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.
Recall
- Recall Number
- Z-1279-2013
- Event Number
- 64875
- Firm
- American Medical Systems, Inc.
- FEI Number
- 1000116179
- Product Code
- EZY
- Status
- Terminated
- Root Cause
- Release of Material/Component prior to receiving test results
- Initiated
- March 1, 2013
- Posted
- May 10, 2013
- Terminated
- April 24, 2014
- Address
- 10700 Bren Rd, W Minnetonka, MN, 55343-9679
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.
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.
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
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.
605