Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2024 - (Recall #: Z-2342-2024)

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:

191014: 2008K@HOME HD SYSTEM W/BIBAG (CANADA) - 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-2342-2024

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: 20 units (all OUS)

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.

Voluntary or Mandated:

Voluntary: Firm initiated