GORE SYNECOR Biomaterial GKFC12Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00733132635344), received between Oct 26, 2018 and May 5, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2013, WHEREBY A GORE® SYNECOR® INTRAPERITONEAL BIOMATERIAL WAS IMPLANTED. IT WAS ALSO REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2019, WHEREBY A GORE® BIO-A® TISSUE REINFORCEMENT 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: HERNIA RECURRENCE, DENSE ADHESIONS, SEROMA. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Seroma

  MAUDE report 25085614 ↗
• InjuryAug 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC UMBILICAL HERNIA REPAIR ON (B)(6) 2021, WHEREBY A GORE® SYNECOR® INTRAPERITONEAL BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ON (B)(6) 2021; (B)(6), MD; BELLEVUE- LAPAROSCOPIC RECURRENT SYMPTOMATIC UMBILICAL HERNIA REPAIR WITH MESH. HERNIA DEFECT WITH OMENTUM REDUCED. ON (B)(6) 2022- REPAIR OF NONREDUCIBLE RECURRENT INCISIONAL HERNIA & REPAIR OF NONREDUCIBLE VENTRAL HERNIA (B)(6) 2022; (B)(6); (B)(6) MEDICAL CENTER; INJURIES- FIBROADIPOSE TISSUE WITH FIBROIDS, HEMORRHAGE, FOREIGN MATERIAL, FOREIGN BODY GIANT-CELL REACTION, RECURRENCE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia

  MAUDE report 22926149 ↗
• InjuryAug 19, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED APPROXIMATELY TWO WEEKS AGO (B)(6) 2025) THE GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL WAS IMPLANTED IN A ROBOTIC UMBILICAL HERNIA REPAIR. ON (B)(6) 2025, THAT PATIENT WENT TO THE EMERGENCY ROOM WITH AN INFECTION. THE PATIENT IS SCHEDULED FOR SURGERY (B)(6) 2025, TO REMOVE THE MESH. REPORTEDLY, THE SURGEON DOES NOT FEEL THE INFECTION WAS RELATED TO THE DEVICE. THE FIELD SALES ASSOCIATE REPORTED THE INFECTION WAS TREATED BY REMOVING THE MESH AND TREATED WITH WOUND VAC AND ANTIBIOTIC DRESSING.

  Patient problems: Unspecified Infection

  MAUDE report 22841828 ↗
• InjuryJul 8, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC UMBILICAL HERNIA REPAIR ON (B)(6) 2022 WHEREBY A GORE® SYNECOR® INTRAPERITONEAL BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2023, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: [ENTER INJURIES AS REPORTED]. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 19696245 ↗
• InjuryJun 5, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC HIATAL HERNIA REPAIR ON (B)(6) 2021 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: (B)(6) 2021 - LAPAROSCOPIC TAKEDOWN OF ADHESIONS, TAKEDOWN OF FUNDOPLICATION, EXCISION OF ERODED MESH AND DRAINAGE OF HIATAL ABSCESS AND CLOSURE OF DIAPHRAGMATIC HIATUS WITH A POSTERIOR RUNNING 2-0 PROLENE QUILL SUTURE. ¿USING THE SCISSORS, THE MESH WAS EXCISED FROM ADHESIONS TO THE ESOPHAGUS AND THE STOMACH AND WHILE DOING SO PURULENT MATERIAL AND PUS ARE DRAINED¿ HERE ALSO THERE IS LARGE AMOUNT OF MESH THAT HAS BEEN PARTIALLY ERODED INTO THE GASTRIC WALL, WHICH WAS COMPLETELY EXCISED.¿. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Dysphagia/ Odynophagia; Erosion; Unspecified Infection

  MAUDE report 19473554 ↗
• InjuryJul 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT AFTER AN UMBILICAL HERNIA REPAIR SURGERY ON (B)(6) 2020, WITH AN ALLEGED GORE® MESH DEVICE. THE PATIENT REPORTED THAT HE WAS SENT HOME FROM THE SURGERY CENTER AFTER HE TOLD THE NURSE HE WASN¿T FEELING RIGHT. AFTER APPROXIMATELY 5 HOURS OF PAIN AND DISCOMFORT AT HOME, HE WAS TAKEN TO THE VANDERBILT EMERGENCY ROOM WHERE THEY FOUND 3.5 LITERS OF BLOOD IN HIS ABDOMEN. THE DEVICE WAS REMOVED IN THE EARLY MORNING HOURS OF (B)(6) 2020. THE PATIENT REPORTED THAT HE WAS IN A COMA FOR 5 DAYS. THE PATIENT REPORTED THAT BECAUSE THIS HAPPENED DURING COVID HE WAS PLACED IN AN ICU BED. HE REPORTED THAT HE WAS IN THE HOSPITAL FOR 15 DAYS WITH A DRAIN PUT IN THAT WAS PAINFUL WHEN THEY WOULD SQUEEZE THE DRAIN TUBE AND THAT THEY TOOK THE DRAIN OUT 2 DAYS PRIOR TO DISCHARGING HIM. HE IS UNAWARE OF ANY INFECTIONS OR DIRECT ISSUES WITH THE MESH. HE STATED THE PHYSICIAN WHO REMOVED THE DEVICE WOULD NOT TELL HIM WHY THE DEVICE HAD TO BE REMOVED. IT WAS ALSO REPORTED THAT AFTER THE STRESS OF THE SURGERIES HIS PACEMAKER/DEFIBRILLATOR BEGAN HAVING ISSUES BROUGHT ON BY STRESS AND HE HAD IT REPLACED. HE ALSO STATED HE NOW HAS NON-ALCOHOLIC CIRRHOSIS OF THE LIVER WHICH HE STATED HE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17393199 ↗
• InjuryMay 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT A OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2017 WHEREBY A GORE® SYNECOR® INTRAPERITONEAL BIOMATERIAL WAS IMPLANTED. IT WAS ALSO REPORTED TO GORE THAT THE PATIENT UNDERWENT A SECOND OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2018 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: ADDITIONAL SURGERY, PAIN, REMOVAL, EXTENSIVE LYSIS OF ADHESIONS, MESH FOLDING, BOWEL OBSTRUCTION, HERNIA RECURRENCE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; Obstruction/Occlusion

