GORE SYNECOR BiomaterialRecalls & reported problems across all models

We found 5 models of GORE SYNECOR Biomaterial by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between Oct 26, 2018 and May 5, 2026 — classified as 47 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (41 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GORE SYNECOR Biomaterial problems

GORE SYNECOR Biomaterial models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GORE SYNECOR Biomaterial GKFV1520

  Mesh, Surgical, Polymeric
  14 reports
• GORE SYNECOR Biomaterial GKFC12

  Mesh, Surgical, Polymeric
  13 reports
• GORE SYNECOR Biomaterial GKFV1015

  Mesh, Surgical, Polymeric
  8 reports
• GORE SYNECOR Biomaterial GKFR2030

  Mesh, Surgical, Polymeric
  7 reports
• GORE SYNECOR Biomaterial GKFR2025

  Mesh, Surgical, Polymeric
  5 reports

Recent GORE SYNECOR Biomaterial adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryMar 31, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, THE SURGEON USED THIS DEVICE DURING AN OPEN PARASTOMAL HERNIA REPAIR, SECURING THE MESH WITH TRANS FASCIAL SUTURES. THE SURGEON LATER REPORTED THAT, FOLLOWING IMPLANTATION, THE PATIENT DEVELOPED A SEROMA THAT BECAME ENCAPSULATED WITHIN THE MESH, CAUSING AN OBSTRUCTION AT THE STOMA SITE. DUE TO THIS OBSTRUCTION, THE SURGEON RETURNED TO THE OPERATING ROOM APPROXIMATELY TWO WEEKS POSTOPERATIVELY (AROUND ON (B)(6) 2026) AND REMOVED THE GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL MESH. BARD¿S PHASIX ST WAS IMPLANTED DURING THE SUBSEQUENT PROCEDURE, WHICH ALSO RESULTED IN AN UNKNOWN POSTOPERATIVE COMPLICATION. REPORTEDLY, THERE WAS NO MECHANICAL ISSUE AS IN FAILURE OR FRACTURING OF THE MESH AND NO DRAINS WERE USED. THERE WAS NO BINDER USED POST OPERATIVELY AS THE SURGEON NOTED THE PATIENT WAS IN A HOSPITAL BED FOR DAYS AFTER PROCEDURE AND MOVEMENT WAS LIMITED.

  Patient problems: Seroma

  MAUDE report 24747519 ↗
• 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 7, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN FLANK HERNIA REPAIR ON (B)(6) 2022 WHEREBY A GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2022, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTED MESH, BOWEL, COLON, OR OTHER ORGAN PERFORATION (LUNG). (B)(6) 2022 - POCKET OF PURULENT FLUID THAT WAS LOCATED SUPERIOR TO MESH AND SURROUND IT WAS SUCTIONED AND CULTURES WERE POSITIVE FOR AN INFECTION WITH GRAM + BACTERIA IN PAIRS. SYNECOR MESH WAS ¿INTIMATELY ADHERENT TO THE PARIETAL AND VISCERAL PLEURAE.¿ THE DISSECTION WAS DIFFICULT DUE TO SIGNIFICANT INGROWTH OF THE MESH. TWO AREAS OF UNDERLYING PARENCHYMAL INJURY WERE FOUND AND REPAIRED AFTER THE MESH WAS REMOVED. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 19481598 ↗
• 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 ↗
• 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 ROBOTIC ASSISTED PARASTOMAL HERNIA REPAIR ON (B)(6) 2020, WHEREBY A GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2022, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: HERNIA RECURRENCE, INTESTINAL BLOCKAGE, ORGAN PERFORATION, ADHESIONS, SMALL BOWEL OBSTRUCTION AND SEVERE PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Bowel Perforation; Erosion

  MAUDE report 16342676 ↗
• 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 ↗
• InjuryJan 5, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT UNKNOWN TYPE OF PROCEDURE FOR HERNIA REPAIR ON (B)(6) 2016 WHEREBY A GORE-TEX® SYNECORE MESH PLUS WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2020 AND (B)(6) 2020, ADDITIONAL PROCEDURES OCCURRED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: CHRONIC ABDOMINAL PAIN, INFECTION, ADHESION, FISSURES, ADDITIONAL SURGERIES.

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

  MAUDE report 16108797 ↗
• InjuryOct 14, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO GORE THAT AFTER A GORE® SYNECOR IP BIOMATERIAL WAS IMPLANTED THERE WAS A CENTRAL MIDLINE FAILURE OF THE MESH THAT RESULTED IN A RECURRENCE. REPORTEDLY, THE RECURRENCE WAS REPAIRED WITH A DIFFERENT MESH AND PATIENT IS DOING WELL. IT WAS REPORTED THAT ON SEPTEMBER 30TH (B)(6) TREATED THIS PATIENT USING A POLYPROPYLENE MESH FOR A RECURRENT HERNIA THAT WAS PREVIOUSLY TREATED. PRIOR TO 2018 THE PATIENT HAD A HERNIA REPAIR AT THE MIDLINE CLOSED PRIMARILY WITHOUT MESH REINFORCEMENT DURING A SLEEVE GASTRECTOMY. IN 2018 A HERNIA REPAIR WAS ABORTED DUE TO ADHESIONS. IN 2019 THE PATIENT WAS TREATED (NOT BY (B)(6)) FOR A RECURRENT MIDLINE INCISIONAL HERNIA. A 20X30CM SYNECOR IP DEVICE WAS TRIMMED TO 15X30CM AND INSERTED THROUGH A 12MM TROCAR AFTER CLOSING THE DEFECT WITH PERMANENT PROLENE SUTURES. THERE WAS NO MENTION OF DEVICE FIXATION. PRIOR TO THIS PROCEDURE THE PATIENT WAS TREATED WITH BOTOX TO RELAX THE ABDOMINAL MUSCLES TO ACHIEVE REAPPROXIMATION OF THE FASCIA BECAUSE THE HERNIA WAS LARGE. TWO WEEKS AFTER THE SYNECOR IMPLANT IN 2019, THE PATIENT RETURNED TO LOVELACE ER WITH A FEVER AND DIARRHEA AND LATER AN INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND STAYED

  Patient problems: Hernia; Unspecified Infection

  MAUDE report 15609005 ↗
• 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 ↗

Other W. L. Gore & Associates, Inc. products

• GORE EXCLUDER AAA Endoprosthesis81 models · 1,121 reports
• GORE DRYSEAL FLEX Introducer Sheath29 models · 1,009 reports
• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery51 models · 988 reports
• GORE DUALMESH PLUS BIOMATERIAL12 models · 734 reports
• GORE VIABAHN VBX Balloon Expandable Endo111 models · 557 reports · 1 recall
• GORE DUALMESH Biomaterial13 models · 485 reports
• GORE EXCLUDER Iliac Branch Endoprosthesis6 models · 469 reports
• GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral10 models · 427 reports