Coloplast recalls Titan Touch Scro Zero Ang 22cm inflatable penile prostheses (ES29222400) due to potential premature pump failure from reduced wall thickness. Affected units include specific lot numbers and UDI/DI codes.
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 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 it as intended.
The pump in these prostheses has thinner walls than standard, which may cause it to fail earlier during repeated inflation and deflation cycles. This could result in the device not working properly when needed.
Owners of the Titan Touch Scro Zero Ang 22cm inflatable penile prosthesis with specific catalog number ES29222400 and lot numbers 8806758 or 8806757 are affected. Men who use this type of medical device are most at risk.
Check for the catalog number ES29222400 and lot numbers 8806758 or 8806757 on the product. The unique device identifier (UDI/DI) 05708932539203 is also associated with these units.
Look for the catalog number ES29222400 and lot numbers 8806758 or 8806757 on the device.
The catalog number is ES29222400 for the Titan Touch Scro Zero Ang 22cm inflatable penile prosthesis.
Check for the catalog number ES29222400 and lot numbers 8806758 or 8806757 on the product. The unique device identifier (UDI/DI) 05708932539203 is also associated with these units.
The recall record does not specify a remedy, so there is no action required beyond checking if your device matches the affected details.
We’ve drafted a message you can send Coloplast to request your refund or repair — edit it as you like.
Subject: Recall Z-1371-2023 — Coloplast Coloplast Hello, I own a Coloplast that is covered by recall Z-1371-2023 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.
