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# Safety Alert on Therakos Cellex Photopheresis System
- URL: https://www.fdaweb.com/safety-alert-on-therakos-cellex-photopheresis-system/
- Published: 2018-02-05T12:00:00.000Z
- Updated: 2026-09-14T23:19:39.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140680

A 2/5 FDA [safety alert](https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm595147.htm?ref=fdaweb.com) warns healthcare providers about reports of venous thromboembolism, including pulmonary embolism (PE), in patients who received autologous immune cell therapy using Therakos, Inc.’s Cellex Photopheresis System. “The onset of these events typically occurred during, or shortly after, active treatment sessions,” the alert says.

Since 2012, FDA says it has received seven reports of patients experiencing PE during, or soon after, treatment. “Two of these reports were associated with the death of the patient, although the link between the PE and death cannot be made with certainty,” it says.

The extracorporeal photopheresis device is approved for use in the ultraviolet-A irradiation of extracorporeally circulating leukocyte-enriched blood in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment. It uses methoxsalen as a photosensitizing agent and heparin as a anticoagulant agent. Although approved for CTCL, FDA says, the system is also used as part of clinical practice in treating patients with graft versus host disease, which is resistant to standard immunosuppressive drug treatment, and in patients with acute cardiac allograft rejection which is resistant to standard immunosuppressive drug therapy.