Terumo HX2 Temperature Management System Recalled for Valve Malfunction
Terumo is recalling 103 HX2 Temperature Management Systems because a malfunctioning mixing valve can cause loss of cooling or heating capability during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a medical device used during surgery where loss of temperature control poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 103 units of the HX2 Temperature Management System. This device provides temperature control for patient blood and cardioplegia solution during cardiovascular surgery. The recall covers units distributed nationwide in the United States and in Japan.
The recall is due to a malfunctioning mixing valve that can result in the loss of cooling and/or heating capability. When this occurs, the system goes to standby mode and displays error messages EOd or EOE, indicating that the valve is unable to move or complete a motion. The mixing valves require replacement at regular intervals.
Healthcare facilities should stop using the affected units and contact Terumo Cardiovascular Systems Corporation for instructions on replacing the mixing valves. The affected units are identified by specific catalog numbers and serial numbers listed in the official recall notice.
The recalled product
- Product
- 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.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Affected units
- 103
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 (10)
- HX2 Temperature Management System
- 120V Catalog # 809810 serial numbers: 00016
- 0001 1116 HX2 Temperature Management System
- 100V Catalog # 812231 serial numbers: 0001
- 1002
- PT0003
- PT0004 HX2 Temperature Management System
- 240V Catalog # 812240 serial numbers: 0001
- 0002 HX2 Temperature Management System
- Trial Kit Catalog # 809810TK serial numbers: 1001 1042
Distribution
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