The Recall Desk
HighFDA (Devices)·Z-1868-2024·Announced 2024-05-29

Fresenius 2008T BlueStar Hemodialysis Machine Recalled for Loose Blood Pump Rotor

Fresenius is recalling 12,292 BlueStar hemodialysis machines because the blood pump rotor component can develop loose or dislodged guide sheaves after clinical use. Patients should contact their healthcare provider to verify if their equipment is affected.

What this means for you

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 recall of a critical medical device with no reported illnesses or injuries. The mechanical defect in the blood pump rotor could affect device function, representing a risk-of-harm scenario; however, no patient harm has been confirmed, placing it at the High severity level per the rubric.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling 12,292 units of the 2008T BlueStar Hemodialysis Machine, Model 191126, due to a defect in the blood pump rotor component (Model F40015481 Rev A). The devices were distributed nationwide in the United States.

After a period of clinical use, the blood pump rotor component can develop loose or dislodged guide sheaves. An increased number of complaints regarding this mechanical defect have been reported by clinics using the affected equipment. Since the rotor is a critical component in the dialysis process, any malfunction poses a risk to patients dependent on the machine for treatment.

Patients and healthcare facilities using the affected machines should verify their equipment against the list of recalled serial numbers provided in the official FDA recall notice. If your machine is included in the recall, contact Fresenius Medical Care or your healthcare provider immediately for guidance on next steps, including replacement or corrective measures.

The recalled product

Product
2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Manufacturer
Fresenius Medical Care Holdings, Inc.
Category
Medical Device — Hemodialysis Equipment
Hazard
Affected units
12,292

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)

  • Component: Model Number: F40015481 Rev A
  • UDI/DI: N/A
  • All Rev A lots. Finished Devices: Model Number: 191126
  • UDI/DI: 00840861102099
  • Serial Numbers: 3T0S270687
  • 3T0S270700
  • 3T0S274007
  • 3T0S274009
  • 3T0S274011
  • 3T0S274012
  • 3T0S274016
  • 3T0S274057
  • 3T0S274859
  • 3T0S274920
  • 3T0S274922
  • 3T0S274923
  • 3T0S274938
  • 3T0S274957
  • 3T0S274969
  • 3T0S274970

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

Related recalls

Same manufacturer · Fresenius Medical Care Holdings, Inc.

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Same hazard · mechanical defect

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