CELLEX CLXUSARecalls & reported problems

Summary

The FDA's MAUDE database contains 564 adverse event reports that list this exact device (DI 20705030200003), received between Apr 5, 2016 and Sep 17, 2026 — classified as 1 injury, 563 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (371 reports).

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 16, 2025Open, Classified

   Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a delay in patient treatment and blood loss.

   Z-1822-2026 · Root cause: Process control · FDA record ↗

2. Oct 4, 2021Open, Classified

   Product was released prior to all testing being completed. If used and a drive tube leak were to occur, may cause illness or injury.

   Z-0212-2022 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 564 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Fluid/Blood Leak

  The customer contacted Therakos to report they experienced a Tubing Leak with their CELLEX Photopheresis Kit ("Kit") during an Extracorporeal Photopheresis (ECP) treatment. The customer reported fluid dripping from the AC drip chamber during treatment, after 600mL of whole blood had been processed. The treatment was aborted, and the patient was reported to be stable. The customer returned a video for evaluation.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803854 ↗
• MalfunctionJul 14, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25814165 ↗
• MalfunctionJun 18, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THAT CENTRIFUGE BOWL LEAK/BREAK OCCURRED WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. APPROXIMATELY FIVE MINUTES OF TREATMENT HAD OCCURRED. THE ECP TREATMENT WAS ABORTED, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. NO PICTURES WERE TAKEN, AND THE KIT WAS DISCARDED. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25545548 ↗
• MalfunctionJun 1, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT A PRESSURE DOME LEAK THAT OCCURRED WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. LESS THAN APPROXIMATELY 100 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE ECP TREATMENT WAS ABORTED EARLY, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. THE CUSTOMER ALSO DESCRIBED BLOOD GETTING INTO THE PINHOLE OF THE TRANSDUCER AND INTO THE DECK. THE CUSTOMER HAS NOT RETURNED ANY PRODUCT OR PRODUCT COMPONENTS, NOR ANY PHOTOGRAPHS, FOR EVALUATION. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25347898 ↗
• MalfunctionMay 19, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT AN ALARM #7: BLOOD LEAK (CENTRIFUGE CHAMBER) AND A DRIVE TUBE LEAK/BREAK THAT OCCURRED WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. LESS THAN APPROXIMATELY 1425 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE ECP TREATMENT WAS ABORTED, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. METAL SHAVINGS WERE NOTED IN THE BOTTOM OF THE CENTRIFUGE CHAMBER. THE CUSTOMER HAS DISCARDED THE KIT BUT HAS RETURNED PHOTOGRAPHS FOR EVALUATION. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25216201 ↗
• MalfunctionMay 18, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THAT AN ALARM # 57: RETURN PUMP (#3) ERROR AND A PUMP TUBING ORGANIZER (PTO) LEAK OCCURRED WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. APPROXIMATELY 1050 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE ECP TREATMENT WAS ABORTED, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. TREATMENT WAS STARTING ELUTRIATION WHEN ALARM #57: RETURN PUMP (#3) ERROR OCCURRED. THE CUSTOMER RESET THE ALARM AND NOTED THE PUMP WAS NOT TURNING PROPERLY WHEN THE PUMP TUBING INSIDE THE ORGANIZER BROKE. THE CUSTOMER WAS NOT ABLE TO CLEARLY ARTICULATE WHICH SECTION BROKE. NO PICTURES WERE TAKEN, AND THE KIT WAS DISCARDED. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211879 ↗
• MalfunctionMay 12, 2026Fluid/Blood Leak; Material Twisted/Bent

  THE CUSTOMER CONTACTED THERAKOS TO REPORT AN ALARM #7: BLOOD LEAK (CENTRIFUGE CHAMBER) AND A DRIVE TUBE LEAK/BREAK, BOTH OF WHICH OCCURRED WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. LESS THAN APPROXIMATELY 100 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE ECP TREATMENT WAS ABORTED, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. AFTER OPENING THE CENTRIFUGE CHAMBER DOOR, THE CUSTOMER NOTICED THE TOP OF THE DRIVE TUBE APPEARED TWISTED. THE CUSTOMER MENTIONED NO DIFFICULTIES INSTALLING THE KIT AND REPORTED A FINE MIST OF BLOOD IN A CIRCULAR MOTION ON THE WALL AND BLOOD ON THE CHAMBER CEILING. NO HOLES WERE OBSERVED. THE CUSTOMER HAS RETURNED PHOTOGRAPHS FOR EVALUATION. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153477 ↗
• MalfunctionApr 29, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A CENTRIFUGE BOWL LEAK/BREAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THAT THE BREAK OCCURRED WITH 100 ML OF WHOLE BLOOD HAVING BEEN PROCESSED; THE BOWL SHATTERED AND SEPARATED AT THE CONNECTION SITE TO THE DRIVE TUBE AND THE TOP OF THE BOWL. THE CENTRIFUGE LEAK DETECTOR STRIP WAS ALSO DAMAGED. THE CUSTOMER REPORTED NO DIFFICULTY INSTALLING THE BOWL IN THE BOWL HOLDER, CITING THE BOWL CLICKING INTO PLACE. A VERY SMALL PIECE OF METAL HANGING BY THE UPPER DRIVE TUBE BEARING HAS ALSO BEEN REPORTED. THE TREATMENT WAS ABORTED, AND THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. THE CUSTOMER HAS PROVIDED PHOTOGRAPHS AND HAS RETURNED THE KIT FOR EVALUATION. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25033639 ↗
• MalfunctionApr 28, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A CENTRIFUGE BOWL LEAK/BREAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THAT THE BREAK OCCURRED DURING THE FIRST BUFFY COAT COLLECTION WITH 1450 ML OF WHOLE BLOOD PROCESSED; THE BOWL COMPLETELY SHATTERED AND CAME OUT OF THE HOLDER. THE CENTRIFUGE LEAK DETECTOR STRIP WAS ALSO DAMAGED. THE CUSTOMER HAS PROVIDED PHOTOGRAPHS AND HAS RETURNED THE KIT AND SMART CARD FOR EVALUATION. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE, AND THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25015919 ↗
• MalfunctionApr 15, 2026Coagulation in Device or Device Ingredient

