Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control Recalled by American Medical Systems, Inc. Due to American Medical Systems, Inc. is initiating a recall...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact American Medical Systems, Inc. directly.
Affected Products
AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. The AMS 800¿ Urinary Control System is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence. It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra at the control of the patient. The AMS 800 system consists of three inter connected components: a cuff, a pump, and a pressure-regulating balloon. The three components are connected with kink-resistant tubing. The AMS 800 can be implanted at either the bulbous urethra or the bladder neck.
Quantity: 77
Why Was This Recalled?
American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary Control System, Control Pump & Pressure-Regulating Balloon. These products were released despite not meeting all final product release criteria.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About American Medical Systems, Inc.
American Medical Systems, Inc. has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report