GORE SYNECOR Preperitoneal Biomaterial GKWR2030Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00733132638734), received between Aug 2, 2019 and Sep 12, 2024 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING LITERATURE PUBLICATION WAS REVIEWED: ¿MAXIMIZING MESH MILEAGE: EVALUATING THE LONG-TERM PERFORMANCE OF A NOVEL HYBRID MESH FOR VENTRAL HERNIA REPAIR,¿ HERNIA, PP. 1¿9. SPURZEM, G.J. ET AL. (2024) MAXIMIZING MESH MILEAGE: EVALUATING THE LONG-TERM PERFORMANCE OF A NOVEL HYBRID MESH FOR VENTRAL HERNIA REPAIR DOI: 10.1007/S10029-024-02995-0. THIS RETROSPECTIVE, SINGLE-CENTER CASE REVIEW ANALYZED OUTCOMES IN 278 PREDOMINANTLY MALE PATIENTS WITH A MEAN AGE OF 57.8 YEARS WHO UNDERWENT VENTRAL HERNIA REPAIR (VHR) WITH GORE SYNECOR FROM MAY 2016 TO DECEMBER 2022. PRIMARY OUTCOMES WERE HERNIA RECURRENCE AND MESH INFECTION RATES. SECONDARY OUTCOMES WERE 30-DAY MORBIDITY, 30-DAY MORTALITY, 30-DAY READMISSION, RE-OPERATION, SURGICAL-SITE INFECTION (SSI) AND OCCURRENCE (SSO) RATES, AND OCCURRENCES REQUIRING INTERVENTION (SSOI). PROCEDURES WERE ACCOMPLISHED THROUGH OPEN APPROACH, ROBOTICALLY, AND LAPAROSCOPICALLY. MEAN HERNIA DEFECT SIZE WAS 63.4 CM2, WITH A MEAN LENGTH OF 7.9 CM AND MEAN WIDTH OF 6.0 CM. 93.2% OF CASES WERE CLEAN AND 37.8% REQUIRED COMPONENT SEPARATION. MESH WAS MOST COMMONLY PLACED INTRAPERITONEAL (41.4%), FOLLOWED BY RETRORECTUS (28.8%), PREPERITONEAL (19.8%), ON

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 20207438 ↗
• InjurySep 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING LITERATURE PUBLICATION WAS REVIEWED: ¿MAXIMIZING MESH MILEAGE: EVALUATING THE LONG-TERM PERFORMANCE OF A NOVEL HYBRID MESH FOR VENTRAL HERNIA REPAIR,¿ HERNIA, PP. 1¿9. SPURZEM, G.J. ET AL. (2024). MAXIMIZING MESH MILEAGE: EVALUATING THE LONG-TERM PERFORMANCE OF A NOVEL HYBRID MESH FOR VENTRAL HERNIA REPAIR DOI: 10.1007/S10029-024-02995-0. THIS RETROSPECTIVE, SINGLE-CENTER CASE REVIEW ANALYZED OUTCOMES IN 278 PREDOMINANTLY MALE PATIENTS WITH A MEAN AGE OF 57.8 YEARS WHO UNDERWENT VENTRAL HERNIA REPAIR (VHR) WITH GORE SYNECOR FROM MAY 2016 TO DECEMBER 2022. PRIMARY OUTCOMES WERE HERNIA RECURRENCE AND MESH INFECTION RATES. SECONDARY OUTCOMES WERE 30-DAY MORBIDITY, 30-DAY MORTALITY, 30-DAY READMISSION, RE-OPERATION, SURGICAL-SITE INFECTION (SSI) AND OCCURRENCE (SSO) RATES, AND OCCURRENCES REQUIRING INTERVENTION (SSOI). PROCEDURES WERE ACCOMPLISHED THROUGH OPEN APPROACH, ROBOTICALLY, AND LAPAROSCOPICALLY. MEAN HERNIA DEFECT SIZE WAS 63.4 CM2, WITH A MEAN LENGTH OF 7.9 CM AND MEAN WIDTH OF 6.0 CM. 93.2% OF CASES WERE CLEAN AND 37.8% REQUIRED COMPONENT SEPARATION. MESH WAS MOST COMMONLY PLACED INTRAPERITONEAL (41.4%), FOLLOWED BY RETRORECTUS (28.8%), PREPERITONEAL (19.8%), O

