Agency classClass IIOur severity:High FDA (Devices)·Z-2342-2024·Announced 2024-07-17

Blood Pump Rotor Spare Part Recalled for Loose Guide Sheaves

Fresenius Medical Care recalls a blood pump rotor spare part used in dialysis systems in Canada due to reports of loose or dislodged guide sheaves after use. No injuries have been reported.

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: FDA Class II medical device with no reported illnesses or injuries. The defect—loose guide sheaves in a critical dialysis equipment component—represents a risk-of-harm product where actual injury has not yet been documented. Per rubric criteria, this qualifies as High severity.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling the 2008K@HOME HD System blood pump rotor spare part (Model F40015481 Rev A) distributed in Canada. The recall affects 20 units.

Clinic operators reported an increased number of complaints about loose or dislodged guide sheaves on the blood pump rotor after it had been in use. This defect could potentially affect the proper operation of the dialysis system during treatment.

If you have received or are using this blood pump rotor spare part, discontinue use and contact Fresenius Medical Care Holdings, Inc. for a replacement or further instructions.

The recalled product

Product: 191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Manufacturer: Fresenius Medical Care Holdings, Inc.
Category: Medical Device — Dialysis Equipment
Hazard: loose-component
equipment-failure
Affected units: 20

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: 191014
UDI/DI: N/A (Canada only)
Serial Number: 6K0S162351
6K0S162352
6K0S162353
6K0S162354
6K0S162355
6K0S169113
6K0S169114
6K0S169115
6K0S169116
6K0S169117
6K0S169118
6K0S169119
6K0S169120
6K0S169121
6K0S169122
6K0S169123
6K0S169124
6K0S169125

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.

See all 8 products in this recall →

Same manufacturer · Fresenius Medical Care Holdings, Inc.

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