American Medical Systems Recalls AMS 800 Urinary Control System Components
American Medical Systems is recalling 605 AMS 800 Urinary Control System pumps and balloons released without meeting final product criteria.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
American Medical Systems, Inc. is recalling 605 units of the AMS 800 Urinary Control System, specifically the Control Pump and Pressure-Regulating Balloon components. The recall was initiated because these products were released despite not meeting all final product release criteria.
The AMS 800 Urinary Control System is an implantable, fluid-filled, solid silicone elastomer device used to treat urinary incontinence due to reduced outlet resistance following prostate surgery. The affected components are part of a system that includes a cuff, a pump, and a pressure-regulating balloon connected by tubing.
The affected units were distributed worldwide, including nationwide distribution across numerous U.S. states and territories, as well as in countries across Europe, Asia, South America, and Oceania. Patients with implanted AMS 800 systems should contact their healthcare provider for guidance regarding the recall.
The recalled product
- 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
- Manufacturer
- American Medical Systems, Inc.
- Hazard
- Affected units
- 605
Distribution
Part of a larger recall action
This product is one of 2 recalled by American Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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