Inflatable Penile Prosthesis Recalled for Potential Pump Failure Risk
Coloplast is recalling 15 units of the Titan Touch Infr Zero Ang inflatable penile prosthesis (Lot Numbers 8849582, 8849603, 8904185) worldwide due to decreased wall thickness that may cause premature pump failure.
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 medical device recall involves a structural defect (decreased wall thickness) with potential for device malfunction. No injuries, hospitalizations, or actual failures have been reported. The hazard is theoretical, making this a High-severity (3) risk-of-harm product per FDA classification guidelines.
Plain-English summary
Coloplast Manufacturing US, LLC is recalling 15 units of the Titan Touch Infr Zero Ang 18cm inflatable penile prosthesis (Catalog Number ES28182400) due to a manufacturing defect affecting wall thickness. A decrease in wall thickness has the potential for premature pump failure compared to devices with standard wall thickness, particularly after repeated use to inflate and deflate the prosthesis.
The affected units are identified by UDI/DI 05708932539128 and Lot Numbers 8849582, 8849603, or 8904185. These devices were distributed worldwide, including throughout the United States, Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, and Portugal.
Patients implanted with this device who experience any difficulty with pump operation should contact their healthcare provider. Additional information about this recall is available from the FDA.
The recalled product
- Product
- Titan Touch Infr Zero Ang 18cm, Catalog Number ES28182400; inflatable penile Prosthesis
- Manufacturer
- Coloplast Manufacturing US, LLC
- Hazard
- pump-failure
- structural-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 05708932539128
- Lot Numbers: 8849582
- 8849603
- 8904185
Distribution
Distributed nationwide across the United States.
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