Titan Inflatable Penile Prosthesis Pump Failure Risk Recall
Coloplast is recalling the Titan 0-Deg Infrapubic 20 Cm inflatable penile prosthesis due to reduced wall thickness in the pump that could cause premature failure. No injuries have been reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This Class II recall involves a medical implant with a manufacturing defect that creates potential for functional failure. While no injuries or adverse events have been reported, the risk-of-harm to an implanted surgical device warrants a High score per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Coloplast Manufacturing US, LLC is recalling the Titan 0-Deg Infrapubic 20 Cm inflatable penile prosthesis (Catalog Number ES88202400) with UDI/DI 05708932487245 and Lot Numbers 8849577 and 8849578. The device is a surgically implanted prosthesis used to treat erectile dysfunction.
The recall is due to a manufacturing defect in which some units have decreased wall thickness in the pump component. This reduced wall thickness creates the potential for premature pump failure, particularly over the course of repeated inflation and deflation cycles throughout the device's lifetime.
The affected devices were distributed worldwide, including throughout the United States, Turkey, Italy, Germany, Belgium, France, the United Kingdom, Spain, and Portugal. A total of 22 units are affected by this recall.
Patients who have received this implant should contact their physician to discuss whether their device is from one of the affected lot numbers. No adverse events or injuries related to this manufacturing defect have been reported to date.
The recalled product
- Product
- Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
- Manufacturer
- Coloplast Manufacturing US, LLC
- Hazard
- wall-thickness-defect
- pump-failure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- UDI/DI 05708932487245
- Lot Numbers: 8849577
- 8849578
Distribution
Distributed nationwide across the United States.
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