Recall Z-1280-2013— American Medical Systems, Inc.

Class II FDA medical device recall by American Medical Systems, Inc., initiated 2013-03-01, terminated 2014-04-24. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..

Recalling firm

American Medical Systems, Inc.

Classification

Class II

Status

Terminated

Initiated

2013-03-01

Terminated

2014-04-24

Firm location

Minnetonka, MN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.