Reported May 22, 2013 · Terminated
AMS 800¿ Urinary Control System. The AMS 800¿ Urinary Control System is used to treat urinary incontinence due to…
American Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Medical Systems, Inc. · 10700 Bren Rd W · Minnetonka, MN · 55343-9679
Is this the product you have?
- 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 componentsa 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
- Lot codes and dates
- Model # Lot #
3,258 of 3,258 codes
720172-01737875001720172-01737875002720172-01737875003720172-017378750047240009871461300172400098714613002724000987146130037240009871461300472400098714613005724000987146130067240009871461300772400098714613008724000987146130097240009871461301072400098714613011724000987146130137240009871461301472400098714613015724000987146310017240009871463100272400098714631003724000987146310047240009871463100572400098714631006724000987146310077240009871463100872400098714631009724000987146310107240412778698101772400098714631014
- Model # Lot #
- Amount recalled
- 605
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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