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Recall Observatory FDA recall evidence

Device 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.

Z-0488-2021

October 23, 2020

Class II

Product summary

Firm
Coloplast Manufacturing US, LLC
Event
Event 86618
Status
Terminated
Classification
Class II
Quantity
8,962 units
Official record key
device-enforcement:Z-0488-2021

Official wording

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

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Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of DK, ES, JP.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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