The Recall Desk
HighFDA (Devices)·Z-1866-2024·Announced 2024-05-29

Blood Pump Rotor Model F40015481 Rev A Recalled for Loose Guide Sheaves

Fresenius Medical Care is recalling 45,880 Blood Pump Rotors (Model F40015481 Rev A) due to reports of loose or dislodged guide sheaves after use in clinical facilities.

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 a risk-of-harm medical device product with reported mechanical failure of a critical rotor component. Although no illnesses or injuries have been reported, the guide sheave failure could compromise device function. Per the severity rubric, risk-of-harm products without reported injury are classified as High.

Plain-English summary

Fresenius Medical Care Holdings, Inc. is recalling 45,880 Blood Pump Rotors, Model Number F40015481 Rev A, distributed nationwide in the United States for clinical use.

Clinics have reported an increased number of complaints about loose or dislodged guide sheaves on the rotor following use. The manufacturer initiated this recall in response to these mechanical failure reports.

The recall affects all Rev A lots of this model. Affected healthcare facilities should contact Fresenius Medical Care Holdings, Inc. for guidance on device replacement or remediation.

The recalled product

Product
Blood Pump Rotor, Model Number: F40015481 Rev A
Manufacturer
Fresenius Medical Care Holdings, Inc.
Category
Medical Device
Hazard
  • component-failure

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 (3)

  • Model Number: F40015481 Rev A
  • UDI/DI: N/A
  • All Rev A lots.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category