UVAR XTSRecalls & reported problems across all models
Therakos LLC · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 105
- Deaths reported
- 1
- Injuries reported
- 4
- Recalls
- 0
We found 3 models of UVAR XTS by Therakos LLC in the FDA's device registry (GUDID). Together they are named in 105 adverse event reports in the FDA's MAUDE database, received between Aug 20, 2015 and Jul 27, 2018 — classified as 1 death, 4 injuries, 100 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (56 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported UVAR XTS problems
Device problems
- Device Displays Incorrect Message56
- Fluid/Blood Leak51
- Leak/Splash34
- Break18
- Air Leak4
- Crack4
- Adverse Event Without Identified Device or Use Problem3
- Detachment Of Device Component3
Patient problems
- No Known Impact Or Consequence To Patient56
- No Consequences Or Impact To Patient21
- Blood Loss10
- Hemorrhage/Blood Loss/Bleeding7
- No Information5
- Fatigue2
- Low Blood Pressure/ Hypotension2
- No Code Available2
UVAR XTS models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- UVAR XTS XT125SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL59 reports
- UVAR XTSSYSTEM, PHOTOPHERESIS, EXTRACORPOREAL1 death43 reports
- UVAR XTS XT001SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL3 reports
Recent UVAR XTS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJul 27, 2018Obstruction of Flow
THE CUSTOMER SENT AN EMAIL TO REPORT A BLOOD CLOT OBSERVED DURING THE TREATMENT PROCEDURE. THE CUSTOMER REPORTED THE CLOTS WERE SEEN IN THE RETURN LINE, TREATMENT BAG AND RETURN BAG. THE CUSTOMER REPORTED THE CLOTS WERE OBSERVED DURING THE SECOND CYCLE OF THE PROCEDURE. THE CUSTOMER REPORTED HEPARIN ANTICOAGULANT WAS USED DURING THE TREATMENT AT A 12:1 RATIO. THE CUSTOMER STATED THEY RECEIVED AN OCCLUSION PATIENT ALARM. THE CUSTOMER REPORTED THE PROCEDURE WAS ABORTED WITH NO RETURN OF BLOOD TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS STABLE. THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7728274 ↗MalfunctionJun 6, 2018Device Displays Incorrect Message
THE CUSTOMER CALLED TO REPORT A SYSTEM ERROR F183 ALARM WAS RECEIVED DURING THE TREATMENT PROCEDURE. THE CUSTOMER STATED THE ALARM WAS RECEIVED BEFORE THE START OF CYCLE 6 OF THE TREATMENT PROCEDURE. THE CUSTOMER STATED THEY OPENED THE CENTRIFUGE CHAMBER TO CHECK FOR LEAKS AND DID NOT SEE ANY. THE CUSTOMER WAS UNABLE TO CLEAR THE ALARM AND ABORTED THE TREATMENT WITHOUT RETURNING BLOOD TO THE PATIENT. THE CUSTOMER STATED THE PATIENT WAS STABLE. THE CUSTOMER HAS RETURNED THE KIT AND DATA KEY FOR INVESTIGATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7576241 ↗MalfunctionMay 11, 2018Break; Fluid/Blood Leak; Device Displays Incorrect Message
THE CUSTOMER SENT AN EMAIL TO REPORT A CENTRIFUGE BOWL LEAK/BREAK DURING THE TREATMENT PROCEDURE. THE CUSTOMER STATED AT THE END OF THE FIRST CYCLE OF THE PROCEDURE THEY RECEIVED A LEAK CENTRIFUGE ALARM. THE CUSTOMER ABORTED THE PROCEDURE AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER STATED THE CENTRIFUGE BOWL HAD NO MOVEMENT BETWEEN THE BASE COMPONENT AND BOWL OUTLET. THE CUSTOMER STATED THE PATIENT WOULD START TREATMENT ON A DIFFERENT INSTRUMENT THAT SAME DAY. THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508822 ↗MalfunctionMay 11, 2018Break; Fluid/Blood Leak; Device Displays Incorrect Message
