Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2021 - (Recall #: Z-2350-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Terumo Advanced Perfusion System 1 Electronic Patient Gas System Catalog #: 801188

Product Classification:

Class II

Date Initiated: June 8, 2021

Date Posted: September 1, 2021

Recall Number: Z-2350-2021

Event ID: 88350

Reason for Recall:

intermittent failure causes a blender initialization fault upon start-up, or during an EPGS calibration attempt following the 15-minute warm-up period. The control sliders on the Central Control Monitor (CCM) are disabled and the gas system can only be controlled by the local control knobs

Status: Terminated

Product Quantity: 1 unit OUS

Code Information:

S/N: 01751 UDI: 00886799000588

Distribution Pattern:

International distribution in the country of Panama.

Voluntary or Mandated:

Voluntary: Firm initiated