GORE SYNECOR Biomaterial GKFV1520Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00733132635375), received between Nov 13, 2018 and Mar 31, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 22, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2007 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON(B)(6) 2017, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: MESH REMOVAL, PAIN, ADHESIONS, WOUND VAC, ADDITIONAL SURGERY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 12682599 ↗
• InjuryAug 20, 2021Insufficient 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. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERY, ADHESIONS, HERNIA RECURRENCE, PAIN, REVISION, MESH FAILURE. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hematoma; Seroma

  MAUDE report 12349482 ↗
• InjuryMar 24, 2021Insufficient 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) 2019 AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION, BOWEL RESECTION, BOWEL PERFORATION, ADHESIONS TO SMALL INTESTINE, ADHESIONS TO BOWEL, ADHESIONS, SURGERY TO REMOVE MESH, ABSCESS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 11564145 ↗
• InjuryMar 23, 2021Insufficient 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® 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: DEBRIDEMENT, INFECTION, WOUND VAC, MESH REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 11558597 ↗
• InjuryFeb 24, 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 11374936 ↗
• 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 10063512 ↗
• InjuryMar 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN UPPER ABDOMINAL HERNIA REPAIR ON (B)(6) 2018 WHEREBY TWO [2] SYNECOR OVAL (15 X 20 CM) WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2018 AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2019, AN ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: SURGERY TO REMOVE MESH, INFECTION, FISTULA, ABSCESS, OPEN DRAINING WOUND, DRAINING SINUS, SEVERE AND CHRONIC ABDOMINAL PAIN, SPASMS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 9830533 ↗
• InjuryMar 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN UPPER ABDOMINAL HERNIA REPAIR ON (B)(6) 2018 WHEREBY TWO [2] SYNECOR OVAL (15 X 20 CM) WERE IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2018 AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. 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: SURGERY TO REMOVE MESH, INFECTION, FISTULA, ABSCESS, OPEN DRAINING WOUND, DRAINING SINUS, SEVERE AND CHRONIC ABDOMINAL PAIN, SPASMS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 9830508 ↗
• InjuryFeb 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT UMBILICAL HERNIA REPAIR ON (B)(6) 2018 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: INFECTION AND CHRONIC PAIN. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 9694392 ↗
• InjuryAug 1, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT ABDOMINAL PANNICULECTOMY, LEFT RECTUS ABDOMINUS INTERNAL OBLIQUE AND TRANSVERSUS ABDOMINIS MUSCULOFASCIAL ADVANCEMENT FLAP, RIGHT RECTUS ABDOMINUS INTERNAL OBLIQUE AND TRANSVERSUS ABDOMINIS MUSCULOFASCIAL ADVANCEMENT FLAP, EXPLORATORY LAPAROTOMY WITH LYSIS OF ADHESIONS WITH A RIGHT HEMICOLECTOMY WITH ILEOCOLIC ANASTOMOSIS AND OMENTECTOMY, COMPLEX ABDOMINAL WALL INCISIONAL HERNIA, RECURRENT REPAIR WITH BILATERAL ANTERIOR COMPONENT SEPARATION, AND EXCISION OF SCAR, OLD MESH AND FOREIGN BODY ON (B)(6) 2016 WHEREBY A GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT ROBOTIC ASSISTED VENTRAL HERNIA REPAIR WITH MESH OF INCARCERATED VENTRAL HERNIA AND ROBOTIC ASSISTED ADHESIOLYSIS ON (B)(6) 2017 WHEREBY A GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT ROBOTIC ASSISTED INCISIONAL HERNIA REPAIR WITH MESH AND ROBOTIC LYSIS OF ADHESIONS, EXTENSIVE, ON (B)(6) 2018 WHEREBY A GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON JUNE 7, 2018 AN ADDITIONAL PROCEDURE OCCURRED WHEREBY MOST OF THE GO

  Patient problems: Adhesion(s); Hernia

  MAUDE report 8851464 ↗
• InjuryNov 13, 2018No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2015, WHEREBY A GORE DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED. IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT HERNIA REPAIR (TYPE UNKNOWN) ON (B)(6) 2016, WHEREBY A GORE® SYNECOR BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2016, AN ADDITIONAL PROCEDURE WAS PERFORMED WHEREBY EXPLANT OF THE GORE DEVICE WAS PERFORMED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2018, AN ADDITIONAL PROCEDURE WAS PERFORMED WHEREBY EXPLANT OF THE GORE DEVICE WAS PERFORMED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERY, EXTENSIVE LYSIS OF ADHESIONS, RECURRENT HERNIA, MESH FAILURE, MESH REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Adhesion(s); Hernia; No Code Available; Not Applicable

  MAUDE report 8063851 ↗