VICRYL VWMLRecalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031056954), received between Jul 20, 2021 and Nov 12, 2024 — classified as 3 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 Problem3
Patient problems
- Adhesion(s)1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Insufficient Information1
- Necrosis1
- Scar Tissue1
- Unspecified Infection1
- Wound Dehiscence1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY AN ATTORNEY THAT ON (B)(6) 2019 THE PATIENT UNDERWENT OPEN PREPERITONEAL INGUINAL HERNIA REPAIR AND A MESH WAS IMPLANTED. NO ADDITIONAL INFORMATION CAN BE ADDED.
Patient problems: Insufficient Information
MAUDE report 20670812 ↗InjuryAug 22, 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 REPAIR OF RECURRENT INCISIONAL HERNIA AND MESH REMOVAL ON (B)(6) 2022 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT ABDOMINAL WOUND DEHISCENCE, EXTRACTION OF NECROTIC MESH AND WASHOUT OF THE WOUND ON (B)(6) 2022. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LARGE SCAR UNHEALED, INFECTED SORE IN THE UMBILICUS AND ADHESIONS. IT WAS REPORTED THAT PATIENT HAD HERNIA REPAIR SURGERY ON (B)(6) 2018 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT HAD RECURRENT HERNIA REPAIR SURGERY AND LAPAROTOMY WITH EXTENSIVE LYSIS OF ADHESION TOGETHER WITH AN ABDOMINAL ANTERIOR RELEASE ON (B)(6) 2018 DURING WHICH SURGEON NOTED CLOSED LOOP OBSTRUCTION CONTAINING SMALL BOWEL SECONDARY TO MESH, LARGE SCAR UNHEALED, INFECTED SORE IN THE UMBILICUS AND ADHESIONS. OTHER PROCEDURE WAS CAPTURED IN A SEPARATE FILE.
Patient problems: Adhesion(s); Necrosis; Scar Tissue; Unspecified Infection; Wound Dehiscence
MAUDE report 20041119 ↗InjuryJul 20, 2021Adverse 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) 2013 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN ADVERSE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 12200404 ↗
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- PROCEED PCDG1Johnson & Johnson International Inc. · Mesh, surgical, polymeric1 recall1 death637 reports
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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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