Coloplast recalls Titan 0-Deg Scrotal 18 Cm inflatable penile prostheses with potential premature pump failure due to wall thickness issues. 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 Scrotal 18 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 after repeated inflation and deflation cycles. This could result in the device not working as intended during use.
Men who own or use the recalled Titan 0-Deg Scrotal 18 Cm inflatable penile prosthesis with the specified catalog number and lot numbers are affected. Those with the device are most at risk of experiencing pump failure.
Check for the catalog number ES89182400 and lot numbers 8849599, 8887865, 8939119, 8904178, or 8904179 on the product packaging or label.
Look for the catalog number ES89182400 and lot numbers 8849599, 8887865, 8939119, 8904178, or 8904179 on the product packaging or label.
The pump in these prostheses has thinner walls than standard, which may cause it to fail prematurely after repeated inflation and deflation cycles.
Check the product for the catalog number ES89182400 and lot numbers 8849599, 8887865, 8939119, 8904178, or 8904179. If you have these, contact Coloplast for further instructions.
The recall record does not specify a remedy or fix for this issue.
We’ve drafted a message you can send Coloplast to request your refund or repair — edit it as you like.
Subject: Recall Z-1373-2023 — Coloplast Coloplast Hello, I own a Coloplast that is covered by recall Z-1373-2023 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.
