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.
Enforcement
- Recall Number
- Z-0488-2021
- Event ID
- 86618
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Coloplast Manufacturing US, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 2, 2020
- Initiation Date
- October 23, 2020
- Classification Date
- November 25, 2020
- Termination Date
- May 13, 2021
- Address
- 1601 W River Rd, N/A, Minneapolis, MN, 55411-3431, United States
Description
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.
Potential increased occurrence of pump fracture over the lifetime of the device.
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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.
8,962 units