The Recall Desk
HighFDA (Devices)·Z-1372-2023·Announced 2023-04-19

Titan Inflatable Penile Prosthesis Pump Failure Risk Recall

Coloplast is recalling the Titan 0-Deg Infrapubic 20 Cm inflatable penile prosthesis due to reduced wall thickness in the pump that could cause premature failure. No injuries have been reported.

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 Class II recall involves a medical implant with a manufacturing defect that creates potential for functional failure. While no injuries or adverse events have been reported, the risk-of-harm to an implanted surgical device warrants a High score per the rubric criterion for risk-of-harm products without reported injury.

Plain-English summary

Coloplast Manufacturing US, LLC is recalling the Titan 0-Deg Infrapubic 20 Cm inflatable penile prosthesis (Catalog Number ES88202400) with UDI/DI 05708932487245 and Lot Numbers 8849577 and 8849578. The device is a surgically implanted prosthesis used to treat erectile dysfunction.

The recall is due to a manufacturing defect in which some units have decreased wall thickness in the pump component. This reduced wall thickness creates the potential for premature pump failure, particularly over the course of repeated inflation and deflation cycles throughout the device's lifetime.

The affected devices were distributed worldwide, including throughout the United States, Turkey, Italy, Germany, Belgium, France, the United Kingdom, Spain, and Portugal. A total of 22 units are affected by this recall.

Patients who have received this implant should contact their physician to discuss whether their device is from one of the affected lot numbers. No adverse events or injuries related to this manufacturing defect have been reported to date.

The recalled product

Product
Titan 0-Deg Infrapubic 20 Cm, Catalog Number ES88202400; inflatable penile Prosthesis
Manufacturer
Coloplast Manufacturing US, LLC
Category
Medical Device — Penile Prosthesis
Hazard
Affected units
22

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 05708932487245
  • Lot Numbers: 8849577
  • 8849578

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 · wall thickness defect

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