Inflatable Penile Prosthesis Recalled for Potential Pump Failure Risk
Coloplast is recalling certain Titan NB Infra Zero Ang 16cm inflatable penile prostheses due to thinner-than-standard pump wall thickness that could lead to 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: FDA Class II recall for a medical device with a manufacturing defect that creates risk of functional failure. No illnesses or injuries are reported in the source material; the hazard is theoretical and relates to device performance rather than direct patient harm.
Plain-English summary
Coloplast Manufacturing US, LLC is recalling the Titan NB Infra Zero Ang 16cm inflatable penile prosthesis (Catalog Number EN88162400) due to a manufacturing defect affecting the pump wall thickness.
The affected prostheses have decreased wall thickness in the pump compared to the standard design. This thinner wall has the potential to result in premature pump failure based on the number of times the prosthesis is inflated and deflated during normal use.
The recalled devices have been distributed worldwide, including throughout the United States and in Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, and Portugal. The affected lot numbers are 8887620 and 8939124, with UDI/DI 05708932072595.
Patients who have received this prosthesis should contact their healthcare provider or Coloplast directly to discuss their options, which may include replacement or inspection of the device.
The recalled product
- Product
- Titan NB Infra Zero Ang 16cm, Catalog Number EN88162400; inflatable penile Prosthesis
- Manufacturer
- Coloplast Manufacturing US, LLC
- Affected units
- 2
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 (3)
- UDI/DI 05708932072595
- Lot Numbers: 8887620
- 8939124
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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