Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2018 - (Recall #: Z-1478-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Flowmeter Module (accessory to Terumo Advanced Perfusion System 1). Provides the interface between the flow sensor and the system.

Product Classification:

Class II

Date Initiated: January 19, 2018

Date Posted: May 2, 2018

Recall Number: Z-1478-2018

Event ID: 79624

Reason for Recall:

Inaccurrate flow readings. Depending on the degree of inaccuracy, this issue may not be easy for the user to detect during setup or use (for example, following a Flow Probe relocation or manipulation).

Status: Terminated

Product Quantity: 7

Code Information:

Catalog # - 802018 Serial #: 01662, 01672, 01680, 01681,01682, 01683 , and 01687. UDI: 00886799000687.

Distribution Pattern:

Worldwide Distribution -- USA, including the states of IL, KY, and MI; and, the country of Singapore.

Voluntary or Mandated:

Voluntary: Firm initiated