Devices › System, photopheresis, extracorporeal
Device brand name · Xts
Therakos Xts Photopheresis System: medical device reports filed with FDA
189 reports name it, 2012–2016. Manufacturer given most often on reports: Therakos. Product code LNR.
- 189
- device reports naming the brand
- 0% of all MAUDE reports · about 14 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 91.5%
- classified as malfunction
- 86.5% across the product code
- 1.1%
- classified as death, as reported
- 2 reports · not verified by FDA
189 medical device reports received by FDA name the brand "Therakos Xts Photopheresis System" (xts); the manufacturer given most often on reports is Therakos; received from July 2012 to November 2016. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (91.5%), injury (6.9%) and death (1.1%); across all system, photopheresis, extracorporeal reports (product code LNR) death is recorded in 1.2% 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 leak/splash (48.1%), device displays incorrect message (45%) and fluid/blood leak (30.7%). The patient problems coded most often are hemorrhage/blood loss/bleeding, blood loss and low blood pressure/ hypotension. 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
No report naming Therakos Xts Photopheresis System was received in the five years to August 2026; the latest was received in November 2016.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 2,970 reports carrying product code LNR. 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 |
|---|---|---|---|
| Leak/splashthe device leaked | 91 | 48.1% | 26.5% |
| Device displays incorrect message | 85 | 45% | 23.4% |
| Fluid/blood leak | 58 | 30.7% | 43.3% |
| Noise, audible | 14 | 7.4% | 3.2% |
| Device alarm system | 11 | 5.8% | 3.3% |
| Air leak | 10 | 5.3% | 3.2% |
| Breakthe device broke | 7 | 3.7% | 14.3% |
| Device contamination with body fluid | 6 | 3.2% | 2% |
| Device operates differently than expectedthe device behaved unexpectedly | 6 | 3.2% | 2.5% |
| Occlusion within devicethe device blocked | 5 | 2.6% | 1.6% |
| Crackthe device cracked | 4 | 2.1% | 1.8% |
| Device emits odor | 4 | 2.1% | 0.2% |
| Disconnection | 4 | 2.1% | 0.5% |
| Detachment of device component | 2 | 1.1% | 1.7% |
| Improper or incorrect procedure or method | 2 | 1.1% | 0.9% |
| Smoking | 2 | 1.1% | 0.1% |
| Chemical spillage | 1 | 0.5% | 0% |
| Decreased pump speed | 1 | 0.5% | 0% |
| Defective component | 1 | 0.5% | 0.1% |
| Device reprocessing problem | 1 | 0.5% | 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 |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 31 | 16.4% |
| Blood loss | 30 | 15.9% |
| Low blood pressure/ hypotension | 8 | 4.2% |
| Nauseafeeling sick | 4 | 2.1% |
| Test result | 4 | 2.1% |
| Abdominal painstomach or belly pain | 3 | 1.6% |
| Fainting | 3 | 1.6% |
| Deaththe patient died; cause not stated by this term | 2 | 1.1% |
| Diarrhea | 2 | 1.1% |
| Painpain, site not specified | 2 | 1.1% |
| Vomitingbeing sick | 2 | 1.1% |
| Bacterial infectiona bacterial infection | 1 | 0.5% |
| Dehydrationdehydration | 1 | 0.5% |
| Dizzinesslight-headedness or unsteadiness | 1 | 0.5% |
| Exposure to body fluids | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Therakos Xts Photopheresis System | Product code LNR | All MAUDE reports |
|---|---|---|---|
| Reports | 189 | 2,970 | 26,136,888 |
| Share of that pool | — | 6.4% | 0% |
| Classified as death, per 1,000 reports | 11 | 12 | 9 |
| Classified as injury | 6.9% | 10.7% | 36.2% |
| Classified as malfunction | 91.5% | 86.5% | 62.3% |
| Filed by the manufacturer | 100% | 88.7% | 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 LNR
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Cellex Photopheresis System | 1,271 | 101 | 0.6% |
| Therakos Cellex Photopheresis System | 657 | 0 | 1.7% |
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 Therakos Xts Photopheresis System reports
How many FDA reports name Therakos Xts Photopheresis System?
189 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
malfunction (91.5%), injury (6.9%) and death (1.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
leak/splash (48.1%), device displays incorrect message (45%), fluid/blood leak (30.7%), noise, audible (7.4%) and device alarm system (5.8%). 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 Therakos Xts Photopheresis System 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.