Fresenius Medical recalls blood pump rotor spare parts (Model F40015481 Rev A) due to reported loose/dislodged guide sheaves in clinics. Affected units have specific serial numbers and model identifiers.
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Fresenius Medical is recalling blood pump rotor spare parts for the 2008K@HOME machine. Clinics reported loose or dislodged guide sheaves after use, which could lead to mechanical failure in blood pumps.
The spare part has been reported to become loose or dislodged after use in clinics. This could cause mechanical failure in the blood pump, potentially affecting patient safety during blood treatment procedures.
Clinics using the 2008K@HOME blood pump machine with the specific spare part model (F40015481 Rev A) are affected. Patients receiving blood treatments through these machines may be at risk if the spare part fails.
Check if your blood pump rotor spare part has the model number F40015481 Rev A. Affected units include specific serial numbers listed in the recall notice.
Verify the model number on your spare part is F40015481 Rev A.
Clinics reported loose or dislodged guide sheaves after using this spare part, which could lead to mechanical failure in blood pumps.
Check if your spare part has the model number F40015481 Rev A. If it does, contact Fresenius Medical for further instructions.
The recall is based on reports of loose/dislodged guide sheaves, but no specific injuries have been reported. The risk is considered low as it is a spare part issue.
We’ve drafted a message you can send Fresenius Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2344-2024 — Fresenius Medical Fresenius Medical Hello, I own a Fresenius Medical that is covered by recall Z-2344-2024 from Fresenius Medical. 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.
