Device recall
Z-0488-2021: Titan Pump - Product Usage: indicated for male patients suffering from erectile…
FDA device recall · Class II · Coloplast Manufacturing US, LLC
Key facts
| Recall number (Z-number) | Z-0488-2021 |
|---|---|
| Recall event | 86618 |
| 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. |
| Product code | FHW |
| Recalling firm | Coloplast Manufacturing US, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 13, 2021 |
| FEI number | 2125050 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database