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Recall Observatory FDA recall evidence

Device product

Blood Pump Rotor, Model Number: F40015481 Rev A

Z-1866-2024

April 17, 2024

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 94463
Status
Ongoing
Classification
Class II
Quantity
45,880 components
Official record key
device-enforcement:Z-1866-2024

Official wording

Reason: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.

Code information: Model Number: F40015481 Rev A, UDI/DI: N/A, All Rev A lots.

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.