Titan Touch Pump Inflatable Prosthesis Recalled for Structural Defect Risk
Coloplast Manufacturing is recalling Titan Touch Pump inflatable penile prostheses due to manufacturing defect causing decreased wall thickness that could lead to premature device 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: This is a risk-of-harm medical device recall involving an implanted prosthesis. The manufacturing defect (decreased wall thickness) creates potential for premature device failure. While no injuries have been reported, the specific structural defect presents a clear risk of harm to patients, consistent with FDA Class II classification criteria.
Plain-English summary
Coloplast Manufacturing US, LLC is recalling Titan Touch Pump inflatable penile prostheses (Catalog Number 5177502400) due to a manufacturing defect affecting the pump's wall thickness.
The pump's decreased wall thickness could lead to premature device failure compared to pumps with standard wall thickness, particularly based on the number of times the prosthesis is inflated and deflated. No injuries have been reported.
The recall affects 18 units with the following lot numbers: 8849559, 8849560, 8849623, 8887867, 8849624, 8497256, and 8904186. The devices were distributed worldwide, including in the United States, Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, and Portugal.
Patients with this device should contact their healthcare provider or Coloplast Manufacturing for guidance regarding their device.
The recalled product
- Product
- Titan Touch Pump, Catalog Numbers 5177502400; inflatable penile Prosthesis
- Manufacturer
- Coloplast Manufacturing US, LLC
- Hazard
- device-failure
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 (8)
- UDI/DI 05708932533966
- Lot Numbers: 8849559
- 8849560
- 8849623
- 8887867
- 8849624
- 8497256
- 8904186
Distribution
Distributed nationwide across the United States.
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