The Recall Desk
HighFDA (Devices)·Z-1364-2023·Announced 2023-04-19

Inflatable Penile Prosthesis Recalled for Premature Pump Failure Risk

Coloplast is recalling 13 units of the Titan Touch NB Scrot Zero 18cm inflatable penile prosthesis due to decreased wall thickness that could cause 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: This is a Class II recall with a theoretical risk of device malfunction; no illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High.

Plain-English summary

Coloplast Manufacturing US, LLC is recalling the Titan Touch NB Scrot Zero 18cm inflatable penile prosthesis (Catalog Number EN29182400). The recall involves 13 units.

The recalled units have decreased wall thickness in the pump. This structural defect has the potential for premature pump failure based on the number of interactions required to inflate and deflate the prosthesis.

The affected products were distributed worldwide, including throughout the United States and internationally to Turkey, Italy, Germany, Belgium, France, the United Kingdom, Spain, and Portugal. The affected lot numbers are 8829594, 8849571, 8806760, and 8840685.

The recalled product

Product
Titan Touch NB Scrot Zero 18cm, Catalog Number EN29182400; inflatable penile Prosthesis
Manufacturer
Coloplast Manufacturing US, LLC
Category
Medical Device — Penile Prosthesis
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 (5)

  • UDI/DI 05708932072564
  • Lot Numbers: 8829594
  • 8849571
  • 8806760
  • 8840685

Distribution

Distributed nationwide across the United States.

Related recalls

Same category