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Coloplast Manufacturing US, LLC recalls Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are consider
Recalled December 2, 2020 · FDA recall Z-0488-2021 · Coloplast Manufacturing US
Hazard
Potential increased occurrence of pump fracture over the lifetime of the device. · FDA Class II
Units
8,962 units
Sold at
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.
Description
Potential increased occurrence of pump fracture over the lifetime of the 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.
Manufacturer(s)
Coloplast Manufacturing US, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →