GORE SYNECOR Preperitoneal Biomaterial GKWV1015Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132638741), received between Sep 21, 2021 and May 28, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED BY THE PRODUCT SPECIALIST THAT, ON (B)(6) 2025, HE HAD A CONVERSATION WITH (B)(6) (GORE SURGICAL SOLUTIONS FIELD SALES ASSOCIATE) WHO TOLD HIM ABOUT A MESH FRACTURE OF GORE® SYNECOR PREPERITONEAL BIOMATERIAL. ON (B)(6) 2025, THE PS HAD A PHONE CONVERSATION WITH DR. (B)(6) TO DISCUSS WHAT HE OBSERVED. ACCORDING TO DR (B)(6), HE HAS A MALE PATIENT 74 YEARS WHO WAS IMPLANTED SEVEN YEARS AGO WITH SYNECOR PRE FOR AN INGUINAL HERNIA REPAIR, SUTURING THE MESH TO THE PUBIC BONE WITH 2-0 VICRYL SUTURE. THE PHYSICIAN REPORTED HIS PATIENT IS AN AVID WEIGHTLIFTER, ALWAYS IN THE GYM DOING CORE WORK OUTS. REPORTEDLY, ONE DAY THE PATIENT WAS DOING SQUAT LIFTS AND FELT A TEAR IN HIS GROIN. ON (B)(6) 2025, DR (B)(6) OPERATED ON THE PATIENT TO DETERMINE WHAT HAPPENED. THE PHYSICIAN OBSERVED THAT THE MESH TORE FROM THE PUBIC BONE WHERE IT WAS FIXATED. HE DESCRIBED IT SPECIFICALLY AS ¿I SAW MESH, THEN TISSUE, THEN MESH.¿ IT WAS AN INDIRECT RECURRENCE. THE PHYSICIAN DID NOT TAKE ANY PHOTOS OR VIDEOS AND DID NOT EXPLANT THE DEVICE. HE PLACED ANOTHER PIECE OF SYNECOR PRE OVER THE OLD PIECE TO REPAIR THE HERNIA. REPORTEDLY, THERE WAS NO SUBSEQUENT PROCEDURES IN THE AREA OF THE DEVICE AFTER

  Patient problems: Hernia

  MAUDE report 22095605 ↗
• InjuryJul 15, 2024Insufficient 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® PREPERITONEAL 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: DEATH (B)(6) 2022 - BOWEL OBSTRUCTION, ADHESIONS, PAIN, INFECTION, CHRONIC WOUND. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 19742053 ↗
• InjuryApr 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2021 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, SEPSIS, SEROMA, WOUND VAC, ABSCESS, NECROSIS, 12-DAY HOSPITAL STAY. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 19132959 ↗
• InjurySep 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN VENTRAL/INCISIONAL HERNIA REPAIR ON (B)(6) 2018 WHEREBY A GORE® DUALMESH® PLUS 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: FOREIGN BODY GIANT CELL REACTION, MESH DETACHMENT, INFECTION, HERNIA RECURRENCE, SURGERY TO REMOVE MESH, AND SEVERE AND CHRONIC PAIN/DISCOMFORT. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 12509519 ↗