GORE SYNECOR Preperitoneal Biomaterial GKWV1520Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132638758), received between Dec 9, 2019 and Jul 16, 2024 — classified as 3 injuries.

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

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.

• InjuryJul 16, 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: Hematoma; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19757196 ↗
• InjurySep 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2018 WHEREBY A GORE® SYNECOR® PREPERITONEAL BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2019 AND (B)(6) 2019, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: HERNIA RECURRENCE; CHRONIC PAIN; INFECTION, SEROMA, DEBRIDEMENT, WOUND VAC TREATMENT, MESH REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 10568461 ↗
• InjuryDec 9, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2018 WHEREBY TWO GORE® SYNECOR PREPERITONEAL BIOMATERIAL WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2019 AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, SURGERY TO REMOVE MESH, BOWEL RESECTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion; Unspecified Infection

  MAUDE report 9436831 ↗