The Recall Desk
HighFDA (Devices)·Z-1368-2023·Announced 2023-04-19

Inflatable Penile Prosthesis Recalled for Risk of Premature Pump Failure

Coloplast is recalling Titan Touch inflatable penile prostheses with reduced pump wall thickness, which could cause premature failure during use. The defect affects 8 units distributed across the US and multiple European countries.

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 medical device recall with a manufacturing defect (wall thickness reduction) that creates risk of premature pump failure, but no hospitalizations or injuries have been reported. Per the rubric, theoretical hazards without reported injury in risk-of-harm products score at most 3.

Plain-English summary

Coloplast Manufacturing US, LLC is recalling the Titan Touch Infr Zero Ang 22cm inflatable penile prosthesis (Catalog Number ES28222400) due to a manufacturing defect affecting wall thickness.

The recalled units have decreased wall thickness in the pump compared to the standard specification. This defect has the potential to cause premature pump failure, particularly as the device is used repeatedly for inflation and deflation cycles.

Affected users should stop using the device and contact their healthcare provider. The recall involves 8 units (Lot Numbers 8849563, 8849585, 8904187) distributed worldwide, including the US, Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, and Portugal.

Users experiencing device failure or other complications should consult their physician. Customers may contact Coloplast Manufacturing US, LLC for further information about the recall and replacement options.

The recalled product

Product
Titan Touch Infr Zero Ang 22cm, Catalog Number ES28222400; inflatable penile Prosthesis
Manufacturer
Coloplast Manufacturing US, LLC
Category
Medical Device — Prosthetic Device
Hazard
Affected units
8

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 (4)

  • UDI/DI 05708932539142
  • Lot Numbers: 8849563
  • 8849585
  • 8904187

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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