GORE SYNECOR Biomaterial GKFR2025Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132635351), received between Aug 4, 2020 and Jun 7, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjurySep 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL/INCISIONAL HERNIA REPAIR ON (B)(6) 2020 WHEREBY A GORE® SYNECOR INTRAPERITONEAL BIOMATERIAL WAS IMPLANTED. THE COMPLAINT ALLEGES THAT ON (B)(6) 2020 AND (B)(6) 2021, ADDITIONAL PROCEDURES OCCURRED. THE COMPLAINT ALSO 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 SURGERIES, ABSCESS, DEBRIDEMENT, INCISION AND DRAINAGE, INFECTION, SEROMA, ADHESIONS, MESH FOLDING, HERNIA RECURRENCE, PAIN, MESH REMOVAL, WOUND VAC. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 12502661 ↗
• InjuryJul 20, 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) 2019, AN ADDITIONAL PROCEDURE OCCURRED WHEREBY THE GORE DEVICE WAS EXPLANTED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: RECURRENCE, REMOVAL OF MESH, ADHESIONS, SEROMA, BILATERAL COMPONENT SEPARATION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 12200399 ↗
• InjurySep 22, 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) 2019, AN ADDITIONAL PROCEDURE OCCURRED. IT WAS REPORTED THE PATIENT ALLEGES THE FOLLOWING INJURIES: HERNIA RECURRENCE; CHRONIC PAIN; MESH MIGRATION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Hernia; No Code Available

  MAUDE report 10570243 ↗
• InjuryAug 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT INCISIONAL HERNIA REPAIR ON (B)(6) 2017 WHEREBY A GORE®SYNECOR 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 AND INFECTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 10362635 ↗