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OviTex® 1S F10256-2020GRecalls & 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

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 09421904065345), received between Jan 5, 2022 and Jan 6, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 reports).

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

  • Insufficient Device Problem Information4
  • Off-Label Use2

Patient problems

  • Hernia4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 6, 2022Off-Label Use; Insufficient Device Problem Information; Off-Label Use; Insufficient Device Problem Information

    A PATIENT LOCATED OUTSIDE OF THE UNITED STATES UNDERWENT REPAIR OF AN EXTERNAL PELVIC ORGAN PROLAPSE WITH OVITEX R. THE PATIENT EXPERIENCED A RECURRENCE OF THIS EXTERNAL PROLAPSE. THIS IS ONE OF TWO REPORTS FROM THE SAME INVESTIGATOR INITATED STUDY.

    Patient problems: Hernia

    MAUDE report 13178951 ↗
  • InjuryJan 6, 2022Off-Label Use; Insufficient Device Problem Information; Off-Label Use; Insufficient Device Problem Information

    A PATIENT LOCATED OUTSIDE OF THE UNITED STATES UNDERWENT REPAIR OF AN EXTERNAL PELVIC ORGAN PROLAPSE WITH OVITEX R. THE PATIENT EXPERIENCED A RECURRENCE OF THIS EXTERNAL PROLAPSE. THIS IS ONE OF TWO REPORTS FROM THE SAME INVESTIGATOR INITIATED STUDY.

    Patient problems: Hernia

    MAUDE report 13178939 ↗
  • InjuryJan 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

    A PATIENT LOCATED OUTSIDE OF THE UNITED STATES UNDERWENT REPAIR OF AN EXTERNAL PELVIC ORGAN PROLAPSE WITH OVITEX R. THE PATIENT EXPERIENCED A RECURRENCE OF THIS EXTERNAL PROLAPSE. THIS IS ONE OF TWO REPORTS FROM THE SAME INVESTIGATOR INITATED STUDY.

    Patient problems: Hernia

    MAUDE report 13171022 ↗
  • InjuryJan 5, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

    A PATIENT LOCATED OUTSIDE OF THE UNITED STATES UNDERWENT REPAIR OF AN EXTERNAL PELVIC ORGAN PROLAPSE WITH OVITEX R. THE PATIENT EXPERIENCED A RECURRENCE OF THIS EXTERNAL PROLAPSE. THIS IS ONE OF TWO REPORTS FROM THE SAME INVESTIGATOR INITIATED STUDY.

    Patient problems: Hernia

    MAUDE report 13170992 ↗

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-0424-2019 · Apr 6, 2018 · Terminated
    OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G
  • Z-0430-2019 · Apr 6, 2018 · Terminated
    OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G
  • Z-0420-2019 · Apr 6, 2018 · Terminated
    OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G
  • Z-0425-2019 · Apr 6, 2018 · Terminated
    OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G
  • Z-0418-2019 · Apr 6, 2018 · Terminated
    OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G
  • Z-0432-2019 · Apr 6, 2018 · Terminated
    OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G
  • 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-0417-2019 · Apr 6, 2018 · Terminated
    OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G
  • Z-0419-2019 · Apr 6, 2018 · Terminated
    OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G
  • Z-0415-2019 · Apr 6, 2018 · Terminated
    OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G
  • Z-0426-2019 · Apr 6, 2018 · Terminated
    OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822G
  • Z-0422-2019 · Apr 6, 2018 · Terminated
    OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G
  • Z-0428-2019 · Apr 6, 2018 · Terminated
    OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G
  • Z-0433-2019 · Apr 6, 2018 · Terminated
    OviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020G

…and 6 more.

Other Mesh, Surgical devices

All Mesh, Surgical devices →

Sources and updates

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