# FDA recall Z-0488-2021

> **Coloplast Manufacturing US, LLC** · Class II · device recall initiated 2020-10-23.

## 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.

## 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.

## Key facts

- **Recall number:** Z-0488-2021
- **Recalling firm:** Coloplast Manufacturing US, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-10-23
- **Report date:** 2020-12-02
- **Termination date:** 2021-05-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0488-2021

## Citation

> AI Analytics. FDA recall Z-0488-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0488-2021. Source: US FDA. Licensed CC0.

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