Terumo recalls HX2 Temperature Management System (P/N 809810) from 1985-2015 due to inability to validate cleaning protocol. Users must stop using and dispose of devices to prevent potential safety risks.
Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices.
Terumo is recalling its HX2 Temperature Management System used in heart surgery. The system cannot be cleaned safely as per regulatory standards, so users must stop using and dispose of it immediately.
The system's cleaning protocol could not be validated to meet regulatory safety standards. This means the device might not be clean enough during use, potentially causing infections or other complications during heart surgery.
Heart surgery patients and medical staff who use the HX2 Temperature Management System (model P/N 809810) from May 1985 through June 2015 are affected. Those with the device are at immediate risk due to the safety issue.
Check for the model number P/N 809810 on the device. The product was sold from May 2, 1985, through June 10, 2015.
Discontinue use of the HX2 Temperature Management System and dispose of it safely.
Terumo CVS has been unable to validate a cleaning protocol to meet regulatory safety standards, so they must stop using the device.
The HX2 Temperature Management System with model number P/N 809810.
From May 2, 1985, through June 10, 2015.
We’ve drafted a message you can send Terumo to request your refund or repair — edit it as you like.
Subject: Recall Z-1789-2021 — Terumo Terumo Hello, I own a Terumo that is covered by recall Z-1789-2021 from Terumo. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
