OviTex® PRS P20363-2025GRecalls & reported problems
Tela Bio, Inc. · The OviTex® PRS 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. The OviTex PRS Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device is permeable to facilitate fluid management, provides controlled stretch, and will incorporate into recipient tissue with associated cellular and microvascular ingrowth. Reinforced tissue matrices remodel into host tissue while maintaining compatibility with the body. The OviTex PRS Reinforced Tissue Matrix Device is for use in plastic and reconstructive surgery. · Class 2 · Implant
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 00810055070442), received between Nov 22, 2024 and Nov 5, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Disintegration” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Material Disintegration1
Patient problems
- Fluid Discharge2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 5, 2025Material Disintegration; Material Disintegration
A PATIENT UNDERWENT A BILATERAL BREAST RECONSTRUCTION PROCEDURE FOLLOWING BILATERAL MASTECTOMY ON (B)(6) 2025. IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED FLUID DISCHARGE THROUGH THE INCISION SIDE ON BOTH BREASTS. REOPERATION WAS CONDUCTED ON (B)(6) 2025 TO REMOVE PORTIONS OF THE OVITEX PRS DEVICES.
Patient problems: Fluid Discharge
MAUDE report 23476283 ↗InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A PATIENT UNDERWENT BILATERAL PREPECTORAL DIRECT TO IMPLANT BREAST RECONSTRUCTION WITH OVITEX PRS LTR AND BREAST IMPLANTS ON (B)(6) 2024. THE LEFT BREAST IMPLANT WAS REMOVED ON (B)(6) 2024 AFTER PRESENTING WITH DRAINAGE FROM THE INCISION SITE. THE RIGHT SIDE WAS UNAFFECTED.
Patient problems: Fluid Discharge
MAUDE report 20757148 ↗
Other Mesh, Surgical devices
- MEDPOR TITAN 81032Stryker Leibinger GmbH & Co. KG · Mesh, surgical1 recall1 report
- Peri-Guard PC1016NSynovis Life Technologies, Inc. · Mesh, surgical1 recall1 report
- SurgiMend® 606-200-020Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-005-001Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-300-008Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-200-016Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-300-021Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
- SurgiMend® 606-206-007Tei Biosciences Inc. · Mesh, surgical1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page