Fresenius Medical Care recalls blood pump rotor spare parts (model F40015481 Rev A) due to reported loose guide sheaves in clinics. Affected units include specific serial numbers and refurbished rental models.
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 blood pump rotor spare parts (model F40015481 Rev A) after clinics reported loose or dislodged guide sheaves. This could lead to pump malfunction during use, potentially causing blood flow issues in hemodialysis machines.
The blood pump rotor spare part (model F40015481 Rev A) can become loose or dislodged after use, which may cause the pump to malfunction. This could lead to improper blood flow during hemodialysis treatments, potentially causing complications for patients.
Clinics using the 2008K@HOME blood pump machine with the specified model number and serial numbers are affected. Patients receiving hemodialysis through these machines are at risk if the rotor becomes loose.
Check if your blood pump rotor has the model number F40015481 Rev A and serial numbers listed: 6K0S-514F, 6K0S-472G, 6K0S-052M, 6K0S-058N, 5K0S-322B, or 5K0S-U131. This part was sold as refurbished rental units under the model RTLR190395.
Inspect the blood pump rotor for loose or dislodged guide sheaves. If loose, stop using the machine immediately.
Clinics reported an increased number of complaints about loose or dislodged guide sheaves on the blood pump rotor after use.
The affected model is F40015481 Rev A, with serial numbers 6K0S-514F, 6K0S-472G, 6K0S-052M, 6K0S-058N, 5K0S-322B, and 5K0S-U131.
The recall record does not specify a remedy or fix for this issue.
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-2347-2024 — Fresenius Medical Care Fresenius Medical Care Hello, I own a Fresenius Medical Care that is covered by recall Z-2347-2024 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.
