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Recall Observatory FDA recall evidence

Device product

RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A

Z-2344-2024

June 03, 2024

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 94775
Status
Ongoing
Classification
Class II
Quantity
17 Units
Official record key
device-enforcement:Z-2344-2024

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: RTL190395 (Rental Units); UDI/DI: 00840861100958; Serial Numbers: 4K0S-R138, 5K0S-Z652, 5K0S-462B, 5K0S-Z669, 6K0S-505F, 6K0S-513F, 6K0S-850G, 6K0S-480J, 6K0S-467K, 6K0S-995P, 7K0S103784, 6K0S-009M, 7K0S110463, 7K0S110427, 7K0S110771, 6K0S-725R, 6K0S-324L,

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.