Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Titan Pump - Product Usage: indicated for male patients suffering Recalled by Coloplast Manufacturing US, LLC Due to Potential increased occurrence of pump fracture over the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Coloplast Manufacturing US, LLC directly.
Affected Products
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.
Quantity: 8,962 units
Why Was This Recalled?
Potential increased occurrence of pump fracture over the lifetime of the device.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Coloplast Manufacturing US, LLC
Coloplast Manufacturing US, LLC has 28 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report