AMS 800¿ Urinary Control System — Class II medical device recall Z-1280-2013
Terminated recall by American Medical Systems, Inc., reported 2013-05-22, distributed nationwide. American Medical Systems, Inc. is initiating a recall on two components of the AMS 800¿ Urinary Control System
| Recall number | Z-1280-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | American Medical Systems, Inc., Minnetonka, MN, United States |
| Recall initiated | 2013-03-01 |
| Classified | 2013-05-10 |
| Reported by FDA | 2013-05-22 |
| Terminated | 2014-04-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CH, CO, CZ, DE, DK, EC, EE, ES, FI, FR, GB, IE, IN, IT, JP, LB, MX, NL, NO, NZ, PA, SE, TR, VE |
| Quantity | 77 |
| Lot numbers | 72400023, 72400024, 72400025, 741419004, 741419005, 741419006, 741419007, 741419009, 741419010, 744211001, 744211002, 744211003, 744211004, 744211005, 744211006, 744211007, 744211008, 744211009, 744211010, 744211011, 771029001, 771029002, 771029003, 771029004, 771029005, 771029006, 771029007, 771029008, 771029009, 771029010, 771029011, 771029012, 771029013, 771029014, 771029015, 771029016, 794405001, 794405002, 794405003, 794405004 and 27 more |
| Model numbers | 72400023, 72400024, 72400025, 741419004, 741419005, 741419006, 741419007, 741419009, 741419010, 744211001, 744211002, 744211003, 744211004, 744211005, 744211006, 744211007, 744211008, 744211009, 744211010, 744211011, 771029001, 771029002, 771029003, 771029004, 771029005 and 42 more |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1280-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.