Class 2 Device Recall Titan Pump

• Date Initiated by Firm: October 23, 2020
• Create Date: November 25, 2020
• Recall Status: Terminated 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: 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.