Fresenius Medical Care recalls 190395 blood pump rotor spare parts (model F40015481 Rev A) due to reported loose/dislodged guide sheaves in clinics. Affected units have specific serial numbers listed in the recall notice.
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 Care is recalling a specific blood pump rotor spare part (model F40015481 Rev A) because clinics have reported loose or dislodged guide sheaves after use. This part is used in 2008K@HOME machines and may cause mechanical issues if not properly secured.
The blood pump rotor spare part has been reported to become loose or dislodged in clinics after use, which could lead to mechanical issues with the blood pump system. This may affect the proper functioning of the machine and potentially cause complications for patients.
Healthcare facilities that use the 2008K@HOME machines with the recalled blood pump rotor spare part (model F40015481 Rev A) are most at risk. Patients using these machines could experience mechanical issues if the part becomes loose.
Check if your 2008K@HOME machine has the blood pump rotor spare part with model number F40015481 Rev A and the listed serial numbers in the recall notice. The recall includes specific serial numbers starting with 4K0S, 5K0S, 6K0S, or 7K0S.
Inspect the blood pump rotor spare part for signs of looseness or dislodgement. If loose, stop using the machine immediately.
Reach out to Fresenius Medical Care for guidance on the specific model and serial numbers affected by this recall.
The model number is F40015481 Rev A.
The recall affects 2008K@HOME machines with the specific blood pump rotor spare part model F40015481 Rev A.
Check if your part has the model number F40015481 Rev A and one of the listed serial numbers in the recall notice.
We’ve drafted a message you can send Fresenius Medical Care to request your refund or repair — edit it as you like.
Subject: Recall Z-2343-2024 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-2343-2024 from Fresenius Medical Care. 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.
