AMS 800 Urinary Control System Components Recalled for Release Criteria Failures
American Medical Systems is recalling 77 AMS 800 Control Pumps and Pressure-Regulating Balloons because they were released without meeting final product release criteria.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 voluntary precautionary recall.
Plain-English summary
American Medical Systems, Inc. is recalling 77 units of two components of the AMS 800 Urinary Control System: the Control Pump and the Pressure-Regulating Balloon. The AMS 800 system is an implantable device used to treat urinary incontinence following prostate surgery. The specific components being recalled were released despite not meeting all final product release criteria.
The affected units were distributed worldwide, including nationwide distribution in the United States and in numerous countries across Europe, the Americas, Asia, and the Middle East. The recall covers specific model and lot numbers listed in the official FDA record.
Patients who have had the AMS 800 system implanted should contact their healthcare provider or American Medical Systems for further instructions regarding the recall and potential replacement or repair of the affected components.
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
- 77
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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