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
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 ↗
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- VENTRALEX 0010302Davol Inc. · Mesh, surgical, polymeric4 deaths531 reports
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- ProGrip TEM1509GSofradim Production · Mesh, surgical, polymeric3 deaths471 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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