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OviTex® 1S F10256-1012GRecalls & 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
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 09421904065307), received between Aug 22, 2022 and Aug 22, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 Information2

Patient problems

  • Device Embedded In Tissue or Plaque2
  • Dysphagia/ Odynophagia2
  • Obstruction/Occlusion2
  • Scar Tissue2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 22, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

    A PATIENT SELF-REPORTED COMPLICATIONS AFTER HIATAL HERNIA REPAIR WITH A TIF PROCEDURE IN FEBRUARY 2020 WITH OVITEX 1SR. THE PATIENT REPORTED EXPERIENCING DYSPHAGIA FOR APPROXIMATELY 10 MONTHS AND UNDERWENT ADDITIONAL SURGERY (TIME UNKNOWN). THE PATIENT REPORTED POTENTIAL DEVICE EMBEDMENT AND SCAR TISSUE AT THE ESOPHAGUS.

    Patient problems: Device Embedded In Tissue or Plaque; Dysphagia/ Odynophagia; Obstruction/Occlusion; Scar Tissue

    MAUDE report 15271915 ↗
  • InjuryAug 22, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

    A PATIENT SELF-REPORTED COMPLICATIONS AFTER HIATAL HERNIA REPAIR WITH A TIF PROCEDURE IN FEBRUARY 2020 WITH OVITEX 1SR. THE PATIENT REPORTED EXPERIENCING DYSPHAGIA FOR APPROXIMATELY 10 MONTHS AND UNDERWENT ADDITIONAL SURGERY (TIME UNKNOWN). THE PATIENT REPORTED POTENTIAL DEVICE EMBEDMENT AND SCAR TISSUE AT THE ESOPHAGUS.

    Patient problems: Device Embedded In Tissue or Plaque; Dysphagia/ Odynophagia; Obstruction/Occlusion; Scar Tissue

    MAUDE report 15265324 ↗

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-0426-2019 · Apr 6, 2018 · Terminated
    OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822G
  • Z-0417-2019 · Apr 6, 2018 · Terminated
    OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G
  • 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-0424-2019 · Apr 6, 2018 · Terminated
    OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G
  • Z-0431-2019 · Apr 6, 2018 · Terminated
    OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G
  • Z-0429-2019 · Apr 6, 2018 · Terminated
    OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
  • Z-0435-2019 · Apr 6, 2018 · Terminated
    OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
  • Z-0425-2019 · Apr 6, 2018 · Terminated
    OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G
  • Z-0430-2019 · Apr 6, 2018 · Terminated
    OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G
  • Z-0433-2019 · Apr 6, 2018 · Terminated
    OviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020G
  • Z-0434-2019 · Apr 6, 2018 · Terminated
    OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822G
  • Z-0416-2019 · Apr 6, 2018 · Terminated
    OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G
  • Z-0427-2019 · Apr 6, 2018 · Terminated
    OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G
  • Z-0432-2019 · Apr 6, 2018 · Terminated
    OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G

…and 6 more.

Other Mesh, Surgical devices

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Sources and updates

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