🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: March 1, 2013 American Medical Systems Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Model # Lot # 72400024 771029003 72400024 794405011 72400024 744211005 72400024 794405007 72400024 744211008 72400024 771029001 72400024 794405006 72400024 771029005 72400024 744211009 72400024 771029016 72400023 741419006 72400024 794405001 72400024 794405002 72400024 794405004 72400024 794405005 72400024 794405015 72400024 794405016 72400024 744211001 72400024 744211004 72400024 800345007 72400024 800345014 72400024 771029012 72400024 794405009 72400024 794405012 72400024 794405013 72400024 794405014 72400023 741419004 72400023 741419005 72400023 741419007 72400023 741419009 72400023 741419010 72400024 744211002 72400024 744211003 72400024 744211006 72400024 744211007 72400024 744211010 72400024 744211011 72400024 771029002 72400024 771029004 72400024 771029006 72400024 771029007 72400024 771029008 72400024 771029009 72400024 771029010 72400024 771029011 72400025 803589003 72400024 771029014 72400024 771029015 72400025 803589005 72400024 794405003 72400024 771029013 72400024 794405008 72400024 800345008 72400024 794405010 72400024 800345001 72400024 800345003 72400024 800345004 72400024 800345005 72400024 800345006 72400024 800345009 72400024 800345010 72400024 800345012 72400024 800345015 72400024 800345002
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
American Medical Systems, Inc.
Reason for Recall:
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

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.

Product Codes/Lot Numbers:

Model # Lot # 72400024 771029003 72400024 794405011 72400024 744211005 72400024 794405007 72400024 744211008 72400024 771029001 72400024 794405006 72400024 771029005 72400024 744211009 72400024 771029016 72400023 741419006 72400024 794405001 72400024 794405002 72400024 794405004 72400024 794405005 72400024 794405015 72400024 794405016 72400024 744211001 72400024 744211004 72400024 800345007 72400024 800345014 72400024 771029012 72400024 794405009 72400024 794405012 72400024 794405013 72400024 794405014 72400023 741419004 72400023 741419005 72400023 741419007 72400023 741419009 72400023 741419010 72400024 744211002 72400024 744211003 72400024 744211006 72400024 744211007 72400024 744211010 72400024 744211011 72400024 771029002 72400024 771029004 72400024 771029006 72400024 771029007 72400024 771029008 72400024 771029009 72400024 771029010 72400024 771029011 72400025 803589003 72400024 771029014 72400024 771029015 72400025 803589005 72400024 794405003 72400024 771029013 72400024 794405008 72400024 800345008 72400024 794405010 72400024 800345001 72400024 800345003 72400024 800345004 72400024 800345005 72400024 800345006 72400024 800345009 72400024 800345010 72400024 800345012 72400024 800345015 72400024 800345002

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1280-2013

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