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OviTex® 2S F10248-1020PRecalls & 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

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 09421904065178), received between Oct 11, 2019 and Aug 25, 2022 — classified as 3 injuries.

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

  • Adverse Event Without Identified Device or Use Problem2
  • Insufficient Device Problem Information1

Patient problems

  • Obstruction/Occlusion2
  • No Information1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A SMALL BOWEL OBSTRUCTION WAS REPORTED AFTER THE USE OF OVITEX 2S PERMANENT IN OPEN IPOM SUGARBAKER PARASTOMAL HERNIA REPAIR. THIS REQUIRED REOPERATION AT WHICH TIME THERE WERE NOTED LOOPS OF SMALL BOWEL ATTACHED TO THE DEVICE AND TO THE COLON ON THE OPPOSITE SIDE. THE SURGEON TOOK DOWN ADHESIONS AND CORRECTED TEARS AS NECESSARY.

    Patient problems: Obstruction/Occlusion

    MAUDE report 15299217 ↗
  • InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    A SMALL BOWEL OBSTRUCTION WAS REPORTED AFTER THE USE OF OVITEX 2S PERMANENT IN OPEN IPOM SUGARBAKER PARASTOMAL HERNIA REPAIR. THIS REQUIRED REOPERATION AT WHICH TIME THERE WERE NOTED LOOPS OF SMALL BOWEL ATTACHED TO THE DEVICE AND TO THE COLON ON THE OPPOSITE SIDE. THE SURGEON TOOK DOWN ADHESIONS AND CORRECTED TEARS AS NECESSARY.

    Patient problems: Obstruction/Occlusion

    MAUDE report 15266190 ↗
  • InjuryOct 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    A PATIENT HAD A HERNIA REPAIRED WITH OVITEX 2SP ON (B)(6) 2019. TISSUE APPROXIMATION COULD NOT BE OBTAINED, THE SKIN WAS CLOSED, AND A WOUND VACUUM WAS PLACED. THE PATIENT WAS RE-OPERATED ON FOR AN UNKNOWN REASON AND A PORTION OF THE BIOLOGIC COMPONENT APPEARED NO LONGER PRESENT. THE REMAINING OVITEX WAS EXPLANTED.

    Patient problems: No Information

    MAUDE report 9181894 ↗

Other Mesh, Surgical, Polymeric devices

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Sources and updates

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