GORE SYNECOR Biomaterial GKFV1015Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132635382), received between Feb 28, 2020 and Apr 5, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2023Insufficient 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 A GORE® SYNECOR® INTRAPERITONEAL BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2018, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTED MESH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 16686684 ↗
• InjuryFeb 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2019 WHEREBY A GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2021 THE GORE DEVICE WAS EXPLANTED AND ON (B)(6) 2022, AN ADDITIONAL PROCEDURES OCCURRED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: HERNIA RECURRENCE, INTESTINAL BLOCKAGE, FLUID BUILD UP AT SURGICAL SITE, FISTULAS, DEBRIDEMENT, IRRIGATION AND SEVERE PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Erosion

  MAUDE report 16341412 ↗
• InjuryOct 13, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC PARASTOMAL HERNIA REPAIR ON (B)(6) 2018 WHEREBY A GORE® SYNECOR® INTRAPERITONEAL BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2018, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE® SYNECOR® INTRAPERITONEAL BIOMATERIAL WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERY; RECURRENCE; ADHESIONS; MESH MIGRATION; MESH REMOVAL; EXTENSIVE REDUNDANT SKIN; BOWEL OBSTRUCTION; PAIN & SUFFERING. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED. THE MEDICAL RECORDS SHOW THAT THE PATIENT UNDERWENT LAPAROSCOPIC PARASTOMAL HERNIA REPAIR ON (B)(6) 2018 WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT WAS IMPLANTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15594875 ↗
• InjuryJan 31, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL HERNIA REPAIR ON (B)(6), 2020 WHEREBY A GORE® SYNECOR® INTRAPERITONEAL BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6), 2021, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: EROSION INTO BOWEL, FISTULA, MESH INFECTION, AND EXPLANT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 13401501 ↗
• InjuryFeb 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2019 WHEREBY TWO GORE® SYNECOR INTRAPERITONEAL BIOMATERIALS 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: ADHESIONS TO BOWEL, HERNIA RECURRENCE, ADHESIONS, LOOPS OF BOWEL ADHERENT TO MESH, BOWEL OBSTRUCTION/ COMPLICATIONS, SEVERE AND CHRONIC PAIN/ DISCOMFORT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 11378951 ↗
• InjuryJan 6, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN PERIUMBILICAL HERNIA REPAIR ON (B)(6) 2018 WHEREBY A GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2018, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH CONTRACTION, MESH DETACHMENT, SURGERY TO REMOVE MESH, BOWEL BLOCKAGE, TROUBLE EATING, SEVERE AND CHRONIC PAIN/DISCOMFORT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 11125180 ↗
• InjuryNov 3, 2020Insufficient 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) 2020, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED ON (B)(6) 2021 THE PATIENT ALLEGES THE FOLLOWING INJURIES: SEVERE AND CHRONIC PAIN/DISCOMFORT, SURGERY TO REMOVE MESH, EXTENSIVE ADHESIONS, ABDOMINAL WALL DEBRIDEMENT, ABDOMINAL FLUID COLLECTION.

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

  MAUDE report 10779118 ↗
• InjuryFeb 28, 2020Insufficient 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 A GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2018 AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: "ON (B)(6) 2018, AN EXPLORATORY LAPAROTOMY WITH EXPLANTATION OF PREVIOUS HERNIA MESH AND REPAIR OF SMALL BOWEL PERFORATION. AT THE TIME OF THIS SURGERY, (B)(6) CONDITION WAS NOTED TO BE CRITICAL. FURTHER, (B)(6) WAS DIAGNOSED WITH SEPSIS DUE TO AN UNSPECIFIED ORGANISM." FOUR DAYS AFTER HER INITIAL DISCHARGE, SHE RETURNED "WITH SEVERE POSTPRANDIAL ABDOMINAL PAIN, NAUSEA AND VOMITING." ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Bowel Perforation; No Clinical Signs, Symptoms or Conditions; No Code Available; Pain; Seroma

  MAUDE report 9771041 ↗