Implanted Fecal Incontinence Device
FDA adverse event reports and recall history for implanted fecal incontinence device (product code MIP), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 436
- Deaths
- 0
- Injuries
- 326
- Malfunctions
- 105
Reports per year
Source: FDA adverse event reports by year received, 1994–2024. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2011-06-27TerminatedNonconforming Material/Component
AMS Acticon Neosphincter Pump, Product Number 72402287, Sterilization Method Steam, American Medical systems Inc., 10700 Bren Road West, Minnetonka, MN 55343. The Acticon Neosphincter is an implantable device used to treat severe fecal incontinence in males and females eighteen years and older who have failed, or are not candidates for less invasive forms of restorative therapy.
American Medical Systems is recalling all unexpired AMS 800 and AMS Acticon Neosphincter Control Pumps. Based upon a review of our product test procedures, we are unable to confirm that all Control Pumps have met our requirements. Test errors could potentially result in a failure to identify a malfunction in the Control Pump activation mechanism. This malfunction may lead to inadvertent activa
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