Recall Z-0488-2021 ยท FHW Device, Impotence, Mechanical/Hydraulic
Coloplast Manufacturing US, LLC
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.
| Date | Oct 23, 2020 |
| Status | Terminated |
| Reason | Potential increased occurrence of pump fracture over the lifetime of the device. |
| Root cause | Component design/selection |
| Action | Required Action Coloplast asks that you please do the following: 1. Immediately move all inventory (purchased directly or that may be stocked as consignment inventory) to quarantine, and return all Titan pump product (as identified in this notification) to Coloplast within 10 business days of receiving this letter. Product return instructions are located at the end of the attached Acknowledgement and Receipt Form. If you have further distributed this product, please notify your customers at once of this recall. 2. Complete the attached Acknowledgement and Receipt Form indicating the quantity t |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.