A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
Reason for recall: A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis. Distribution: Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal. Quantity: 13 units Lot/code info: UDI/DI 05708932072564, Lot Numbers: 8829594, 8849571, 8806760, 8840685
05708932072564
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.