  THE CUSTOMER CONTACTED THERAKOS TO REPORT CLOTS OBSERVED IN THE RETURN LINE WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED ALARM #17: RETURN PRESSURE ALARMS AND OBSERVED BLOOD CLOTTING IN THE RETURN LINE WHEN APPROXIMATELY 1500 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE ECP TREATMENT WAS ABORTED, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887293 ↗
• MalfunctionApr 14, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A CENTRIFUGE BOWL BREAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING THE BUFFY COAT COLLECTION PHASE OF AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED A COLLECT PRESSURE ALARM DUE THE PATIENT MOVEMENT AND THAT THEY WERE ABLE TO RESOLVE THE ALARM. THE CUSTOMER ALSO REPORTED BLOOD SPRAYED UP TO THE CEILING, BUT THERE WAS NO CONCERN OF BLOOD EXPOSURE. THE CUSTOMER IS ALSO UNSURE IF THERE WERE DIFFICULTIES WHEN LOADING THE BOWL. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT. THE CUSTOMER IS RETURNING PHOTOGRAPHS AND THE SUBJECT KIT FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24878517 ↗
• MalfunctionMar 24, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A TUBING LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THAT, AFTER AN ALARM OCCURRED, THEY NOTICED A BLOOD LEAK ON THE PUMP DECK, AROUND THE SENSORS AND INSTRUMENT. THE CUSTOMER WAS UNABLE TO DETERMINE THE ORIGIN OF THE LEAK BUT WAS ABLE TO PROVIDE A PHOTO OF THE PUMP TUBING ORGANIZER (PTO) FOR EVALUATION. THE TREATMENT WAS ABORTED, AND THE PATIENT WAS REPORTED TO BE STABLE. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24682771 ↗
• MalfunctionMar 20, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A CENTRIFUGE BOWL LEAK/BREAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THE CENTRIFUGE BOWL BROKE DURING THE PROCEDURE AFTER 1200 ML OF WHOLE BLOOD WAS PROCESSED. THE CUSTOMER STATED THEY DID NOT HAVE TROUBLE LOADING THE BOWL. THE CUSTOMER ALSO REPORTED THE PATIENT WAS IN STABLE CONDITION. THE KIT WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647814 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A PUMP TUBING ORGANIZER (PTO) LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED A BLOOD LEAK WAS OBSERVED AFTER 1500ML OF WHOLE BLOOD WAS PROCESSED. THE CUSTOMER REPORTED THE BLOOD LEAK WAS OBSERVED AT THE LOCATION OF THE T-CONNECTOR WITHIN THE PTO. THE ECP TREATMENT WAS ABORTED AND NO RESIDUAL BLOOD WITHIN THE KIT WAS RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE CUSTOMER RETURNED THE COMPLAINT KIT FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24563209 ↗
• MalfunctionMar 5, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A CENTRIFUGE BOWL LEAK/BREAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED AN ALARM #7: BLOOD LEAK? (CENTRIFUGE CHAMBER) OCCURRED AND THE BLOOD LEAK/BREAK WAS OBSERVED AFTER 1500ML OF WHOLE BLOOD WAS PROCESSED. THE ECP TREATMENT WAS ABORTED AND NO RESIDUAL BLOOD WITHIN THE KIT WAS RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE CUSTOMER WILL RETURN THE KIT AND PHOTOGRAPHS FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24525598 ↗
• MalfunctionMar 3, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A DRIVE TUBE LEAK/BREAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED A FLUID LEAK WAS OBSERVED FROM THE DRIVE TUBE AFTER 200ML OF WHOLE BLOOD WAS PROCESSED WHEN THE NURSE NOTICED CLEAR FLUID ON THE CENTRIFUGE DOOR WINDOW. THE ECP TREATMENT WAS COMPLETED. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE CUSTOMER WILL RETURN THE KIT AND PHOTOGRAPHS FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24498544 ↗
• MalfunctionMar 3, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A DRIVE TUBE LEAK/BREAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED A BLOOD LEAK WAS OBSERVED FROM THE DRIVE TUBE AFTER 1500MLS OF WHOLE BLOOD WAS PROCESSED. THE BLOOD LEAK WAS OBSERVED AFTER THE TREATMENT WAS COMPLETED AND THE CUSTOMER WAS UNLOADING THE KIT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE CUSTOMER WILL RETURN THE KIT, SMART CARD AND PHOTOGRAPHS FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24497303 ↗
• MalfunctionMar 3, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A DRIVE TUBE LEAK/BREAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED AN ALARM #7: BLOOD LEAK? (CENTRIFUGE CHAMBER) OCCURRED AND A BLOOD LEAK WAS OBSERVED FROM THE DRIVE TUBE AFTER 100MLS OF WHOLE BLOOD WAS PROCESSED. THE ECP TREATMENT WAS ABORTED AND NO RESIDUAL BLOOD WITHIN THE KIT WAS RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE CUSTOMER WILL RETURN THE KIT FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496999 ↗
• MalfunctionMar 3, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A DRIVE TUBE LEAK/BREAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED AN ALARM #7: BLOOD LEAK? (CENTRIFUGE CHAMBER) OCCURRED AND A BLOOD LEAK WAS OBSERVED FROM THE DRIVE TUBE. THE CUSTOMER REPORTED THE BLOOD LEAK APPEARED TO BE COMING FROM THE TOP DRIVE TUBE PORTION NEAR THE BEARING. THE ECP TREATMENT WAS ABORTED AND NO RESIDUAL BLOOD WITHIN THE KIT WAS RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE CUSTOMER WILL RETURN THE KIT AND SMART CARD FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24496284 ↗
• MalfunctionFeb 24, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A CENTRIFUGE BOWL LEAK/BREAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THE CENTRIFUGE BOWL BROKE DURING THE PROCEDURE. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION AND NO RESIDUAL BLOOD WITHIN THE KIT WAS RETURNED TO THE PATIENT. THE KIT RETURN WAS REQUESTED; HOWEVER, THE CUSTOMER DISCARDED THE KIT. THE CUSTOMER WILL RETURN PHOTOGRAPHS FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24435573 ↗
• MalfunctionFeb 18, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A CENTRIFUGE BOWL LEAK/BREAK WITH THEIR CELLEX PHOTOPHERESIS KIT("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THAT THE CENTRIFUGE BOWL BROKE DURING THE TREATMENT AFTER 1500MLS OF WHOLE BLOOD WAS PROCESSED. THE ECP TREATMENT WAS ABORTED AND NO RESIDUAL BLOOD WITHIN THE KIT WAS RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE KIT RETURN WAS REQUESTED; HOWEVER, THE CUSTOMER DISCARDED THE KIT. THE CUSTOMER DID NOT RETURN PRODUCT FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378958 ↗
• MalfunctionFeb 11, 2026Coagulation in Device or Device Ingredient

