Z-0488-2021Class II

Titan Pump -

Name: Z-0488-2021 Titan Pump -
Creator: Coloplast Manufacturing US, LLC
Published: 2020-10-23
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2020-10-23 / Terminated / root cause: design

FDA source

Coloplast Manufacturing US, LLC began a recall of Titan Pump - Product Usage: indicated for male patients suffering from erectile dysfunction (impotence) who are considered to be candidates for implantation of... on 2020-10-23. FDA classified it as Class II and gives the reason as "Potential increased occurrence of pump fracture over the lifetime of the device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0488-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-23
Posted: 2020-11-25
Terminated: 2021-05-13
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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 Device, Impotence, Mechanical/Hydraulic
Reason for recall: Potential increased occurrence of pump fracture over the lifetime of the device.
Root cause tag: design
FDA 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 [email protected].
Quantity in commerce: 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.
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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0488-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0488-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-02	2020-11-25

Product code FHW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)