THE CUSTOMER SENT AN EMAIL TO REPORT A CENTRIFUGE BOWL LEAK/BREAK DURING THE TREATMENT PROCEDURE. THE CUSTOMER STATED AT THE END OF THE FIRST CYCLE OF THE PROCEDURE THEY RECEIVED A LEAK CENTRIFUGE ALARM. THE CUSTOMER ABORTED THE PROCEDURE AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER STATED THE CENTRIFUGE BOWL HAD NO MOVEMENT BETWEEN THE BASE COMPONENT AND BOWL OUTLET. THE CUSTOMER STATED THE PATIENT WOULD START TREATMENT ON A DIFFERENT INSTRUMENT THAT SAME DAY. THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7508708 ↗MalfunctionMay 10, 2018Break; Fluid/Blood Leak; Device Displays Incorrect Message
THE CUSTOMER SENT AN EMAIL TO REPORT A CENTRIFUGE BOWL LEAK/BREAK DURING THE TREATMENT PROCEDURE. THE CUSTOMER INDICATED THAT A LEAK CENTRIFUGE ALARM WAS RECEIVED DURING THE RETURN PHASE OF THE FIRST CYCLE DUE TO A CENTRIFUGE BOWL LEAK. THE CUSTOMER ABORTED THE PROCEDURE AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER HAS RETURNED PHOTOGRAPHS FOR INVESTIGATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7504631 ↗MalfunctionMay 10, 2018Break; Fluid/Blood Leak; Device Displays Incorrect Message
THE CUSTOMER SENT AN EMAIL TO REPORT A CENTRIFUGE BOWL LEAK/BREAK DURING THE TREATMENT PROCEDURE. THE CUSTOMER STATED DURING THE SECOND CYCLE OF THE PROCEDURE THEY RECEIVED A SYSTEM ERROR F431. THE CUSTOMER STATED UPON INSPECTION OF THE CENTRIFUGE CHAMBER THEY OBSERVED PLASMA LEAKING AT THE LEVEL OF THE CENTRIFUGE BOWL OUTLET LINE. THE CUSTOMER ABORTED THE PROCEDURE AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER STATED THE PATIENT WAS STABLE. THE CUSTOMER HAS RETURNED PHOTOGRAPHS FOR INVESTIGATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7504478 ↗MalfunctionApr 18, 2018Break; Leak/Splash; Device Displays Incorrect Message
THE CUSTOMER SENT AN EMAIL TO REPORT A CENTRIFUGE BOWL LEAK/BREAK DURING THE TREATMENT PROCEDURE. THE CUSTOMER STATED THEY RECEIVED A LEAK CENTRIFUGE ALARM AND OPENED THE CENTRIFUGE TO INSPECT FOR LEAKS. THE CUSTOMER STATED THERE WAS A SMALL AMOUNT OF BLOOD AT THE HEAD OF THE CENTRIFUGE BOWL. THE CUSTOMER OBSERVED A LOSS OF MOVEMENT BETWEEN THE FIXED AND ROTATING PART OF THE CENTRIFUGE BOWL. THE CUSTOMER ABORTED THE PROCEDURE AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER HAS RETURNED PHOTOGRAPHS FOR INVESTIGATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7441386 ↗MalfunctionApr 15, 2018Leak/Splash; Device Displays Incorrect Message
ON (B)(6) 2018, THE THERAKOS DISTRIBUTOR SUPPORTING THE COUNTRY OF (B)(6) REPORTED THAT ONE OF THEIR CUSTOMERS EXPERIENCED A CENTRIFUGE BOWL LEAK/BREAK WHILE PERFORMING A PATIENT TREATMENT USING AN XTS DEVICE. THE CUSTOMER CONTACTED THE DISTRIBUTOR ON (B)(6) 2018 TO REPORT THAT THEY EXPERIENCED A BLOOD LEAK ALARM DURING THE EXTRACTION PHASE OF THE TREATMENT. THE CUSTOMER ALSO INDICATED THAT THEY HAD OBSERVED BLOOD LEAKING FROM THE NECK OF THE CENTRIFUGE BOWL UPON INSPECTION OF THE XTS KIT. ACCORDING TO THE DISTRIBUTOR, BLOOD FROM THE DEVICE WAS RETURNED TO THE PATIENT. ALTHOUGH REQUESTED, NO FURTHER INFORMATION REGARDING THE INCIDENT WAS PROVIDED. NO PRODUCT WAS RETURNED FOR EVALUATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7431908 ↗MalfunctionApr 11, 2018Break; Fluid/Blood Leak
THE CUSTOMER SENT AN EMAIL TO REPORT A CENTRIFUGE BOWL LEAK/BREAK DURING THE TREATMENT PROCEDURE. THE CUSTOMER REPORTED A LEAK CENTRIFUGE ALARM WAS RECEIVED AND A LEAK WAS OBSERVED. THE LOCATION OF THE LEAK WAS NOT PROVIDED. THE CUSTOMER ABORTED THE PROCEDURE AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS STABLE. THE CUSTOMER HAS RETURNED PHOTOGRAPHS FOR INVESTIGATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7422571 ↗MalfunctionMar 30, 2018Break; Fluid/Blood Leak; Device Displays Incorrect Message
