Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2019 - (Recall #: Z-1337-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit.

Product Classification:

Class II

Date Initiated: April 18, 2019

Date Posted: May 22, 2019

Recall Number: Z-1337-2019

Event ID: 82630

Reason for Recall:

The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.

Status: Terminated

Product Quantity: 1258

Code Information:

All

Distribution Pattern:

Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Chile, Hong Kong, Indonesia, Japan, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, and United Arab Emirates.

Voluntary or Mandated:

Voluntary: Firm initiated