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Thermogard HQTM Start-Up Kit

Zoll Circulation, Inc. · Model TG2-500D · UDI-DI 00849111075862

NCX

510(k) clearances

4,407

Adverse events (44 deaths)

Recalls

Facilities

Description

The ZOLL® Intravascular Temperature Management (IVTM™) System is comprised of an external heat exchange console (Thermogard HQ™ console) and intravascular heat exchange catheter connected via a sterile heat exchanger and tubing circuit (Thermogard HQTM Start-Up Kit or Thermogard HQTM Start-Up Kit EX). These components together comprise a patient temperature regulation apparatus employing feedback control. The subject devices of this submission are the proposed Thermogard HQTM Console, Thermogard HQTM Start-Up Kit and Thermogard HQTM Start-Up Kit EX.

Recalls

Date	Firm	Reason
2021-08-06	ZOLL Circulation, Inc.	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06	ZOLL Circulation, Inc.	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06	ZOLL Circulation, Inc.	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06	ZOLL Circulation, Inc.	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06	ZOLL Circulation, Inc.	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06	ZOLL Circulation, Inc.	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06	ZOLL Circulation, Inc.	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06	ZOLL Circulation, Inc.	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06	ZOLL Circulation, Inc.	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
2021-08-06	ZOLL Circulation, Inc.	Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.