GORE SYNECOR Preperitoneal Biomaterial GKWR2025Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132638727), received between Nov 4, 2019 and Sep 12, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING LITERATURE PUBLICATION WAS REVIEWED: ¿MAXIMIZING MESH MILEAGE: EVALUATING THE LONG-TERM PERFORMANCE OF A NOVEL HYBRID MESH FOR VENTRAL HERNIA REPAIR,¿ HERNIA, PP. 1¿9. SPURZEM, G.J. ET AL. (2024) MAXIMIZING MESH MILEAGE: EVALUATING THE LONG-TERM PERFORMANCE OF A NOVEL HYBRID MESH FOR VENTRAL HERNIA REPAIR DOI: 10.1007/S10029-024-02995-0. THIS RETROSPECTIVE, SINGLE-CENTER CASE REVIEW ANALYZED OUTCOMES IN 278 PREDOMINANTLY MALE PATIENTS WITH A MEAN AGE OF 57.8 YEARS WHO UNDERWENT VENTRAL HERNIA REPAIR (VHR) WITH GORE SYNECOR FROM MAY 2016 TO DECEMBER 2022. PRIMARY OUTCOMES WERE HERNIA RECURRENCE AND MESH INFECTION RATES. SECONDARY OUTCOMES WERE 30-DAY MORBIDITY, 30-DAY MORTALITY, 30-DAY READMISSION, RE-OPERATION, SURGICAL-SITE INFECTION (SSI) AND OCCURRENCE (SSO) RATES, AND OCCURRENCES REQUIRING INTERVENTION (SSOI). PROCEDURES WERE ACCOMPLISHED THROUGH OPEN APPROACH, ROBOTICALLY, AND LAPAROSCOPICALLY. MEAN HERNIA DEFECT SIZE WAS 63.4 CM2, WITH A MEAN LENGTH OF 7.9 CM AND MEAN WIDTH OF 6.0 CM. 93.2% OF CASES WERE CLEAN AND 37.8% REQUIRED COMPONENT SEPARATION. MESH WAS MOST COMMONLY PLACED INTRAPERITONEAL (41.4%), FOLLOWED BY RETRORECTUS (28.8%), PREPERITONEAL (19.8%), ON

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 20205019 ↗
• InjurySep 19, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED TO GORE THAT APPROXIMATELY THREE MONTHS AGO A 20 CM X 30 CM GORE® SYNECOR PREPERITONEAL BIOMATERIAL DEVICE WAS CUT IN HALF MAKING TWO 15 CM X 20 CM DEVICES TO REPAIR EACH SIDE OF THE BILATERAL HERNIA. ABSORBABLE VICRYL SUTURES WERE USED TO FIXATE BOTH PIECES. REPORTEDLY, THE PATIENT RETURNED TO THE OFFICE 1-2 WEEKS AGO COMPLAINING OF A LUMP IN HIS GROIN ON ONE SIDE. ON (B)(6) 2023 THE IMPLANTING PHYSICIAN RE-OPERATED ON THE PATIENT AND REPORTEDLY FOUND HEAVY SCAR TISSUE AND THE MESH SURROUNDED BY FLUID AND NOT INCORPORATED INTO TISSUE. THE MESH WAS EXPLANTED AND DISPOSED OF. THE HERNIA RECURRENCE WAS REPAIRED WITH A PIECE OF BARD 3D MAX.

  Patient problems: Seroma

  MAUDE report 17778024 ↗
• InjuryNov 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2019 WHEREBY A GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2019, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: OPEN DRAINING WOUND, MESH INFECTION, ABSCESS AND WOUND DEBRIDEMENT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Discharge; Tissue Breakdown; Unspecified Infection

  MAUDE report 9273506 ↗