Fresenius Medical Care Holdings, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1866-2024)

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:

Blood Pump Rotor, Model Number: F40015481 Rev A

Product Classification:

Class II

Date Initiated: April 17, 2024

Date Posted: May 29, 2024

Recall Number: Z-1866-2024

Event ID: 94463

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: 45,880 components

Code Information:

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

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated