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.

Recall number

Z-0488-2021

Recalling firm

Coloplast Manufacturing US, LLC

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.

Status

Terminated

Initiated

2020-10-23

Posted

not on file

Terminated

2021-05-13

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 that will be returned. If you do not have pumps to return, please denote that on the form. Please ensure you fill in your contact information. 3. Forward the completed form to the Coloplast contact information found at the bottom of the acknowledgement form. If you have further questions, please contact the Coloplast Customer Service team directly at (800) 258-3476, or by email urology@coloplast.com.

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.

Lot, serial or model codes

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510(k) numbers

not on file

PMA numbers

not on file

Product code

FHW

Firm FEI

2125050

Firm city

Minneapolis

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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