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VICRYL VKMLRecalls & reported problems

Ethicon Inc. · Undyed Knitted (Polyglactin 910), Synthetic Absorbable Mesh · Class 2 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
5
Deaths reported
0
Injuries reported
5
Recalls naming it
0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705031056909), received between Apr 9, 2018 and Jan 8, 2025 — classified as 5 injuries.

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 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 2 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem4
  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • Adhesion(s)2
  • Insufficient Information2
  • Diarrhea1
  • Fatigue1
  • Inflammation1
  • Injury1
  • Itching Sensation1
  • Local Reaction1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY AN ATTORNEY THAT PATIENT UNDERWENT HERNIA REPAIR ON (B)(6)2017 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Insufficient Information

    MAUDE report 21108426 ↗
  • InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2012 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT EXPERIENCED UNDISCLOSED INJURY. NO ADDITIONAL INFORMATION CAN BE PROVIDED.

    Patient problems: Insufficient Information

    MAUDE report 20584846 ↗
  • InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6)2016 AND TWO MESH WERE IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT REMOVAL SURGERY ON (B)(6)2016. PATIENT EXPERIENCED SEVERE INFLAMMATION, ADHESED SMALL BOWEL. IT WAS REPORTED THAT PATIENT HAD HERNIA SURGERY LAST (B)(6)2010 AND MESH WAS IMPLANTED AND HAD ANOTHER REPAIR LAST (B)(6)2012 AND MESH WAS IMPLANTED. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Adhesion(s); Inflammation

    MAUDE report 20378020 ↗
  • InjuryNov 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UMBILICAL HERNIA PROCEDURE ON (B)(6) 2020 AND THE MESH WAS IMPLANTED. IT WAS REPORTED THAT AFTER THE PROCEDURE THE PATIENT HAS EXPERIENCED ACHY JOINTS, EXTREME FATIGUE, TIREDNESS, UPSET STOMACH, DIARRHEA, NAUSEA, ITCHING AND HOTNESS IN STOMACH WHERE MESH WAS INSERTED.

    Patient problems: Adhesion(s); Diarrhea; Fatigue; Itching Sensation; Local Reaction; Nausea; Obstruction/Occlusion; Pain; Skin Irritation

    MAUDE report 10839930 ↗
  • InjuryApr 9, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A HERNIA REPAIR SURGERY ON (B)(6) 2014 AND MESH WAS IMPLANTED. NO ADDITIONAL INFORMATION PROVIDED.

    Patient problems: Injury

    MAUDE report 7406863 ↗

Other Mesh, surgical, polymeric devices

All Mesh, surgical, polymeric devices →

Sources and updates

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