Terumo HX2 Temperature Management System Recalled for Board Defects
Terumo is recalling 19 HX2 Temperature Management Systems because AC Control boards were manufactured with incorrect flux, which may cause premature failure.
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: The recall involves a high-risk medical device where a defect (premature board failure) poses a risk of harm, and the source text reports three specific complaints related to failure, fitting the criteria for a High severity score.
Plain-English summary
Terumo Cardiovascular Systems Corporation is recalling 19 units of the HX2 Temperature Management System. This self-contained, dual-channel system supplies temperature-controlled water to heat exchangers used in extracorporeal circuits. The recall was initiated after a retrospective review of quality data identified that the AC Control boards used in the manufacture of these systems were produced using the incorrect flux material.
The use of incorrect flux may contribute to premature board failure. A search of Terumo Cardiovascular Systems Corporation (TCVS) complaints revealed three complaints related to HX2 failure, with each failure occurring during setup. The affected units were distributed nationwide, including in California, Hawaii, Kansas, Louisiana, Michigan, Missouri, Oregon, Pennsylvania, Utah, and Wisconsin.
Affected units have catalog number 809810 and serial numbers 1041, 1083, 1084, and 1101-1116. Users should contact Terumo Cardiovascular Systems Corporation for instructions on how to return or replace the affected equipment.
The recalled product
- Product
- HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
- Manufacturer
- Terumo Cardiovascular Systems Corporation
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 19
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 (4)
- Catalog number: 809810 and serial numbers: 1041
- 1083
- 1084
- and 1101-1116.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Terumo Cardiovascular Systems Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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