  THE CUSTOMER CONTACTED THERAKOS TO REPORT BLOOD CLOTTING IN THE RETURN LINE WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED AN ALARM #17: RETURN PRESSURE ALARM OCCURRED, AND THEY OBSERVED BLOOD CLOTS IN THE RETURN LINE AFTER 822 MLS OF WHOLE BLOOD WAS PROCESSED. THE ECP TREATMENT WAS ABORTED AND RESIDUAL BLOOD WITHIN THE KIT WAS NOT RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. NO PRODUCT WAS RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314703 ↗
• MalfunctionJan 28, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A PUMP TUBING ORGANIZER (PTO) LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED A BLOOD LEAK AT THE T-CONNECTION BETWEEN THE RECIRCULATION TUBING LINE AND THE YELLOW TUBING LINE. THE ECP TREATMENT WAS ABORTED AND RESIDUAL BLOOD WITHIN THE KIT WAS NOT RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE CUSTOMER PROVIDED PHOTOGRAPHS FOR EVALUATION AND RETURNED THE COMPLAINT KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24198947 ↗
• MalfunctionJan 19, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A CENTRIFUGE BOWL LEAK/BREAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THE CENTRIFUGE BOWL BROKE DURING THE PROCEDURE. THE ECP TREATMENT WAS ABORTED AND RESIDUAL BLOOD WITHIN THE KIT WAS NOT RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE KIT RETURN WAS REQUESTED; HOWEVER, THE CUSTOMER WILL NOT RETURN THE KIT. THE CUSTOMER RETURNED PHOTOGRAPHS AND THE SMART CARD FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24111176 ↗
• MalfunctionJan 16, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A CENTRIFUGE BOWL LEAK/BREAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") DURING AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THE CENTRIFUGE BOWL BROKE DURING THE PROCEDURE AFTER 1500MLS OF WHOLE BLOOD WAS PROCESSED. THE ECP TREATMENT WAS ABORTED AND RESIDUAL BLOOD WITHIN THE KIT WAS NOT RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS IN STABLE CONDITION. THE KIT WILL BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24100571 ↗