OviTex® LPR F10244-1212LRecalls & 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 09421904065772), received between Oct 15, 2024 and Jul 27, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 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
- Patient-Device Incompatibility2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Adhesion(s)3
- Obstruction/Occlusion3
- Abdominal Pain2
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
A patient underwent IPOM hernia repair to address a recurrent ventral hernia with primary closure obtained. Approximately six weeks later, the patient presented with a small bowel obstruction necessitating reoperation. During the procedure adhesions were noted and lysed. A separate internal hernia was discovered and repaired concomitantly.
Patient problems: Adhesion(s); Obstruction/Occlusion
MAUDE report 50024234 ↗InjuryOct 20, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
A PATIENT UNDERWENT INCISIONAL HERNIA REPAIR WITH INTRAPERITONEAL MESH PLACEMENT (IPOM) ON APPROXIMATELY (B)(6) 2024, USING OVITEX LPR FOR REINFORCEMENT. THE PATIENT RETURNED WITH ABDOMINAL PAIN AND A CT SCAN REVEALED A BOWEL OBSTRUCTION. AN EXPLORATORY LAPAROTOMY WAS PERFORMED AND THE SURGEON NOTED ADHESIONS REQUIRING REMOVAL OF THE DEVICE AND PARTIAL SMALL BOWEL RESECTION.
Patient problems: Abdominal Pain; Adhesion(s); Obstruction/Occlusion
MAUDE report 20490293 ↗InjuryOct 15, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
A PATIENT UNDERWENT INCISIONAL HERNIA REPAIR VIA INTRAPERITONEAL PLACEMENT OF MESH (IPOM) ON (B)(6) 2024 WITH OVITEX LPR PLACED AS REINFORCEMENT. THE PATIENT COMPLAINED OF ABDOMINAL PAIN APPROXIMATELY ONE WEEK LATER. APPROXIMATELY ONE WEEK AFTER PRESENTING WITH PAIN, CT SCAN REVEALED A BOWEL OBSTRUCTION. UPON EXPLORATORY LAPAROTOMY, ADHESIONS WERE NOTED. TAKEDOWN OF ADHESIONS REQUIRED DEVICE REMOVAL AND SOME SMALL BOWEL RESECTION. WHILE THE DEVICE WAS NOT NOTED AS DEFINITIVELY RELATED TO THIS INCIDENT, THIS EVENT IS BEING REPORTED IN AN ABUNDANCE OF CAUTION GIVEN THAT DEVICES OF THIS TYPE ARE ASSOCIATED WITH THE POTENTIAL COMPLICATION OF ADHESIONS.
Patient problems: Abdominal Pain; Adhesion(s); Obstruction/Occlusion
MAUDE report 20452305 ↗
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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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