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: 25 units Lot/code info: UDI/DI 05708932487344, Lot Numbers: 8849599, 8887865, 8939119, 8904178, 8904179
05708932487344
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.