Coloplast recalls Titan Touch Pump (catalog 5177502400) 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 Touch Pumps with catalog number 5177502400 because the pump's wall thickness may fail prematurely, leading to improper function of the inflatable penile prosthesis. This could cause the device to malfunction during use.
The pump's wall thickness may decrease over time with repeated use, which could lead to premature failure. This might cause the pump to stop working properly during inflation or deflation cycles of the penile prosthesis.
Owners of the Titan Touch Pump with catalog number 5177502400 and specific lot numbers for inflatable penile prostheses are affected. Men using this type of medical device are most at risk.
Check for catalog number 5177502400 on the pump. Affected units include specific lot numbers: 8849559, 8849560, 8849623, 8887867, 8849624, 8497256, 8904186.
Verify the catalog number and lot numbers on your pump to confirm if it is affected.
The affected pumps have catalog number 5177502400.
Affected lot numbers include 8849559, 8849560, 8849623, 8887867, 8849624, 8497256, and 8904186.
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-1359-2023 — Coloplast Coloplast Hello, I own a Coloplast that is covered by recall Z-1359-2023 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.
