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U.S. Department of Health and Human Services

Class 2 Device Recall Titan Pump

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  Class 2 Device Recall Titan Pump see related information
Date Initiated by Firm October 23, 2020
Create Date November 25, 2020
Recall Status1 Terminated 3 on May 13, 2021
Recall Number Z-0488-2021
Recall Event ID 86618
Product Classification Device, impotence, mechanical/hydraulic - Product Code FHW
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.
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Recalling Firm/
Manufacturer		 Coloplast Manufacturing US, LLC
1601 W River Rd
Minneapolis MN 55411-3431
For Additional Information Contact Diane Brinza
800-788-0293
Manufacturer Reason
for Recall		 Potential increased occurrence of pump fracture over the lifetime of the device.
FDA Determined
Cause 2		 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 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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