OviTex® PRS R20152-2020GRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00856072005012), received between Nov 11, 2020 and Jan 11, 2024 — classified as 5 injuries.

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

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2024Material Disintegration; Material Disintegration

  A PATIENT UNDERWENT BILATERAL TWO-STAGE PRE-PECTORAL BREAST RECONSTRUCTION WITH OVITEX PRS AND TISSUE EXPANDERS. IT WAS REPORTED THAT A PATIENT EXPERIENCED UNILATERAL SEROMA RESULTING IN THE REMOVAL OF THE OVITEX PRS DEVICE AND THE TISSUE EXPANDER.

  Patient problems: Seroma

  MAUDE report 18492714 ↗
• InjuryDec 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT UNILATERAL DELAYED PREPECTORAL BREAST RECONSTRUCTION WITH OVITEX PRS PGA AND A TISSUE EXPANDER ON (B)(6) 23. APPROXIMATELY 3 WEEKS AFTER THE ORIGINAL SURGERY FIBRINOUS EXUDATE WAS NOTED IN THE POCKET. THE DEVICE WAS ADHERENT AND INTACT ALONG THE PERIMETER AND POSTERIOR BUT NOT PRESENT ANTERIORLY. THE DEVICES WERE EXPLANTED ON (B)(6) 2023.

  Patient problems: Fluid Discharge

  MAUDE report 18388824 ↗
• InjuryNov 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT BILATERAL PREPECTORAL BREAST RECONSTRUCTION WITH OVITEX PRS AND TISSUE EXPANDERS. IT WAS REPORTED THAT THE PATIENT PROGRESSED NORMALLY FOR A COUPLE OF WEEKS AND DRAINS WERE PULLED. DISCOLORATION APPEARED AROUND INCISIONS AND INCISIONS OPENED WITH FLUID DISCHARGE. ONE WOUND WAS REPORTED TO HAVE DEHISCED AND ALL DEVICES WERE REMOVED ON BOTH SIDES. THIS IS ONE OF TWO REPORTS FOR THE SAME PATIENT FOR THIS ISSUE.

  Patient problems: Fluid Discharge; Wound Dehiscence

  MAUDE report 18059303 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT TWO-STAGE BILATERAL BREAST RECONSTRUCTION WITH TISSUE EXPANDERS AND OVITEX PRS PGA ON APPROXIMATELY (B)(6) 2023. IT WAS REPORTED THAT ON (B)(6) 2023 THE OVITEX PRS DEVICES HAD POSSIBLY BROKEN DOWN AND EXTRUDED THROUGH THE PATIENT'S INCISIONS. THE DEVICES WERE REMOVED TO THE EXTENT POSSIBLE, TISSUE EXPANDERS LEFT IN PLACE, AND RECONSTRUCTION COURSE CONTINUED.

  Patient problems: Fluid Discharge

  MAUDE report 17961040 ↗
• InjuryNov 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT UNDERWENT A UNILATERAL (LEFT) MASTECTOMY AND PREFECTORAL TWO-STAGE BREAST RECONSTRUCTION WITH A TEXTURED TISSUE EXPANDER AND OVITEX PRS. THE EXPANDER AND OVITEX PRS WERE IMPLANTED ON (B)(6) 2020. THE PATIENT RETURNED ON (B)(6) 2020 FOR AN UNKNOWN FOLLOW-UP SURGICAL PROCEDURE. UPON OPENING THE INCISION, THE SURGEON NOTED THAT PORTIONS OF THE OVINE TISSUE WERE NO LONGER PRESENT AT THE SURGICAL SITE. THE SURGEON REMOVED THE OVITEX PRS AND LEFT THE EXPANDER INSERTED.

  Patient problems: No Information

  MAUDE report 10822213 ↗