Versatex VTX1510X3Recalls & reported problems
Sofradim Production · Monofilament Mesh, Macroporous Polyester · Class 2 · Implant
All models of Versatex (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521532625), received between Jul 1, 2025 and Nov 20, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration or Expulsion of Device” (1 report).
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 Problem2
- Migration or Expulsion of Device1
- Patient Device Interaction Problem1
Patient problems
- Hernia2
- Pain2
- Unspecified Tissue Injury2
- Abscess1
- Anxiety1
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Cognitive Changes1
- Depression1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 20, 2025Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED MESH MIGRATE, PAIN, RECURRENCE, DISCOMFORT. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY, MEDICATION.
Patient problems: Discomfort; Hernia; Pain; Unspecified Tissue Injury
MAUDE report 23611175 ↗InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. THE PRODUCT WAS USED FOR THERAPEUTIC TREATMENT OF A HERNIA. IT WAS REPORTED THAT AFTER IMPLANT, THE PATIENT EXPERIENCED EMOTIONAL DISTRESS. POST-OPERATIVE PATIENT TREATMENT INCLUDED REVISION SURGERY.
Patient problems: Abscess; Anxiety; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cognitive Changes; Depression; Distress; Fistula; Foreign Body Reaction; Hematoma; Hemorrhage/Blood Loss/Bleeding; Hernia; High Blood Pressure/ Hypertension; Lethargy; Memory Loss/Impairment; Nerve Damage; Neuralgia; Pain; Perforation; Scar Tissue; Seroma; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 22376358 ↗
Other Mesh, Surgical, Polymeric devices
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- PROCEED PCDN1Johnson & Johnson International Inc. · Mesh, surgical, polymeric744 reports
- PROCEED PCDG1Johnson & Johnson International Inc. · Mesh, surgical, polymeric1 recall1 death637 reports
- PROCEED PVPSJohnson & Johnson International Inc. · Mesh, surgical, polymeric622 reports
- ProGrip LPG1510Sofradim Production · Mesh, surgical, polymeric2 deaths616 reports
- VENTRALEX 0010302Davol Inc. · Mesh, surgical, polymeric4 deaths531 reports
- BARD 0112680Davol Inc. · Mesh, surgical, polymeric1 death494 reports
- 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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