Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2344-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: June 3, 2024

Date Posted: July 17, 2024

Recall Number: Z-2344-2024

Event ID: 94775

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 17 Units

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.

Voluntary or Mandated:

Voluntary: Firm initiated