Inflatable Penile Prosthesis Risk of Premature Pump Failure
Coloplast's Titan Touch NB Scrot Zero 16cm prosthesis has been recalled due to decreased wall thickness that could cause premature pump failure. The defect was identified in specific lot units distributed worldwide.
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 medical device recall with a potential mechanical defect (decreased wall thickness creating risk of premature pump failure). No illnesses or injuries have been reported in the source, making the hazard theoretical rather than confirmed, which places this at the High level of the rubric.
Plain-English summary
Coloplast Manufacturing US, LLC is recalling the Titan Touch NB Scrot Zero 16cm (Catalog Number EN29162400), an inflatable penile prosthesis due to decreased wall thickness in the pump mechanism.
The product has decreased wall thickness compared to units with standard wall thickness. This creates a potential for premature pump failure based on the number of inflation and deflation cycles the device undergoes.
The affected lot is Lot Number 8840684. The device has been distributed worldwide, including throughout the United States and in Turkey, Italy, Germany, Belgium, France, the United Kingdom, Spain, and Portugal.
Patients who have this device should consult with their healthcare provider regarding this recall.
The recalled product
- Product
- Titan Touch NB Scrot Zero 16cm, Catalog Number EN29162400; inflatable penile Prosthesis
- Manufacturer
- Coloplast Manufacturing US, LLC
- Category
- Medical Device
- Hazard
- 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 (2)
- UDI/DI 05708932072557
- Lot Numbers: 8840684
Distribution
Distributed nationwide across the United States.
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