Inflatable Prosthesis Pump Assembly Recalled for Premature Failure Risk
Coloplast is recalling 9 Titan Pump Assemblies for inflatable penile prostheses due to decreased wall thickness that may cause premature pump failure during normal 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: This is a risk-of-harm product (structural defect in an implanted medical device that could result in device failure) where no injuries or malfunctions have been reported. The hazard is theoretical based on potential failure from repeated use, meeting the criterion for Score 3.
Plain-English summary
Coloplast Manufacturing US, LLC is recalling 9 Titan Pump Assemblies (Catalog Number 5177701400) used in inflatable penile prostheses. The recall involves Lot Numbers 8904177 and 8849617.
The affected pump assemblies have decreased wall thickness that has the potential to cause premature pump failure compared to pumps with standard wall thickness. The potential for failure depends on the number of times the device is inflated and deflated.
These units were distributed worldwide to the United States and to Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, and Portugal.
If you have received one of these prostheses, contact Coloplast Manufacturing US, LLC or your healthcare provider immediately regarding replacement options and what actions you should take.
The recalled product
- Product
- Titan Pump Assembly, Catalog Number 5177701400; inflatable penile Prosthesis
- Manufacturer
- Coloplast Manufacturing US, LLC
- Hazard
- pump-failure
- structural-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 (3)
- UDI/DI 05708932319621
- Lot Numbers: 8904177
- 8849617
Distribution
Distributed nationwide across the United States.
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