GORE SYNECOR Biomaterial GKFR2030Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132635368), received between Aug 1, 2019 and Oct 14, 2022 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryMar 2, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6), 2005 WHEREBY A GORE® DUALMESH® PLUS BIOMATERIAL WAS IMPLANTED AND ON (B)(6), 2017 WHEREBY A GORE® SYNECOR® INTRAPERITONEAL BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6), 2016 AN ADDITIONAL PROCEDURE OCCURRED WHEREBY A GORE DEVICE WAS REVISED. THE COMPLAINT ALLEGES THAT ON (B)(6), 2017 AND (B)(6), 2018, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICES WERE EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: ADDITIONAL SURGERIES, PAIN, ADHESIONS, REVISION, BOWEL RESECTION, FISTULA, INFECTION, WOUND VAC, REMOVAL. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 13653564 ↗
• InjuryFeb 28, 2022Insufficient 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), 2019, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: RECURRENCE, ADHESIONS, ABSCESS OF ABDOMINAL WALL AND STOMACH. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 13624683 ↗
• InjuryApr 29, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INCISIONAL 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 THE PATIENT ALLEGES THE FOLLOWING INJURIES: INFECTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Erosion; Tissue Breakdown; Unspecified Infection

  MAUDE report 11749295 ↗
• InjurySep 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL HERNIA REPAIR ON (B)(6) 2016 WHEREBY A GORE® SYNECOR® INTRAPERITONEAL 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: HERNIA RECURRENCE, NECROSIS, INFECTION, SCARRING, INFLAMMATION, ADHESIONS. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 10593971 ↗
• InjuryAug 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC INCISIONAL HERNIA REPAIR ON (B)(6) 2017 WHEREBY A GORE® SYNECOR INTRAPERITONEAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2017, THE PATIENT DEVELOPED WOUND INFECTION WITH DEHISCENCE. THE COMPLAINT ALLEGES THAT ON (B)(6) 2018, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY EXCISIONAL DEBRIDEMENT OF WOUND EDGES WITH FASCIOCUTANEOUS FLAP CREATION OCCURRED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2018, ADDITIONAL PROCEDURES OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: WOUND INFECTION, WOUND DEHISCENCE, WOUND VAC, ADDITIONAL SURGICAL PROCEDURE, MESH REMOVAL, CHRONIC OPEN WOUND, SCAR, PURULENT DRAINAGE, INFLAMED SOFT TISSUE WITH ASSOCIATED MESH, MESH CONTRACTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Post Operative Wound Infection; Unspecified Infection; Wound Dehiscence

  MAUDE report 8912035 ↗
• 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: Hernia

  MAUDE report 8851457 ↗