Devices › System, hypothermia, intravenous, cooling

Device brand name · Intravascular core temperature regulation system

Thermogard XP: medical device reports filed with FDA

331 reports name it, 2024–2026. Manufacturer given most often on reports: Zoll Circulation. Product code NCX.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

331
device reports naming the brand: 0% of all MAUDE reports · about 159 a year; 163
reports, 12 months to August 2026: 140 in the 12 months before; 100%
classified as malfunction: 92.9% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

FDA's MAUDE database holds 331 reports that name the brand "Thermogard XP" (intravascular core temperature regulation system), received between June 2024 and August 2026; the manufacturer given most often on reports is Zoll Circulation. Spellings of one product vary from report to report.

163 reports arrived in the 12 months to August 2026, up 16% from 140 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (100%); across all system, hypothermia, intravenous, cooling reports (product code NCX) death is recorded in 1% and malfunction in 92.9%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are visual prompts will not clear (68%), unexpected shutdown (3.3%) and failure to power up (3%). The patient problems coded most often are cardiac arrest. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury0%0

Malfunction100%331

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%331

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 4,407 reports carrying product code NCX. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Visual prompts will not clear	225	68%	36.4%
Unexpected shutdown	11	3.3%	1.3%
Failure to power up	10	3%	1.5%
Insufficient heating	8	2.4%	1%
Temperature problem	7	2.1%	1.7%
Insufficient cooling	4	1.2%	1.8%
Leak/splashthe device leaked	4	1.2%	5.5%
No display/image	4	1.2%	0.9%
Display or visual feedback problem	3	0.9%	0.2%
Loose or intermittent connection	3	0.9%	0.1%
Noise, audible	3	0.9%	0.5%
Device emits odor	2	0.6%	0%
Key or button unresponsive/not working	2	0.6%	0%
Breakthe device broke	1	0.3%	0.1%
Detachment of device or device componentpart of the device came off	1	0.3%	0.1%
Electrical /electronic property probleman electrical or electronic problem	1	0.3%	0%
Erratic or intermittent display	1	0.3%	0%
Failure of device to self-test	1	0.3%	0%
High readingsreadings were too high	1	0.3%	0%
Incorrect, inadequate or imprecise result or readings	1	0.3%	0%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
Cardiac arrestthe heart stopped	1	0.3%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Thermogard XP	Product code NCX	All MAUDE reports
Reports	331	4,407	26,136,888
Share of that pool	—	7.5%	0%
Classified as death, per 1,000 reports	0	10	9
Classified as injury	0%	5.9%	36.2%
Classified as malfunction	100%	92.9%	62.3%
Filed by the manufacturer	100%	96.9%	94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code NCX

Brand	Reports	Classified as death
Zoll Ivtm Thermogard Xp	2,238	0.1%
Zoll Ivtm Icy Catheter	429	1.9%
Zoll Ivtm Quattro Catheter	399	4.8%
Zoll Ivtm Solex 7 Catheter	195	2.1%
Invisalign System	534	0%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Thermogard XP reports

How many FDA reports name Thermogard XP?

331 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 163 in the latest 12 months.

What kinds of events are reported?

malfunction (100%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

visual prompts will not clear (68%), unexpected shutdown (3.3%), failure to power up (3%), insufficient heating (2.4%) and temperature problem (2.1%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Thermogard XP was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.