Coloplast recalls Titan Touch NB Infr Zero 16cm inflatable penile prostheses (Catalog EN28162400) 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 Infr Zero 16cm inflatable penile prostheses because they may fail prematurely due to reduced wall thickness. This could lead to improper function and require medical intervention.
The pump in these prostheses has thinner walls than standard, which may cause it to fail prematurely during inflation or deflation cycles. This could lead to improper function or require medical intervention if the device fails unexpectedly.
Men who own or use the recalled Titan Touch NB Infr Zero 16cm inflatable penile prosthesis (Catalog Number EN28162400) with Lot Numbers 8887609 or UDI/DI 05708932072519 are affected. Men with this specific medical device are most at risk.
Check for the Catalog Number EN28162400 on the device. Affected units have Lot Numbers 8887609 or UDI/DI 05708932072519.
Look for the Catalog Number EN28162400, Lot Numbers 8887609, or UDI/DI 05708932072519 on the device.
The recalled device is the Titan Touch NB Infr Zero 16cm inflatable penile prosthesis with Catalog Number EN28162400.
Check the device for the Catalog Number EN28162400, Lot Numbers 8887609, or UDI/DI 05708932072519. If you have these identifiers, contact Coloplast for further instructions.
The recall states a potential for premature pump failure, which could lead to improper function or require medical intervention, but the record does not specify a risk of serious injury.
We’ve drafted a message you can send Coloplast to request your refund or repair — edit it as you like.
Subject: Recall Z-1361-2023 — Coloplast Coloplast Hello, I own a Coloplast that is covered by recall Z-1361-2023 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.
