The Recall Desk
HighFDA (Devices)·Z-1361-2023·Announced 2023-04-19

Inflatable Penile Prosthesis Recalled Due to Pump Failure Risk

Coloplast is recalling the Titan Touch NB Infr Zero 16cm inflatable penile prosthesis due to decreased wall thickness in the pump, which may cause premature failure with repeated 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 an FDA Class II recall of a medical device with a structural defect that creates risk of premature pump failure. No illnesses or injuries have been reported. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, scoring as High (3).

Plain-English summary

Coloplast Manufacturing US, LLC is recalling the Titan Touch NB Infr Zero 16cm inflatable penile prosthesis (Catalog Number EN28162400, Lot Number 8887609).

The recalled devices contain decreased wall thickness in the pump mechanism. This defect creates a potential for premature pump failure with repeated inflation and deflation cycles during normal use.

The affected devices were distributed worldwide, including throughout the United States and internationally in Turkey, Italy, Germany, Belgium, France, the United Kingdom, Spain, and Portugal.

The recalled product

Product
Titan Touch NB Infr Zero 16cm, Catalog Number EN28162400; inflatable penile Prosthesis
Manufacturer
Coloplast Manufacturing US, LLC
Category
Medical Device — Prosthesis / Implant
Hazard

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 (2)

  • UDI/DI 05708932072519
  • Lot Numbers: 8887609

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.

See all 17 products in this recall →

Related recalls

Same manufacturer · Coloplast Manufacturing US, LLC

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Same hazard · structural defect

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