Agency classClass IIOur severity:High FDA (Devices)·Z-2347-2024·Announced 2024-07-17

Blood Pump Rotor Spare Parts Recalled for Loose Guide Sheaves

Fresenius Medical Care recalls 6 blood pump rotor spare parts used in dialysis machines due to loose or dislodged guide sheaves that developed after clinical use.

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 affecting a critical blood pump component used in life-support dialysis equipment. While no adverse events are explicitly reported in the recall notice, loose or dislodged guide sheaves pose a documented risk of device malfunction. The mechanical failure was confirmed across multiple units during clinical use.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling 6 blood pump rotor spare parts (Model F40015481 Rev A) used in dialysis machines. The recalled rotors are at risk of developing loose or dislodged guide sheaves after a period of use in clinical settings.

The specific units affected have the following serial numbers: 6K0S-514F, 6K0S-472G, 6K0S-052M, 6K0S-058N, 5K0S-322B, and 5K0S-U131. These components were distributed nationwide in the United States and in Canada.

Dialysis facilities currently using affected rotor components should discontinue use and contact Fresenius Medical Care Holdings, Inc. for replacement parts or additional guidance. Patients should consult with their healthcare provider if they have questions about whether they may have been affected by this recall.

The recalled product

Product: RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Manufacturer: Fresenius Medical Care Holdings, Inc.
Category: Medical Device — Dialysis Equipment
Hazard: mechanical-failure
device-malfunction
Affected units: 6

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 (8)

Model Number: RTLR190395 (Refurbished Rental units)
UDI/DI: 00840861100958
Serial Numbers: 6K0S-514F
6K0S-472G
6K0S-052M
6K0S-058N
5K0S-322B
5K0S-U131.

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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