Coloplast recalls Titan Touch NB Scrot Zero 16cm inflatable penile prostheses (Catalog EN29162400) due to potential premature pump failure from reduced wall thickness. Affected units have 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 NB Scrot Zero 16cm inflatable penile prostheses because the pump may fail prematurely due to reduced wall thickness. This could lead to improper function during use. Affected units have specific catalog numbers and lot numbers.
The pump in the prosthesis has reduced wall thickness compared to standard pumps, which may cause it to fail prematurely during inflation or deflation cycles. This could lead to improper function but does not typically cause injury.
Men who own or use the recalled Titan Touch NB Scrot Zero 16cm inflatable penile prosthesis with Catalog Number EN29162400 and Lot Numbers 8840684 are most at risk. The recall affects a specific batch of these medical devices.
Check for the Catalog Number EN29162400 and Lot Numbers 8840684 on the product. The UDI/DI code 05708932072557 is also associated with the recalled units.
Look for the Catalog Number EN29162400 and Lot Numbers 8840684 on the device.
The pump may fail prematurely due to reduced wall thickness, which could affect proper function during inflation or deflation cycles.
Check for the Catalog Number EN29162400 and Lot Numbers 8840684 on the device, or the UDI/DI code 05708932072557.
The recall does not specify a remedy, so contact Coloplast directly for guidance.
We’ve drafted a message you can send Coloplast to request your refund or repair — edit it as you like.
Subject: Recall Z-1363-2023 — Coloplast Coloplast Hello, I own a Coloplast that is covered by recall Z-1363-2023 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.
