Coloplast recalls Titan Touch Infr Zero Ang 18cm inflatable penile prostheses with potential premature pump failure due to wall thickness issues. Affected units have specific catalog 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 18cm inflatable penile prostheses because a decrease in wall thickness may cause premature pump failure. This could lead to the device not functioning properly during use.
The pump in the prosthesis has thinner walls than standard, which may lead to premature failure after repeated inflation and deflation cycles. This could cause the device to stop working before intended use.
Men who own the recalled Titan Touch Infr Zero Ang 18cm inflatable penile prosthesis with catalog number ES28182400 and specific lot numbers are affected. Those most at risk are users who experience pump failure during use.
Check for the catalog number ES28182400 and lot numbers 8849582, 8849603, or 8904185 on the product packaging. The product is an inflatable penile prosthesis from Coloplast Manufacturing US, LLC.
Verify the catalog number ES28182400 and lot numbers 8849582, 8849603, or 8904185 on the product packaging.
A decrease in wall thickness may cause premature pump failure compared to standard pumps, potentially leading to the device not functioning properly during use.
Check for the catalog number ES28182400 and lot numbers 8849582, 8849603, or 8904185 on the product packaging.
The recall record does not specify a remedy, so contact Coloplast Manufacturing US, LLC directly for guidance.
We’ve drafted a message you can send Coloplast to request your refund or repair — edit it as you like.
Subject: Recall Z-1367-2023 — Coloplast Coloplast Hello, I own a Coloplast that is covered by recall Z-1367-2023 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.