medical Class II Updated 2020-12-02

Coloplast Manufacturing US, LLC recalls Titan Pump - Product Usage: indicated for male patients suff

Recalled Product

Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of a penile prosthesis.


Hazard / Issue

Potential increased occurrence of pump fracture over the lifetime of the device.

Issued by

FDA

Distribution: Nationwide (United States)
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