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OviTex® Core F10254-2020GRecalls & 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 09421904065277), received between Dec 21, 2018 and Dec 14, 2021 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

21 other recalls cover devices cleared under the same FDA submission (K153633); they may or may not involve this specific model.

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

  • Seroma2
  • No Code Available1

Recent adverse event reports

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

  • InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A PERSISTENT SEROMA AFTER IMPLANTATION OF OVITEX R TO REINFORCE A DIEP FLAP DONOR SITE ON (B)(6) 2021. THE IMPLANTED MATERIAL WAS PARTIALLY REMOVED ON (B)(6) 2021.

    Patient problems: Seroma

    MAUDE report 13003967 ↗
  • InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A PERSISTENT SEROMA AFTER IMPLANTATION OF OVITEX R TO REINFORCE A DIEP FLAP DONOR SITE ON (B)(6) 2021. THE IMPLANTED MATERIAL WAS PARTIALLY REMOVED ON (B)(6) 2021.

    Patient problems: Seroma

    MAUDE report 13001805 ↗
  • InjuryDec 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

    A PATIENT REPORTED THAT SHE UNDERWENT BILATERAL BREAST RECONSTRUCTION IN WHICH OVITEX WAS UTILIZED. SHE REPORTED THAT SOMETIME AFTER THE PROCEDURE THAT SHE BELIEVED THAT THE MESH DID NOT STAY IN PLACE IN ONE BREAST AND THE IMPLANT "ALMOST LITERALLY FELL OUT". THE BREAST IMPLANT ENDED UP BEING SURGICALLY REMOVED.

    Patient problems: No Code Available

    MAUDE report 8190303 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K153633. One submission often covers many models, so check the product and lot details in each record.

  • Z-0430-2019 · Apr 6, 2018 · Terminated
    OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G
  • Z-0435-2019 · Apr 6, 2018 · Terminated
    OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
  • Z-0432-2019 · Apr 6, 2018 · Terminated
    OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G
  • Z-0429-2019 · Apr 6, 2018 · Terminated
    OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
  • Z-0422-2019 · Apr 6, 2018 · Terminated
    OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G
  • Z-0419-2019 · Apr 6, 2018 · Terminated
    OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G
  • Z-0434-2019 · Apr 6, 2018 · Terminated
    OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822G
  • Z-0426-2019 · Apr 6, 2018 · Terminated
    OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822G
  • Z-0418-2019 · Apr 6, 2018 · Terminated
    OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G
  • Z-0421-2019 · Apr 6, 2018 · Terminated
    OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G
  • Z-0417-2019 · Apr 6, 2018 · Terminated
    OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G
  • Z-0427-2019 · Apr 6, 2018 · Terminated
    OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G
  • Z-0416-2019 · Apr 6, 2018 · Terminated
    OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G
  • Z-0423-2019 · Apr 6, 2018 · Terminated
    OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G
  • Z-0420-2019 · Apr 6, 2018 · Terminated
    OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G

…and 6 more.

Other Mesh, Surgical devices

All Mesh, Surgical devices →

Sources and updates

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