Home › Zoll Circulation, Inc. › Thermogard XP®
Thermogard XP®
Zoll Circulation, Inc. · Model Thermogard XP, Lang set A, Rohs · UDI-DI 00849111075015
1
510(k) clearances
4,407
Adverse events (44 deaths)
35
Recalls
4
Facilities
Description
The THERMOGARD is an integrated electro-mechanical heater/cooler that consists of a temperature monitor, a temperature controller unit, a heat exchanger unit, and roller pump. It supplies temperature controlled sterile saline to the indwelling Catheter that is placed percutaneously in the patient.
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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData 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.