Northeastern Law Faculty Affiliated with the Amy J. Reed Collaborative Petition FDA to Recall all Humacyte Symvess Products

04.10.25—A lab-grown blood vessel developed by the biotech company Humacyte should be immediately recalled and the company’s license for the product should be suspended and revoked according to Northeastern Law faculty who head the Amy J. Reed Collaborative for Medical Device Safety (AJRC). Professors David A. Simon and Hooman Noorchashm, who co-direct the AJRC, argue in a petition to the U.S. Department of Health and Human Services that Humacyte has not demonstrated that Symvess is safe and effective for its approved use, that the product presents a health hazard, and that it is not safe and effective for its intended uses or is misbranded with respect to any such use.

In the citizen’s petition, Simon and Noochashm state, “Given the widespread nature of traumatic vascular injury, particularly among U.S. military personnel, firms have been developing novel biological vascular conduits. The aim of these innovations should be to improve the current standard of care in vascular bypass operations for limb salvage—especially in U.S. military personnel—by demonstrating equivalent or superior efficacy to the autologous vein graft. Importantly, however, the innovations will not be particularly helpful unless there is strong evidence that they are equivalent or better than the existing standard of care.”

According to a recent article in The New York Times, the FDA “approved the vessels in December without a public review of the study. Top officials authorized it over the concerns of staff members who said in FDA records that they found the study severely lacking or were alarmed by the dire consequences for patients when the vessels fell apart.”

Noorchashm, an internationally recognized medical device safety expert, said, “We need immediate regulatory action on this inadequately regulated medical device that could adversely affect acutely injured US military personnel, and other American trauma patients, who are in no condition to properly consent to the use of this non-standard biologic-medical device.”

The Amy J. Reed Collaborative for Medical Device Safety, a joint venture of Northeastern Law and Tufts Medical Center, is a pioneering academic and activist initiative focused on advancing medical device safety through increased awareness, fostering collaboration and facilitating resource sharing among patients and industry experts. Its mission is to drive positive change in the field by advocating for safer medical devices and promoting transparency and accountability.