Titan Pump — Class II medical device recall Z-0488-2021
Terminated recall by Coloplast Manufacturing US, LLC, reported 2020-12-02, distributed nationwide. Potential increased occurrence of pump fracture over the lifetime of the device.
| Recall number | Z-0488-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Coloplast Manufacturing US, LLC, Minneapolis, MN, United States |
| Recall initiated | 2020-10-23 |
| Classified | 2020-11-25 |
| Reported by FDA | 2020-12-02 |
| Terminated | 2021-05-13 |
| Distributed | Nationwide (US) |
| Quantity | 8,962 units |
| Reason classes | device malfunction |
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.
Reason for recall
Potential increased occurrence of pump fracture over the lifetime of the device.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0488-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.