OviTex® PRS P20163-1620GRecalls & 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
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00810055070183), received between Mar 27, 2024 and Jan 17, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Material Disintegration” (4 reports).
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
- Material Disintegration4
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Fluid Discharge4
- Seroma1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJan 17, 2025Material Disintegration; Material Disintegration
IT WAS REPORTED THAT A PATIENT REQUIRED REOPERATION DUE TO UNEXPECTED DRAINAGE APPROXIMATELY ONE MONTH AFTER TWO STAGE BILATERIAL PRE-PECTORAL BREAST RECONSTRUCTION WITH OVITEX PRS LTR. DURING RE-OPERATION, THE SURGEON REMOVED THE REMAINING OVITEX PRS LTR AND REPLACED THE TISSUE EXPANDER.
Patient problems: Fluid Discharge
MAUDE report 21180490 ↗InjuryJan 17, 2025Material Disintegration; Material Disintegration
IT WAS REPORTED THAT A PATIENT REQUIRED REOPERATION DUE TO UNEXPECTED DRAINAGE APPROXIMATELY ONE MONTH AFTER TWO STAGE BILATERAL PRE-PECTORAL BREAST RECONSTRUCTION WITH OVITEX PRS LTR. DURING REOPERATION, THE SURGEON REMOVED THE REMAINING OVITEX PRS LTR AND REPLACED THE TISSUE EXPANDER.
Patient problems: Fluid Discharge
MAUDE report 21180488 ↗InjuryJan 17, 2025Material Disintegration; Material Disintegration
IT WAS REPORTED THAT A PATIENT REQUIRED REOPERATION DUE TO UNEXPECTED DRAINAGE APPROXIMATELY ONE MONTH AFTER TWO STAGE BILATERIAL PRE-PECTORAL BREAST RECONSTRUCTION WITH OVITEX PRS LTR. DURING REOPERATION, THE SURGEON REMOVED THE REMAINING OVITEX PRS LTR AND REPLACED THE TISSUE EXPANDER.
Patient problems: Fluid Discharge
MAUDE report 21180487 ↗InjuryOct 30, 2024Material Disintegration; Material Disintegration
IT WAS REPORTED THAT OVITEX PRS (LTR) WAS IMPLANTED ON (B)(6) 2024 TO REINFORCE SOFT TISSUE DURING AN EXPANDER TO BREAST IMPLANT EXCHANGE PROCEDURE. THE DEVICE WAS IMPLANTED AFTER ALLODERM HAD NOT COMPLETELY INCORPORATED. AFTER AN UNKNOWN DURATION (LESS THAN TWO MONTHS), THE PATIENT HAD DRAINAGE THROUGH THE INTRAMAMMARY FOLD INCISION. REOPERATION WAS CONDUCTED AND IT WAS NOTED THAT THE DEVICE HAD PARTIALLY RESORBED WITH ONLY THE SUTURE MATERIAL REMAINING, WHICH WAS REMOVED. THE PATIENT MOVED TO FINAL RECONSTRUCTION ON (B)(6) 2024.
Patient problems: Fluid Discharge
MAUDE report 20568544 ↗InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT BILATERAL PREPECTORAL BREAST RECONSTRUCTION WITH OVITEX PRS (LTR) AND TISSUE EXPANDERS ON 19JAN24. THE RIGHT BREAST PRESENTED WITH SEROMA AND THE OVITEX PRS (LTR) DEVICE AND TISSUE EXPANDER WERE REMOVED ON 23FEB24. THE PATIENT WAS RECOVERING AS OF 01MAR23 WITH NO ADDITIONAL ADVERSE EFFECTS NOTED.
Patient problems: Seroma
MAUDE report 18989539 ↗
Other Mesh, Surgical devices
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- 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.
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