Inflatable Penile Prosthesis Recalled for Premature Pump Failure Risk
Coloplast is recalling Titan Touch Scro Zero Ang 16cm prostheses (Lot 8840677) due to decreased wall thickness that may cause premature pump failure. Affected devices were distributed worldwide, including throughout the US.
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 for a manufacturing defect creating risk of device failure. No illnesses or injuries reported, making this a theoretical risk-of-harm scenario where a defective medical device could fail during use without established harm history.
Plain-English summary
Coloplast Manufacturing US, LLC is recalling the Titan Touch Scro Zero Ang 16cm inflatable penile prosthesis (Catalog Number ES29162400, UDI/DI 05708932539173) due to a manufacturing defect. Affected units with Lot Number 8840677 have decreased wall thickness compared to devices manufactured to specification. This reduction in wall thickness creates a potential for premature pump failure based on the number of inflate and deflate cycles performed during normal use.
The affected devices were distributed worldwide, including throughout the United States and in Turkey, Italy, Germany, Belgium, France, the United Kingdom, Spain, and Portugal.
Users of the affected prosthesis should contact Coloplast Manufacturing US, LLC or consult their healthcare provider to discuss the risk and any appropriate next steps. The FDA encourages anyone who has experienced a problem with this device to report it through the MedWatch program.
The recalled product
- Product
- Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
- Manufacturer
- Coloplast Manufacturing US, LLC
- Hazard
- pump-failure
- manufacturing-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 (2)
- UDI/DI 05708932539173
- Lot Numbers: 8840677
Distribution
Distributed nationwide across the United States.
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