Inflatable Penile Prosthesis Recalled for Premature Pump Failure Risk
Coloplast is recalling 13 units of the Titan Touch NB Scrot Zero 18cm inflatable penile prosthesis due to decreased wall thickness that could 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 is a Class II recall with a theoretical risk of device malfunction; no illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High.
Plain-English summary
Coloplast Manufacturing US, LLC is recalling the Titan Touch NB Scrot Zero 18cm inflatable penile prosthesis (Catalog Number EN29182400). The recall involves 13 units.
The recalled units have decreased wall thickness in the pump. This structural defect has the potential for premature pump failure based on the number of interactions required to inflate and deflate the prosthesis.
The affected products were distributed worldwide, including throughout the United States and internationally to Turkey, Italy, Germany, Belgium, France, the United Kingdom, Spain, and Portugal. The affected lot numbers are 8829594, 8849571, 8806760, and 8840685.
The recalled product
- Product
- Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
- Manufacturer
- Coloplast Manufacturing US, LLC
- Affected units
- 13
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 (5)
- UDI/DI 05708932072564
- Lot Numbers: 8829594
- 8849571
- 8806760
- 8840685
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Coloplast Manufacturing US, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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