{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Minnetonka", "state": "MN", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "64875", "recalling_firm": "American Medical Systems, Inc.", "address_1": "10700 Bren Rd W", "address_2": "", "postal_code": "55343-9679", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "Worldwide Distribution -- Nationwide Distribution including the states of AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY,NC, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VT, VA, WA and WI., and the countries of AUSTRIA, AUSTRALIA, CANADA, BELGIUM, SWITZERLAND, CZECH REPUBLIC, GERMANY, DENMARK, ESTONIA, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, IRELAND, ITALY, LEBANON, NETHERLANDS, NORWAY, SWEDEN, TURKEY, ARGENTINA, BRAZIL, IVORY COST, COLOMBIA, ECUADOR, INDIA, JAPAN, MEXICO, NEW ZEALAND, PANAMA and VENEZUELA.", "recall_number": "Z-1279-2013", "product_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_quantity": "605", "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.", "recall_initiation_date": "20130301", "center_classification_date": "20130510", "termination_date": "20140424", "report_date": "20130522", "code_info": "Model # Lot # 720172-01 737875001 720172-01 737875002 720172-01 737875003 720172-01 737875004 72400098 714613001 72400098 714613002 72400098 714613003 72400098 714613004 72400098 714613005 72400098 714613006 72400098 714613007 72400098 714613008 72400098 714613009 72400098 714613010 72400098 714613011 72400098 714613013 72400098 714613014 72400098 714613015 72400098 714631001 72400098 714631002 72400098 714631003 72400098 714631004 72400098 714631005 72400098 714631006 72400098 714631007 72400098 714631008 72400098 714631009 72400098 714631010 72404127 786981017 72400098 714631014 72400098 714631015 72400098 714631016 72400098 714631017 72400098 714631018 72400098 714631019 72400098 714631020 72400098 714644001 72400098 714644002 72400098 714644003 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