Coloplast recalls Titan Touch Infr Zero Ang 22cm inflatable penile prostheses with potential premature pump failure due to wall thickness issues. Affected units include specific catalog numbers and lot numbers.
A decrease in wall thickness has the potential for a premature pump failure, compared to a pump with standard wall thickness, based on the number of interactions with the pump to inflate and deflate the penile prosthesis.
Coloplast is recalling certain Titan Touch Infr Zero Ang 22cm inflatable penile prostheses because a decrease in wall thickness may cause premature pump failure during use. This could lead to the device not functioning properly, potentially affecting the user's ability to use the prosthesis as intended.
The pump in the prosthesis has a reduced wall thickness compared to standard models, which may cause it to fail prematurely after repeated inflation and deflation cycles. This could result in the device not functioning properly when needed.
Owners of the recalled Titan Touch Infr Zero Ang 22cm inflatable penile prostheses with catalog number ES28222400 and specific lot numbers (8849563, 8849585, 8904187) are affected. Individuals using these devices are at risk of premature pump failure.
Check for the catalog number ES28222400 and lot numbers 8849563, 8849585, or 8904187 on the product packaging or label. The product is an inflatable penile prosthesis from Coloplast Manufacturing US, LLC.
Identify the catalog number and lot numbers on the product to confirm if it is affected.
The recalled model is the Titan Touch Infr Zero Ang 22cm inflatable penile prosthesis with catalog number ES28222400.
Lot numbers 8849563, 8849585, and 8904187 are affected.
The recall record does not specify a remedy.
We’ve drafted a message you can send Coloplast to request your refund or repair — edit it as you like.
Subject: Recall Z-1368-2023 — Coloplast Coloplast Hello, I own a Coloplast that is covered by recall Z-1368-2023 from Coloplast. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
