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Recall Observatory FDA recall evidence

Device product

Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis

Z-1372-2023

March 01, 2023

Class II

Product summary

Firm
Coloplast Manufacturing US, LLC
Event
Event 91800
Status
Ongoing
Classification
Class II
Quantity
22 units
Official record key
device-enforcement:Z-1372-2023

Official wording

Reason: 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.

Code information: UDI/DI 05708932487245, Lot Numbers: 8849577, 8849578

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, Portugal.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.