THE CUSTOMER SENT AN EMAIL TO REPORT A CENTRIFUGE BOWL LEAK/BREAK DURING THE TREATMENT PROCEDURE. THE CUSTOMER REPORTED A LEAK CENTRIFUGE ALARM WAS RECEIVED AND NOTED BLOOD LEAKING FROM THE CENTRIFUGE BOWL. THE CUSTOMER ABORTED THE TREATMENT AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS STABLE. THE CUSTOMER HAS RETURNED PHOTOGRAPHS FOR INVESTIGATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7386449 ↗MalfunctionMar 16, 2018Break; Leak/Splash; Device Displays Incorrect Message
THE CUSTOMER SENT AN EMAIL TO REPORT A CENTRIFUGE BOWL LEAK/BREAK DURING THE TREATMENT PROCEDURE. THE CUSTOMER REPORTED A SYSTEM ERROR F404 WAS RECEIVED DURING TREATMENT AND A LEAK CENTRIFUGE ALARM. THE CUSTOMER OBSERVED A LEAK FROM THE CENTRIFUGE BOWL. THE CUSTOMER ABORTED THE TREATMENT AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS STABLE. THE CUSTOMER HAS RETURNED PHOTOGRAPHS FOR INVESTIGATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7346640 ↗MalfunctionMar 14, 2018Break; Fluid/Blood Leak
THE CUSTOMER REPORTED A CENTRIFUGE BOWL LEAK/ BREAK THAT OCCURRED DURING A PATIENT TREATMENT. A THIN LINE OF BLOOD WAS DISCOVERED INSIDE THE CENTRIFUGE CHAMBER. THE TREATMENT WAS ENDED AND THE PATIENT WAS DISCONNECTED. THE PATIENT WAS IN STABLE CONDITION AND NOT BE AFFECTED BY THE INCIDENT. THE PATIENT WAS TREATED ON A DIFFERENT INSTRUMENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE CUSTOMER WILL NOT BE RETURNING THE PRODUCTS BACK FOR INVESTIGATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7337776 ↗MalfunctionFeb 16, 2018Break; Fluid/Blood Leak; Device Displays Incorrect Message
THE CUSTOMER REPORTED A CENTRIFUGE BOWL LEAK/ BREAK THAT OCCURRED DURING A PATIENT TREATMENT. THE BOWL LEAKAGE WAS OBSERVED DURING THE FIRST CYCLE OF THE PROCEDURE. THE CUSTOMER ALSO STATED THAT A SYSTEM ERROR ALARM #: 571 OCCURRED AND THAT THE BOWL SEAL WAS BROKEN. THE CUSTOMER RETURNED PHOTOGRAPHS OF THE INCIDENT TO BE INVESTIGATED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7278371 ↗MalfunctionFeb 8, 2018Fluid/Blood Leak; Device Displays Incorrect Message
THE CUSTOMER CALLED TO REPORT A BLOOD LEAK ALARM THAT OCCURRED DURING THE 6TH CYCLE OF A PATIENT TREATMENT. THE CUSTOMER STATED THAT THERE WERE NO ALARMS PRIOR TO THE BLOOD LEAK ALARM. THERE WAS NO BLOOD OBSERVED IN THE CENTRIFUGE CHAMBER AND NO BLOOD WAS SEEN LEAKING FROM ANY PART OF THE KIT. THE TREATMENT WAS ABORTED AND THE PATIENT WAS SAID TO BE IN STABLE CONDITION. THE PATIENT WILL BEGIN A NEW PROCEDURE ON A DIFFERENT INSTRUMENT. THE CUSTOMER HAS RETURNED THE KIT BACK FOR INVESTIGATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7251319 ↗MalfunctionFeb 7, 2018Leak/Splash
CUSTOMER CALLED TO REPORT A CENTRIFUGE BOWL LEAK THAT OCCURRED DURING A PATIENT TREATMENT. THE CUSTOMER STATED THAT PRIOR TO THE CENTRIFUGE BOWL LEAK/ BREAK A LEAK CENTRIFUGE ALARM OCCURRED IN CYCLE 4 DURING THE FINAL BUFFY COAT COLLECTION. THE CUSTOMER SAID THEY THEN NOTICED A SLIGHT SPRAY OF BLOOD IN THE CENTRIFUGE CHAMBER. THE CUSTOMER ABORTED THE PROCEDURE WITH NO BLOOD RETURNED BACK TO THE PATIENT. THE PATIENT WAS SAID TO BE IN STABLE CONDITION AND ASYMPTOMATIC. THE CUSTOMER WILL NOT BE RETURNING ANY PRODUCTS BACK FOR INVESTIGATION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7249649 ↗
Other Therakos LLC products
All Therakos LLC devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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