FDA Device recall Z-1279-2013
AMS 800¿ Urinary Control System
- FDA Device
- Class II
- terminated
- Published 2013-05-22
On 2013-05-22 the FDA classified a Class II recall of AMS 800¿ Urinary Control System by American Medical Systems, citing 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 rel….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1279-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-01 |
| Published | 2013-05-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | American Medical Systems |
| Distribution | US |
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.
Identifiers
| code_info | Model # Lot # 720172-01 737875001 720172-01 737875002 720172-01 737875003 720172-01 737875004 72400098 714…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 72400098 714644004 72400098 714644005 72400098 714644007 72400098 714644008 72400098 714644009 72400098 714644010 72400098 714644011 72400098 714644012 72400098 714644013 72400098 7146 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1279-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.