Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling
FDA adverse event reports and recall history for mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling (product code PAH), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 5,934
- Deaths
- 100
- Injuries
- 5,069
- Malfunctions
- 751
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2015-11-16TerminatedLabeling mix-ups
MiniArc Pro Single incision Sling System, Model number / Product Reference 9000261, Lot 936405xxx. Designed to treat female stress urinary incontinence.
The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box are placed on medical records and other documents associated with the procedure. Use of incorrectly identified labels may prevent direct traceability of the implanted unit in the future.
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