  Patient problems: Unspecified Infection

  MAUDE report 20201414 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING LITERATURE PUBLICATION WAS REVIEWED: ¿MAXIMIZING MESH MILEAGE: EVALUATING THE LONG-TERM PERFORMANCE OF A NOVEL HYBRID MESH FOR VENTRAL HERNIA REPAIR,¿ HERNIA, PP. 1¿9. SPURZEM, G.J. ET AL. (2024). MAXIMIZING MESH MILEAGE: EVALUATING THE LONG-TERM PERFORMANCE OF A NOVEL HYBRID MESH FOR VENTRAL HERNIA REPAIR DOI: 10.1007/S10029-024-02995-0. THIS RETROSPECTIVE, SINGLE-CENTER CASE REVIEW ANALYZED OUTCOMES IN 278 PREDOMINANTLY MALE PATIENTS WITH A MEAN AGE OF 57.8 YEARS WHO UNDERWENT VENTRAL HERNIA REPAIR (VHR) WITH GORE SYNECOR FROM MAY 2016 TO DECEMBER 2022. PRIMARY OUTCOMES WERE HERNIA RECURRENCE AND MESH INFECTION RATES. SECONDARY OUTCOMES WERE 30-DAY MORBIDITY, 30-DAY MORTALITY, 30-DAY READMISSION, RE-OPERATION, SURGICAL-SITE INFECTION (SSI) AND OCCURRENCE (SSO) RATES, AND OCCURRENCES REQUIRING INTERVENTION (SSOI). PROCEDURES WERE ACCOMPLISHED THROUGH OPEN APPROACH, ROBOTICALLY, AND LAPAROSCOPICALLY. MEAN HERNIA DEFECT SIZE WAS 63.4 CM2, WITH A MEAN LENGTH OF 7.9 CM AND MEAN WIDTH OF 6.0 CM. 93.2% OF CASES WERE CLEAN AND 37.8% REQUIRED COMPONENT SEPARATION. MESH WAS MOST COMMONLY PLACED INTRAPERITONEAL (41.4%), FOLLOWED BY RETRORECTUS (28.8%), PREPERITONEAL (19.8%), O

  Patient problems: Abscess; Unspecified Infection; Wound Dehiscence

  MAUDE report 20183603 ↗
• InjuryJul 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING LITERATURE PUBLICATION WAS REVIEWED: ¿MAXIMIZING MESH MILEAGE: EVALUATING THE LONG-TERM PERFORMANCE OF A NOVEL HYBRID MESH FOR VENTRAL HERNIA REPAIR,¿ HERNIA, PP. 1¿9. SPURZEM, G.J. ET AL. (2024). MAXIMIZING MESH MILEAGE: EVALUATING THE LONG-TERM PERFORMANCE OF A NOVEL HYBRID MESH FOR VENTRAL HERNIA REPAIR. DOI: 10.1007/S10029-024-02995-0. THIS RETROSPECTIVE, SINGLE-CENTER CASE REVIEW ANALYZED OUTCOMES IN 278 PREDOMINANTLY MALE PATIENTS WITH A MEAN AGE OF 57.8 YEARS WHO UNDERWENT VENTRAL HERNIA REPAIR (VHR) WITH GORE SYNECOR FROM MAY 2016 TO DECEMBER 2022. PRIMARY OUTCOMES WERE HERNIA RECURRENCE AND MESH INFECTION RATES. SECONDARY OUTCOMES WERE 30-DAY MORBIDITY, 30-DAY MORTALITY, 30-DAY READMISSION, RE-OPERATION, SURGICAL-SITE INFECTION (SSI) AND OCCURRENCE (SSO) RATES, AND OCCURRENCES REQUIRING INTERVENTION (SSOI). PROCEDURES WERE ACCOMPLISHED THROUGH OPEN APPROACH, ROBOTICALLY, AND LAPAROSCOPICALLY. MEAN HERNIA DEFECT SIZE WAS 63.4 CM2, WITH A MEAN LENGTH OF 7.9 CM AND MEAN WIDTH OF 6.0 CM. 93.2% OF CASES WERE CLEAN AND 37.8% REQUIRED COMPONENT SEPARATION. MESH WAS MOST COMMONLY PLACED INTRAPERITONEAL (41.4%), FOLLOWED BY RETRORECTUS (28.8%), PREPERITONEAL (19.8%),

