Hemodialysis System Blood Pump Rotor Recall Due to Loose Sheaves
Fresenius is recalling blood pump rotors in home hemodialysis systems due to loose or dislodged guide sheaves reported during clinical use. The defect could affect proper pump operation during dialysis treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for a functional defect in a hemodialysis system component. A loose blood pump rotor poses a risk of treatment interruption or complications in a life-sustaining dialysis device. While no patient illnesses or injuries are reported in the source material, this qualifies as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling the Blood Pump Rotor (Part Number F40015481 Rev A) used in the RTL190904 2008K@HOME Hemodialysis System with BiBAG. This spare part is used in specific home hemodialysis units.
The recall was initiated after an increased number of reports were received from clinics noting that guide sheaves in the rotor had become loose or dislodged following a period of use. A loose rotor component could affect the proper operation of the blood pump during dialysis treatment.
The affected rotor units have Model Number RTL190904 and were distributed nationwide in the United States and to Canada. The recalled units carry serial numbers 5K0S193320 and 5K0S194164, with UDI/DI code 00840861100965.
If you use or manage one of the affected hemodialysis systems, contact Fresenius Medical Care Holdings, Inc. immediately for instructions on inspecting your equipment or receiving a replacement rotor.
The recalled product
- Product
- RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model Number: RTL190904 (Rental Units)
- UDI/DI: 00840861100965
- Serial Numbers: 5K0S193320
- 5K0S194164.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Fresenius Medical Care Holdings, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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