Inflatable Penile Prosthesis Recalled Due to Pump Failure Risk
Coloplast is recalling the Titan Touch NB Infr Zero 16cm inflatable penile prosthesis due to decreased wall thickness in the pump, which may cause premature failure with repeated use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall of a medical device with a structural defect that creates risk of premature pump failure. No illnesses or injuries have been reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, scoring as High (3).
Plain-English summary
Coloplast Manufacturing US, LLC is recalling the Titan Touch NB Infr Zero 16cm inflatable penile prosthesis (Catalog Number EN28162400, Lot Number 8887609).
The recalled devices contain decreased wall thickness in the pump mechanism. This defect creates a potential for premature pump failure with repeated inflation and deflation cycles during normal use.
The affected devices were distributed worldwide, including throughout the United States and internationally in Turkey, Italy, Germany, Belgium, France, the United Kingdom, Spain, and Portugal.
The recalled product
- Product
- Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
- Manufacturer
- Coloplast Manufacturing US, LLC
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 05708932072519
- Lot Numbers: 8887609
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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