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.
Reported: December 2, 2020 Initiated: October 23, 2020 #Z-0488-2021
Product 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.
Reason for Recall
Potential increased occurrence of pump fracture over the lifetime of the device.
Details
- Recalling Firm
- Coloplast Manufacturing US, LLC
- Units Affected
- 8,962 units
- Distribution
- 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.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Coloplast Manufacturing US, LLC. Units affected: 8,962 units.
Why was this product recalled? ▼
Potential increased occurrence of pump fracture over the lifetime of the device.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 2, 2020. Severity: Moderate. Recall number: Z-0488-2021.
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