Coloplast recalls Titan 0-Deg Infrapubic 20 Cm inflatable penile prostheses due to potential premature pump failure from decreased wall thickness. Affected units have 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 0-Deg Infrapubic 20 Cm 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 these prostheses has thinner walls than standard, which may cause it to fail prematurely during inflation or deflation cycles. This could result in the device not working as intended when needed.
Men who own or use the recalled Titan 0-Deg Infrapubic 20 Cm inflatable penile prosthesis with catalog number ES88202400 and lot numbers 8849577 or 8849578 are most at risk. These units were sold with specific UDI/DI numbers.
Check for the catalog number ES88202400 and lot numbers 8849577 or 8849578 on the product. The UDI/DI number 05708932487245 is also associated with these units.
Verify the catalog number ES88202400 and lot numbers 8849577 or 8849578 on the device.
The recalled product is the Titan 0-Deg Infrapubic 20 Cm inflatable penile prosthesis with catalog number ES88202400.
Lot numbers 8849577 and 8849578 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-1372-2023 — Coloplast Coloplast Hello, I own a Coloplast that is covered by recall Z-1372-2023 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.
