Titan Penile Prosthesis Recalled Due to Premature Pump Failure Risk
Coloplast Manufacturing is recalling the Titan 0-Deg Scrotal 18 Cm inflatable penile prosthesis (25 units) due to decreased wall thickness that may cause premature pump failure. Patients with affected lot numbers should contact their healthcare provider.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with a manufacturing defect but no reported illnesses, injuries, or deaths. The hazard is functional device failure rather than direct risk of bodily harm, warranting a Moderate severity rating.
Plain-English summary
Coloplast Manufacturing US, LLC is recalling the Titan 0-Deg Scrotal 18 Cm inflatable penile prosthesis (Catalog Number ES89182400, UDI/DI 05708932487344). The recall involves 25 units distributed worldwide to the United States, Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, and Portugal. Affected lot numbers are 8849599, 8887865, 8939119, 8904178, and 8904179.
The recall is due to a manufacturing defect involving decreased wall thickness in the device's pump mechanism. This reduced wall thickness has the potential to cause the pump to fail prematurely compared to a device with standard wall thickness. The risk increases with repeated inflation and deflation cycles during normal use of the prosthesis.
Patients who have received this device should check whether they have one of the affected lot numbers by contacting their healthcare provider or the manufacturer. Patients with affected devices should seek advice from their healthcare provider regarding appropriate management options, which may include device replacement or surgical removal.
The recalled product
- Product
- Titan 0-Deg Scrotal 18 Cm, Catalog Number ES89182400; 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 (6)
- UDI/DI 05708932487344
- Lot Numbers: 8849599
- 8887865
- 8939119
- 8904178
- 8904179
Distribution
Distributed nationwide across the United States.
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