Coloplast recalls Titan Pump Assembly (Catalog 5177701400) due to potential premature pump failure from decreased wall thickness. Affected units include specific lot numbers for inflatable penile prostheses.
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 Titan Pump Assemblies (Catalog Number 5177701400) for inflatable penile prostheses. The recall is due to a potential risk of premature pump failure caused by reduced wall thickness in the pump assembly.
The pump assembly has decreased wall thickness compared to standard pumps, which may lead to premature failure during use. This could happen after multiple inflations and deflations of the penile prosthesis.
Owners of inflatable penile prostheses with the Titan Pump Assembly (Catalog Number 5177701400) and specific lot numbers (8904177, 8849617) are affected. Men using these prostheses are most at risk.
Check for the Titan Pump Assembly with Catalog Number 5177701400. Affected units have lot numbers 8904177 or 8849617. The product is sold under UDI/DI 05708932319621.
Identify the Catalog Number 5177701400 and lot numbers 8904177 or 8849617 on your Titan Pump Assembly.
The recalled pump is the Titan Pump Assembly with Catalog Number 5177701400.
Lot numbers 8904177 and 8849617 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-1360-2023 — Coloplast Coloplast Hello, I own a Coloplast that is covered by recall Z-1360-2023 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.
