The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1369-2023·Announced 2023-04-19

Inflatable Penile Prosthesis Recalled for Premature Pump Failure Risk

Coloplast is recalling Titan Touch Scro Zero Ang 16cm prostheses (Lot 8840677) due to decreased wall thickness that may cause premature pump failure. Affected devices were distributed worldwide, including throughout the US.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II recall for a manufacturing defect creating risk of device failure. No illnesses or injuries reported, making this a theoretical risk-of-harm scenario where a defective medical device could fail during use without established harm history.

Plain-English summary

Coloplast Manufacturing US, LLC is recalling the Titan Touch Scro Zero Ang 16cm inflatable penile prosthesis (Catalog Number ES29162400, UDI/DI 05708932539173) due to a manufacturing defect. Affected units with Lot Number 8840677 have decreased wall thickness compared to devices manufactured to specification. This reduction in wall thickness creates a potential for premature pump failure based on the number of inflate and deflate cycles performed during normal use.

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

Users of the affected prosthesis should contact Coloplast Manufacturing US, LLC or consult their healthcare provider to discuss the risk and any appropriate next steps. The FDA encourages anyone who has experienced a problem with this device to report it through the MedWatch program.

The recalled product

Product
Titan Touch Scro Zero Ang 16cm, Catalog Number ES29162400; inflatable penile Prosthesis
Manufacturer
Coloplast Manufacturing US, LLC
Category
Medical Device — Implantable Medical Device
Hazard
Affected units
1

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 05708932539173
  • Lot Numbers: 8840677

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 →

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