Inflatable Penile Prosthesis Pump Risk of Premature Failure
Coloplast is recalling Titan Touch NB Infr Zero 18cm inflatable penile prostheses due to decreased pump wall thickness that may cause premature device failure after repeated use.
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: FDA Class II recall of a medical device with a confirmed structural defect (thin pump walls) that creates risk of functional failure during normal use. No illnesses or injuries have been reported, but the defect poses a risk of harm to users.
Plain-English summary
Coloplast Manufacturing US, LLC is recalling the Titan Touch NB Infr Zero 18cm inflatable penile prosthesis (Catalog Number EN28182400). Seven units with Lot Numbers 8849570, 8904168, and 8939114 are affected.
The pump component in these devices has decreased wall thickness compared to standard specifications. This structural weakness has the potential to cause premature pump failure based on the number of inflate and deflate cycles during normal use.
The affected devices were distributed worldwide, including throughout the United States and to Turkey, Italy, Germany, Belgium, France, the United Kingdom, Spain, and Portugal. Patients and healthcare providers with this device should contact Coloplast Manufacturing US, LLC for information about the recall and appropriate remedial actions.
The recalled product
- Product
- Titan Touch NB Infr Zero 18cm, Catalog Number EN28182400; inflatable penile Prosthesis
- Manufacturer
- Coloplast Manufacturing US, LLC
- Hazard
- device-defect
- premature-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 (4)
- UDI/DI 05708932072526
- Lot Numbers: 8849570
- 8904168
- 8939114
Distribution
Distributed nationwide across the United States.
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