Devices › Extracorporeal system for long-term respiratory / cardiopulmonary failure
Device brand name · Extracorporeal system for long-term respiratory / cardiopulmonary failure
XLUNG Kit 230: medical device reports filed with FDA
308 reports name it, 2020–2026. Manufacturer given most often on reports: Xenios. Product code QJZ.
- 308
- device reports naming the brand
- 0% of all MAUDE reports · about 52 a year
- 58
- reports, 12 months to August 2026
- 93 in the 12 months before
- 89.3%
- classified as malfunction
- 86.5% across the product code
- 3.2%
- classified as death, as reported
- 10 reports · not verified by FDA
308 medical device reports received by FDA name the brand "XLUNG Kit 230" (extracorporeal system for long-term respiratory / cardiopulmonary failure); the manufacturer given most often on reports is Xenios; received from August 2020 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
58 reports arrived in the 12 months to August 2026, down 38% from 93 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 (89.3%), injury (7.5%) and death (3.2%); across all extracorporeal system for long-term respiratory / cardiopulmonary failure reports (product code QJZ) death is recorded in 5.5% and malfunction in 86.5%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are fluid/blood leak (53.6%), mechanical problem (19.8%) and leak/splash (19.5%). The patient problems coded most often are hemorrhage/blood loss/bleeding, no patient involvement and hemolysis. 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
Who filed the report
Grey bar: all 512 reports carrying product code QJZ. 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 |
|---|---|---|---|
| Fluid/blood leak | 165 | 53.6% | 35.9% |
| Mechanical problema mechanical problem | 61 | 19.8% | 13.1% |
| Leak/splashthe device leaked | 60 | 19.5% | 12.7% |
| Output problem | 53 | 17.2% | 15% |
| Insufficient device problem information | 52 | 16.9% | 19.5% |
| Incorrect, inadequate or imprecise result or readings | 51 | 16.6% | 14.5% |
| Infusion or flow problema problem with flow or infusion | 7 | 2.3% | 2% |
| Improper flow or infusion | 5 | 1.6% | 1.2% |
| Air/gas in device | 4 | 1.3% | 1% |
| Defective component | 4 | 1.3% | 0.8% |
| Material integrity problema problem with the device material | 4 | 1.3% | 2% |
| Contamination | 3 | 1% | 0.4% |
| Contamination /decontamination problem | 3 | 1% | 0.4% |
| Crackthe device cracked | 3 | 1% | 1.4% |
| Insufficient flow or under infusion | 3 | 1% | 0.6% |
| Device contaminated during manufacture or shipping | 2 | 0.6% | 0.4% |
| Melted | 2 | 0.6% | 0.4% |
| No flow | 2 | 0.6% | 0.8% |
| Obstruction of flow | 2 | 0.6% | 2.3% |
| Pressure problem | 2 | 0.6% | 0.4% |
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 |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 75 | 24.4% |
| No patient involvement | 12 | 3.9% |
| Hemolysis | 11 | 3.6% |
| Low oxygen saturation | 11 | 3.6% |
| Cardiac arrestthe heart stopped | 8 | 2.6% |
| Hematuria | 3 | 1% |
| Hemolytic anemia | 2 | 0.6% |
| Myocardial infarctionheart attack | 2 | 0.6% |
| Thrombosis/thrombus | 2 | 0.6% |
| Viral infectiona viral infection | 2 | 0.6% |
| Abnormal blood gases | 1 | 0.3% |
| Anemialow red blood cells | 1 | 0.3% |
| Blood loss | 1 | 0.3% |
| Cardiogenic shockshock from the heart failing to pump | 1 | 0.3% |
| Cardiopulmonary arrest | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | XLUNG Kit 230 | Product code QJZ | All MAUDE reports |
|---|---|---|---|
| Reports | 308 | 512 | 26,136,888 |
| Share of that pool | — | 60.2% | 0% |
| Classified as death, per 1,000 reports | 32 | 55 | 9 |
| Classified as injury | 7.5% | 8% | 36.2% |
| Classified as malfunction | 89.3% | 86.5% | 62.3% |
| Filed by the manufacturer | 99.7% | 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."
Questions about XLUNG Kit 230 reports
How many FDA reports name XLUNG Kit 230?
308 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 58 in the latest 12 months.
What kinds of events are reported?
malfunction (89.3%), injury (7.5%) and death (3.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
fluid/blood leak (53.6%), mechanical problem (19.8%), leak/splash (19.5%), output problem (17.2%) and insufficient device problem information (16.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%) and distributor reports (0.3%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that XLUNG Kit 230 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.