTIBIOTICS WERE STARTED AND SUBSEQUENTLY THE FISTULA WAS FIRST LIGATED AND THEN REMOVED.

    Patient problems: Abdominal Pain

    MAUDE report 8459986 ↗

Other Mesh, Surgical, Polymeric devices

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Sources and updates

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