The Recall Desk
HighFDA (Devices)·Z-1789-2021·Announced 2021-06-09

Terumo HX2 and TCM Temperature Management Systems Recalled for Cleaning Protocol Issues

Terumo recalled the HX2 and TCM temperature management systems used in cardiac surgery due to inability to validate an updated cleaning protocol. Users should discontinue use and properly dispose of affected devices.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II medical device recall affecting cardiac surgery equipment where a validated cleaning protocol could not be established. While no patient illnesses, injuries, or deaths have been reported, the potential for contamination and inadequate sterilization in high-risk cardiac surgical equipment represents a significant risk of harm.

Plain-English summary

Terumo Cardiovascular Systems Corporation has issued a recall of the HX2 Temperature Management System and related TCM I and TCM II temperature management systems. These medical devices are used during cardiovascular surgery to control the temperature of patient blood and cardioplegia solution during cardiac procedures. The HX2 system consists of a water tank, circulating pumps, heater manifolds, temperature sensors, water detectors, and related components. All devices with lot numbers distributed from May 2, 1985 through June 10, 2015 are affected by this recall.

Terumo has been unable to validate a cleaning and sterilization protocol that satisfies current FDA regulatory requirements and expectations. The company determined that it cannot develop an updated cleaning protocol to resolve this issue. As a result, Terumo advises all users to immediately discontinue use of and properly dispose of affected HX2, TCM I, and TCM II devices.

The recall affects devices distributed in the United States and internationally to over 35 countries including Canada, Australia, Japan, France, Germany, Mexico, and others. Healthcare facility staff should immediately contact their medical device coordinators and coordinate with Terumo Cardiovascular Systems Corporation for proper device disposal guidance and replacement information. No patient illnesses, injuries, or deaths have been reported in connection with this cleaning protocol issue.

The recalled product

Product
The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery. The system consists of a water tank, circulating pumps,
Manufacturer
Terumo Cardiovascular Systems Corporation
Category
Medical Device — Cardiac Surgery Equipment
Hazard
  • sterilization-failure
  • contamination-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lot numbers distributed from 05/02/1985 thru 06/10/2015

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category