Coloplast recalls Titan Touch NB Scrot Zero 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 NB Scrot Zero 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 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 Touch NB Scrot Zero 18cm inflatable penile prosthesis with catalog number EN29182400 and specific lot numbers are affected. Those with the product are at risk of potential pump failure.
Check for catalog number EN29182400 and lot numbers 8829594, 8849571, 8806760, or 8840685 on the product packaging or label.
Verify the catalog number EN29182400 and lot numbers 8829594, 8849571, 8806760, or 8840685 on the product packaging or label.
The recalled product is the Titan Touch NB Scrot Zero 18cm inflatable penile prosthesis with catalog number EN29182400.
Lot numbers 8829594, 8849571, 8806760, and 8840685 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-1364-2023 — Coloplast Coloplast Hello, I own a Coloplast that is covered by recall Z-1364-2023 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.
