Coloplast recalls Titan 0-Deg Scrotal 22 Cm inflatable penile prostheses with potential premature pump failure due to wall thickness issues. Affected units include specific catalog numbers and lot numbers. Consumers should contact Coloplast for details.
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 0-Deg Scrotal 22 Cm inflatable penile prostheses because a decrease in wall thickness may cause premature pump failure during use. This could lead to the device not functioning properly, potentially causing discomfort or complications for users.
The pump in the prosthesis has a reduced wall thickness that may fail prematurely when the device is inflated and deflated multiple times. This could cause the pump to stop working before it should, potentially leading to the device not functioning properly during use.
Men who own or use the recalled Titan 0-Deg Scrotal 22 Cm inflatable penile prosthesis with catalog number ES89222400 and specific lot numbers (8849602, 8904182, 8840688, 8849622) are affected. Those with the device are most at risk.
Check for the catalog number ES89222400 and lot numbers 8849602, 8904182, 8840688, or 8849622 on the product packaging or label. The product is an inflatable penile prosthesis with a 0-Deg Scrotal 22 Cm size.
Reach out to Coloplast directly for specific instructions on how to handle the recalled product.
The catalog number is ES89222400.
Lot numbers 8849602, 8904182, 8840688, and 8849622 are affected.
The recall record does not specify a fix; consumers should contact Coloplast for details.
We’ve drafted a message you can send Coloplast to request your refund or repair — edit it as you like.
Subject: Recall Z-1375-2023 — Coloplast Coloplast Hello, I own a Coloplast that is covered by recall Z-1375-2023 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.
