Coloplast recalls Titan Pump devices for men with erectile dysfunction implants due to potential increased fracture risk over time. No remedy specified in official notice.
Potential increased occurrence of pump fracture over the lifetime of the device.
Coloplast is recalling Titan Pump devices intended for men with erectile dysfunction implants. The recall is due to a potential increased risk of pump fracture over the device's lifetime. This could lead to injury if the pump breaks.
The hazard is a potential increased occurrence of pump fracture over the lifetime of the device. This could happen due to normal use over time, but the exact mechanism isn't specified in the recall notice.
Men who use Titan Pump devices for erectile dysfunction implants are affected. Those with the specific model numbers listed in the recall are most at risk.
Check for the model numbers listed in the recall (e.g., 5585215, 5637061, etc.) on the device packaging or label. The Titan Pump is intended for male patients with erectile dysfunction who are candidates for penile prosthesis implants.
Look for the model numbers listed in the recall on the device packaging or label.
The recall is due to a potential increased occurrence of pump fracture over the lifetime of the device.
The official notice does not specify a remedy, so no action is required beyond checking the model numbers.
The recall states a potential increased occurrence of pump fracture, but does not specify if this could cause serious injury in normal use.
We’ve drafted a message you can send Coloplast to request your refund or repair — edit it as you like.
Subject: Recall Z-0488-2021 — Coloplast Coloplast Hello, I own a Coloplast that is covered by recall Z-0488-2021 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.