  Patient problems: Hematoma; No Clinical Signs, Symptoms or Conditions; Purulent Discharge

  MAUDE report 19775966 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE BY THE FIELD SALES ASSOCIATE THAT A HERNIA REPAIR WAS PERFORMED ON (B)(6) 2023. THE CASE WAS A ROBOTIC ETEP WITH BILATERAL TAR, PATIENT HAD PRIOR MESH IN THE INTRAPERITONEAL PLANE THAT WAS LEFT INTACT AS A POSTERIOR SHEATH. THE PHYSICIAN IMPLANTED A LARGE PIECE OF GORE® SYNECOR PREPERITONEAL BIOMATERIAL DURING THIS PROCEDURE. APPROXIMATELY 6-7 MONTHS AFTER THE CASE THE PATIENT PRESENTED WITH A SEROMA, CHRONIC SINUS WITH GRANULATION AND PUS. THE PHYSICIAN BOOKED THIS PATIENT FOR A EXPLORATION ON (B)(6) 2023. IN THIS CASE, HE FOUND WHAT HE THOUGHT TO BE OLD VENTRALEX (PROLENE AND PTFE) AND EXCISED COMPLETELY. THE BULK OF THE INFECTION WAS ON THE VENTRALEX AND PROLENE SUTURES. A LITTLE BIT OF SYNECOR FROM THE EDGE OF THE MESH WAS REMOVED. AFTER THIS CASE WE WENT BACK TO HIS OFFICE AND LOOKED AT THE CT SCAN FROM PRIOR TO THE (B)(6) 2023 CASE WHICH DID NOT SHOW PRIOR INFECTION. WE THEN WATCHED THE RECORDING OF HIS OPERATION FROM (B)(6) 2023 TO SEE HOW THE PRIOR MESH LOOKED INTEROP AND DID NOT SEE ANYTHING OUT OF THE ORDINARY. IT WAS FURTHER REPORTED, THE DEVICE IS NOT AVAILABLE FOR EXAMINATION IT WAS DISCARDED AT THE HOSPITAL. THERE WAS ONE JP DRAIN USED AND THE

  Patient problems: Seroma; Unspecified Infection

  MAUDE report 17909117 ↗
• 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 12509376 ↗
• InjurySep 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT OPEN INSICIONAL HERNIA REPAIR ON (B)(6)2018 WHEREBY A GORE® SYNECOR PREPERITONEAL 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: PARTIALLY UNINCORPORATED MESH, PARTIAL MESH REMOVAL, NECROSIS, FOREIGN BODY GIANT CELL REACTION, INFLAMMATION, INFECTION, OPEN DRAINING WOUND. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 10584245 ↗
• InjuryDec 9, 2019Insufficient 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 TWO GORE® SYNECOR PREPERITONEAL BIOMATERIAL 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: INFECTION, SURGERY TO REMOVE MESH, BOWEL RESECTION. ADDITIONAL EVENT SPECIFIC INFORMATION WAS NOT PROVIDED.

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

  MAUDE report 9436833 ↗
• InjuryAug 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE GORE FIELD SALES ASSOCIATE THAT THE PHYSICIAN PLACED THE GORE® SYNECOR PREPERITONEAL BIOMATERIAL IN THE RETRO RECTUS. THE MESH WAS SUTURED IN PLACE, NO DRAINS WERE USED AND A 2 ML FIBRIN SEALANT WAS USED. THE PHYSICIAN STATED THE PATIENT COMPLAINED OF PAIN A FEW WEEKS LATER. THE PATIENT RETURNED TO THE OPERATING ROOM WHERE THE PHYSICIAN REPORTED LARGE SEROMA AND FLUID SURROUNDING THE MESH. AN EXPLANT WAS PERFORMED. THE PATIENT IS REPORTED TO BE DOING WELL AT HOME NOW.

  Patient problems: Seroma

  MAUDE report 8856257 ↗