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U.S. Department of Health and Human Services

Class 2 Device Recall AMS 800 Urinary Control System

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  Class 2 Device Recall AMS 800 Urinary Control System see related information
Date Initiated by Firm March 01, 2013
Date Posted May 10, 2013
Recall Status1 Terminated 3 on April 24, 2014
Recall Number Z-1280-2013
Recall Event ID 64875
PMA Number P000053 
Product Classification Device, incontinence, mechanical/hydraulic - Product Code EZY
Product 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.




Code Information 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 
Recalling Firm/
Manufacturer		 American Medical Systems, Inc.
10700 Bren Rd W
Minnetonka MN 55343-9679
For Additional Information Contact
952-930-6000
Manufacturer 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.
FDA Determined
Cause 2		 Release of Material/Component prior to receiving test results
Action American Medical Systems sent two written communications distributed within the United States. The first is a letter that is being delivered to customers who purchased the affected lots using their ship to address from the original sales order. The second is a letter being delivered to implanting physician customers who are known by AMS to be regular users of the devices. Similar letters will be sent to international customers, including both end users and distributors (where applicable). American Medical Systems sent a "Urgent Medical Device Recall" letter dated February 28, 2013, to all affected customers. The letters identified the product, the problem, and the action needed to be taken by the customer. Customers were instructed to return the recalled product and to complete the Product Recall Acknowledgement Form. The letters addressed to "Physicians" advised consignees against prophylactic removal of implanted control pumps and pressure-regulating balloons contained within the scope of the product recall. For further questions please call AMS Customer Service at 1 (800) 328-3881
Quantity in Commerce 77
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = EZY and Original Applicant = Boston Scientific Corp.
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