Inflatable Penile Prosthesis Recalled Due to Risk of Premature Pump Failure
Coloplast is recalling Titan Touch Scro Zero Ang 20cm penile prostheses due to decreased wall thickness that could cause premature pump failure. Patients should contact their healthcare provider for guidance.
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 is an FDA Class II recall of a medical device with potential for functional failure due to material defect. Although no injuries or device failures have been reported, the risk of premature pump failure during normal use qualifies this as a risk-of-harm device recall.
Plain-English summary
Coloplast Manufacturing US, LLC is recalling the Titan Touch Scro Zero Ang 20cm inflatable penile prosthesis (Catalog Number ES29202400, Lot Numbers 8904188, 8806754, 8806755). This medical device is designed to inflate and deflate to restore penile function.
The recalled devices have decreased wall thickness in the pump mechanism. This reduced thickness creates a risk of premature pump failure compared to prostheses with standard wall thickness, particularly based on repeated inflation and deflation during normal use.
The affected prostheses were distributed worldwide, including throughout the United States and internationally in Turkey, Italy, Germany, Belgium, France, the United Kingdom, Spain, and Portugal.
Patients who have received this prosthesis should contact their healthcare provider or Coloplast Manufacturing US, LLC for further instructions and guidance on available options.
The recalled product
- Product
- Titan Touch Scro Zero Ang 20cm, Catalog Number ES29202400; inflatable penile Prosthesis
- Manufacturer
- Coloplast Manufacturing US, LLC
- Hazard
- pump-failure
- material-defect
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 (4)
- UDI/DI 05708932539197
- Lot Numbers: 8904188
- 8806754
- 8806755
Distribution
Distributed nationwide across the United States.
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