CELLEX CLXCC-IRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00705030000029), received between Oct 30, 2025 and May 6, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Coagulation in Device or Device Ingredient” (2 reports).

8 other recalls cover devices cleared under the same FDA submission (P860003); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 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 ALSO REPORTED ALARM #17: RETURN PRESSURE ALARMS AND OBSERVED BLOOD CLOTTING IN THE RETURN LINE WHEN APPROXIMATELY 355 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE ECP TREATMENT WAS ABORTED, AND RESIDUAL BLOOD WAS NOT RETURNED TO THE PATIENT. NO PRODUCT OR PHOTOGRAPHS WILL BE RETURNED 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 25103703 ↗
• MalfunctionMay 5, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THEY EXPERIENCED A PUMP TUBING ORGANIZER (PTO) LEAK WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") OCCURRING DURING THE BLOOD PRIME PHASES OF AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT. THE CUSTOMER REPORTED THAT THE LEAK APPEARED TO BE COMING FROM THE RETURN RESERVOIR AND THAT THE PATIENT HAD NOT YET BEEN CONNECTED. THE CUSTOMER ALSO REPORTED THAT ALARM #57: RETURN PUMP (#3) ERROR ALSO OCCURRED. THE KIT HAS BEEN DISCARDED, BUT THE CUSTOMER PROVIDED PHOTOGRAPHS FOR EVALUATION. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086205 ↗
• MalfunctionApr 30, 2026Fluid/Blood Leak

  THE CUSTOMER CONTACTED THERAKOS TO REPORT THAT THEY HAD TO ABORT AN EXTRACORPOREAL PHOTOPHERESIS (ECP) TREATMENT WITH THEIR CELLEX PHOTOPHERESIS KIT ("KIT") AFTER A TWO-MINUTE PHOTOACTIVATION AND UNSPECIFIED AIR DETECTED ALARMS. THE CUSTOMER THEN REALIZED THERE WAS A BLOOD LEAK FROM THE PHOTOACTIVATION MODULE. THE CUSTOMER HAS PROVIDED PHOTOGRAPHS FOR EVALUATION. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT, AND THE PATIENT HAS BEEN REPORTED TO HAVE BEEN STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046674 ↗
• MalfunctionOct 30, 2025Coagulation in Device or Device Ingredient; Coagulation 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 THEY OBSERVED CLOTS IN THE KIT AFTER MORE THAN 500 ML OF WHOLE BLOOD HAD BEEN PROCESSED. THE CLOTS WERE OBSERVED IN THE RETURN LINE, CENTRIFUGE BOWL, RETURN BAG, AND FILTER. 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 STATED THEY INJECTED IV CALCIUM INTO THE COLLECT LINE OF THE KIT. THE CUSTOMER STATED THAT THE LIKELY CAUSE OF THE CLOTTING WAS DUE TO THE INJECTION OF IV CALCIUM.THE CUSTOMER WILL RETURN PHOTOGRAPHS AND THE SMART CARD FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23428457 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P860003. One submission often covers many models, so check the product and lot details in each record.

• Z-1822-2026 · May 16, 2025 · Open, Classified
  Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopher
• Z-0567-2022 · Dec 10, 2021 · Open, Classified
  THERAKOS CELLEX Photopheresis Procedural Kit, CLXUSA
• Z-0212-2022 · Oct 4, 2021 · Open, Classified
  THERAKOS CELLEX Photopheresis Procedural Kit PRODUCT CODE: CLXUSA
• Z-1322-2016 · Dec 21, 2015 · Terminated
  The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog CLXUSA. Manufacturing lot D342 UDI: 20705030200003 The system designed to separate the patient's blood i
• Z-0595-2012 · Sep 1, 2011 · Terminated
  Therakos Cellex Photopheresis System CellexUSA & Cellex. The photopheresis system is indicated for use in the ultraviolet-A (UVA) irradiation in the presence of the photoactive dr
• Z-2067-2011 · Feb 1, 2011 · Terminated
  Therakos UVAR XTS Procedural Kits Is indicated for use in the ultraviolet-A (UVA) irradiation.
• Z-2839-2011 · Dec 2, 2010 · Terminated
  Therakos Cellex Procedural Kits. Designed to interface with the Cellex Photopheresis System to perform cell separation and photoactivation in a single, closed and sterile circuit.
• Z-1504-06 · Jul 18, 2006 · Terminated
  Therakos Photopheresis Procedural Kit for use with the UVAR XTS Instrument. (catalog number XT125)