Coloplast recalls Titan Touch Scro Zero Ang 16cm inflatable penile prostheses (ES29162400) due to potential premature pump failure from reduced wall thickness. 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 Scro Zero Ang 16cm inflatable penile prostheses because a decrease in wall thickness may cause the pump to fail prematurely during use. This could lead to complications if the device stops working unexpectedly.
The pump in the prosthesis has thinner walls than standard, which may cause it to fail earlier than expected when inflating or deflating the device. This could happen after repeated use cycles, potentially leading to unexpected device failure.
Men who own or use the recalled Titan Touch Scro Zero Ang 16cm inflatable penile prosthesis (catalog number ES29162400) are affected. Those with the specific lot numbers or UDI/DI codes are most at risk.
Check for the catalog number ES29162400 on the product. Affected units also have UDI/DI code 05708932539173 and lot numbers starting with 8840677.
Verify the catalog number ES29162400 and UDI/DI code 05708932539173 on the device.
The recall indicates a potential risk of premature pump failure, so it is recommended to check if your device is affected before continuing use.
The recall does not specify a remedy, so you should check the product details to confirm if it is affected and contact Coloplast for further guidance.
Look for the catalog number ES29162400, UDI/DI code 05708932539173, and lot numbers starting with 8840677 on the device.
We’ve drafted a message you can send Coloplast to request your refund or repair — edit it as you like.
Subject: Recall Z-1369-2023 — Coloplast Coloplast Hello, I own a Coloplast that is covered by recall Z-1369-2023 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.
