Blood Pump Rotor Guide Sheaves May Loosen in Home Hemodialysis System
Fresenius is recalling Blood Pump Rotor components in 2008K@HOME hemodialysis systems due to reports of loose or dislodged guide sheaves that could affect pump function. Affected patients should contact their clinic to verify involvement.
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 a risk-of-harm medical device product where no injuries have yet been reported. Loose or dislodged guide sheaves in a blood pump component used for life-sustaining dialysis treatment could impair the device's function. Although the source documents no hospitalizations or illnesses, the mechanical defect poses potential patient safety risk.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling certain Blood Pump Rotor spare parts (Model Number F40015481 Rev A) used in the 2008K@HOME Hemodialysis System. This recall affects 531 units.
The recall was initiated following increased complaints from clinics reporting that the guide sheaves on the Blood Pump Rotor became loose or dislodged during use. Loose or dislodged sheaves may affect the proper functioning of the blood pump during dialysis treatment.
The recalled devices were distributed nationwide in the United States and in Canada. The FDA classified this as a Class II recall. Affected units can be identified by the specific model number (F40015481 Rev A) and the serial numbers documented in the FDA recall notice.
Patients using the 2008K@HOME Hemodialysis System should contact their healthcare provider or clinic to determine if their device is affected. If an affected unit is identified, patients should work with Fresenius and their clinic to obtain a replacement or repaired component.
The recalled product
- Product
- 190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 531
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 (20)
- Model Number: 190828
- UDI/DI: 00840861100941
- Serial Numbers: 2K0S179489
- 3K0S184885
- 3K0S185744
- 1K0S172050
- 1K0S172202
- 1K0S171823
- 1K0S172056
- 3K0S185989
- 3K0S186038
- 4K0S190849
- 4K0S191132
- 1K0S171846
- 4K0S192532
- 4K0S192534
- 4K0S192232
- 4K0S191583
- 2K0S180629
- 3K0S185738
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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