Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2018 - (Recall #: Z-1416-2018)

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:

Terumo HX2 Temperature Management System, Catalog No. 809810 The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.

Product Classification:

Class II

Date Initiated: March 16, 2018

Date Posted: April 25, 2018

Recall Number: Z-1416-2018

Event ID: 79652

Reason for Recall:

Update to cooler-heater cleaning instructions.

Status: Terminated

Product Quantity: 2393 this total is for all products

Code Information:

All Lot Codes

Distribution Pattern:

Worldwide Distribution: US (Nationwide), Australia, Belgium, Canada, Chile, China. Colombia, Dominican Republic, England, Finland, France, Germany, Greece, HK, India, Indonesia, Iran. Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates,and Vietnam.

Voluntary or Mandated:

Voluntary: Firm initiated