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Recall Observatory FDA recall evidence

Device product

191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

Z-2342-2024

June 03, 2024

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 94775
Status
Ongoing
Classification
Class II
Quantity
20 units (all OUS)
Official record key
device-enforcement:Z-2342-2024

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: 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, 6K0S169126, 6K0S169127.

Distribution pattern: Domestic: Nationwide Distribution. International: Canada.

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.