The Recall Desk
HighFDA (Devices)·Z-1371-2023·Announced 2023-04-19

Inflatable Penile Prosthesis Recall Due to Potential Pump Failure Risk

Coloplast is recalling certain inflatable penile prostheses due to decreased wall thickness that may cause premature pump 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 is an FDA Class II recall involving a structural defect (decreased wall thickness) that poses a risk of device failure. No injuries, illnesses, or actual failures have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as 'High' (score 3).

Plain-English summary

Coloplast Manufacturing US, LLC is recalling certain Titan Touch Scro Zero Ang 22cm inflatable penile prostheses (Catalog Number ES29222400) due to decreased wall thickness in the pump component.

The thinner pump wall has the potential to fail prematurely based on repeated pump interactions used to inflate and deflate the prosthesis. No injuries or device failures have been reported to date.

The affected units (Lot Numbers 8806758 and 8806757) were distributed worldwide, including the United States, Turkey, Italy, Germany, Belgium, France, United Kingdom, Spain, and Portugal. Approximately 11 units are affected.

The recalled product

Product
Titan Touch Scro Zero Ang 22cm, Catalog Number ES29222400; inflatable penile Prosthesis
Manufacturer
Coloplast Manufacturing US, LLC
Category
Medical Device — Sexual Health 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 (3)

  • UDI/DI 05708932539203
  • Lot Numbers: 8806758
  • 8806757

Distribution

Distributed nationwide across the United States.

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