Coloplast recalls Titan NB Infra Zero Ang 16cm inflatable penile prostheses (EN88162400) due to potential premature pump failure from decreased wall thickness. Affected units include specific catalog numbers 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 NB Infra Zero Ang 16cm inflatable penile prostheses because the pump may fail prematurely due to reduced wall thickness. This could lead to complications during use if the device fails unexpectedly.
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 lead to unexpected device failure while in use.
Men who own or use the recalled Titan NB Infra Zero Ang 16cm inflatable penile prosthesis with catalog number EN88162400 and specific lot numbers are affected. Those with the device are at risk of premature pump failure.
Check for the catalog number EN88162400 and lot numbers 8887620 or 8939124 on the product packaging. The device is sold under the brand Coloplast.
Verify the catalog number EN88162400 and lot numbers 8887620 or 8939124 on the device packaging.
The pump may fail prematurely due to decreased wall thickness, which could lead to unexpected device failure during use.
The recall record does not specify a remedy, so check with Coloplast directly for guidance.
Look for the catalog number EN88162400 and lot numbers 8887620 or 8939124 on the packaging.
We’ve drafted a message you can send Coloplast to request your refund or repair — edit it as you like.
Subject: Recall Z-1365-2023 — Coloplast Coloplast Hello, I own a Coloplast that is covered by recall Z-1365-2023 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.
