FDAOctober 23, 2020device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

coloplast manufacturingcoloplast

UPCs

73380387348370

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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