Virtue 50020Recalls & reported problems
Coloplast A/S · Male Sling System · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 05708932499149), received between Oct 3, 2023 and Jul 8, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Expiration Date Error” (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
- Expiration Date Error1
- Improper or Incorrect Procedure or Method1
- Material Frayed1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2026Material Twisted/Bent
ACCORDING TO THE AVAILABLE INFORMATION, DURING THE PROCEDURE, THE PHYSICIAN WAS USING THE INTRODUCER TO PASS THE SUTURE. UPON WITHDRAWING THE INTRODUCER, IT WAS NOTED THAT THE DEVICE HAD BENT AT THE LEVEL OF THE SECOND T-SLOT. NO ADDITIONAL ISSUES WERE NOTED DURING THE CASE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO IMPACT TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25751693 ↗MalfunctionAug 19, 2025Expiration Date Error; Expiration Date Error
ACCORDING TO THE AVAILABLE INFORMATION, THE VIRTUE RETAIL BOX AND INTRODUCER TRAY LABEL INDICATES AN EXPIRATION DATE OF 8/7/2025; HOWEVER, THE COMPONENT (ALEXIS RETRACTOR) INSIDE OF THE RETAIL BOX INDICATED AN EXPIRATION DATE OF 7/21/2025. SOLELY THE VIRTUE SLING WAS UTILIZED FROM THIS KIT. THE EXPIRED ALEXIS RETRACTOR WAS NOT USED ON THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22843623 ↗MalfunctionSep 4, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
ACCORDING TO THE AVAILABLE INFORMATION, THE VIRTUE WAS IMPLANTED 8 DAYS POST EXPIRATION DATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20140249 ↗MalfunctionOct 3, 2023Material Frayed; Material Frayed
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS FRAYED. THE SURGEON NOTED SLIGHT FRAYING IMMEDIATELY AFTER THE DEVICE WAS OPENED. ON PRIOR IMPLANTS, HE HAS NOT NOTICED THIS FRAYING OF THE DEVICES. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17860078 ↗
Other Mesh, surgical, for stress urinary incontinence, male devices
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- AdVance 720088-01American Medical Systems, Inc. · Mesh, Surgical, For Stress Urinary Incontinence, Male7 reports
- AdVance™ XP 720163-03Boston Scientific Corporation · Mesh, surgical, for stress urinary incontinence, male7 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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