  MAUDE report 16854900 ↗
• InjuryOct 25, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCARCERATED INCISIONAL HERNIA REPAIR ON (B)(6) 2018 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 THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERY, ADHESIONS, BOWEL RESECTION, HERNIA RECURRENCE, PAIN, MESH REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Adhesion(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 12691723 ↗
• InjuryJun 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2020, 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 THE PATIENT ALLEGES THE FOLLOWING INJURIES: OPEN DRAINING WOUND, SURGERY TO REMOVE MESH, INFECTION, ABSCESS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 12037437 ↗
• InjuryJun 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2018, 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 THE PATIENT ALLEGES THE FOLLOWING INJURIES: SEVERE AND CHRONIC PAIN/DISCOMFORT, MESH INFECTION, REMOVAL OF WALL SINUIS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 12036646 ↗
• InjuryJan 19, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC HIATAL HERNIA REPAIR ON (B)(6) 2017 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 THE PATIENT ALLEGES THE FOLLOWING INJURIES: SURGERY TO REMOVE MESH, HERNIA RECURRENCE, ADHESIONS, NERVE TRAPPED UNDER MESH, FOREIGN BODY GIANT CELL REACTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Dysphagia/ Odynophagia

  MAUDE report 11197933 ↗
• InjuryMay 15, 2020Use of Device Problem; Microbial Contamination of Device; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Microbial Contamination of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE BY THE FIELD SALES ASSOCIATE THAT APPROXIMATELY 5 WEEKS AGO THE SURGEON PERFORMED A LAP INCISIONAL HERNIA REPAIR, WHILE ALSO PERFORMING CONCOMITANT ILEOSTOMY AND COLOSTOMY TAKE DOWN AND PERIUMBILICAL HERNIA. THE SURGEON REPORTED ABOUT A WEEK AGO (4 WEEKS POST OP) THE PATIENT PRESENTED WITH A MESH INFECTION AND NECROTIZING FASCIITIS. THE SURGEON REMOVED THE TWO PIECES OF GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL. THE SURGEON REPORTED THERE WAS NO ADHESION ISSUES, BUT FELT THE BIOA LAYER REMAINED ON THE PERITONEUM. IT WAS REPORTED THE SURGEON WENT BACK IN THE PATIENT YESTERDAY AND SAID IT APPEARED THAT THE BIOA HAD NOW ADHERED TO THE BOWEL AND FISTULAS WERE PRESENT. REPORTEDLY, THE SURGEON WAS NOT CERTAIN THE FISTULAS WERE DUE TO THE BIOA AND HE WAS NOT CERTAIN THE INFECTION WAS DUE TO THE GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL. IT WAS REPORTED THE SURGEON WAS LOOKING FOR GUIDANCE AND TRYING TO PIECE THE INFORMATION TOGETHER.

  Patient problems: Fistula; Hernia; Unspecified Infection

  MAUDE report 10063515 ↗
• InjuryOct 26, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN RECONSTRUCTION OF THE ABDOMINAL WALL FOLLOWING BREAST RECONSTRUCTION ON (B)(6) 2017 WHEREBY A GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL. THE COMPLAINT ALLEGES THAT ON (B)(6) 2017, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY EXPLANT OF THE GORE DEVICE WAS PERFORMED. THE FOLLOWING WAS REPORTED: ¿AFTER IMPLANTATION THE MESH CONTRACTED, [SEPARATED] FROM THE RECTUS [FASCIA], AND BEGAN PROTRUDING THROUGH A WOUND THAT ABOUT TWO MONTHS AFTER IMPLANT. CONTRACTION IS VISIBLE ON PROTRUDING MESH IN PHOTOGRAPHS. SHE REQUIRED DEBRIDEMENT PROCEDURE ON (B)(6) AND UNDERWENT OPEN SURGERY ON (B)(6) 2017 TO REMOVE THE MESH AND TO PERFORM A PRIMARY REPAIR. SHE WAS DISCHARGED ON (B)(6). POST-OP, SHE HAD A WOUND VAC AND REQUIRED ANTIBIOTICS UNTIL (B)(6) 2018.¿ IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING PRODUCT DEFICIENCIES: CONTRACTION, INFECTION, RECURRENCE, AND MIGRATION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; No Code Available; Tissue Breakdown; Unspecified Infection

  MAUDE report 8009793 ↗