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# Recall All Humacyte Symvess Products: Petition
- URL: https://www.fdaweb.com/recall-all-humacyte-symvess-products-petition/
- Published: 2025-04-15T12:00:00.000Z
- Updated: 2026-09-14T15:09:27.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159014

Harmed Americans for Reforms in Medical Device Safety (HARMS) is asking FDA to recall all Humacyte Symvess vascular graft products and withdraw its approval of the Symvess BLA. The 4/10 [petition](https://downloads.regulations.gov/FDA-2025-P-1083-0001/attachment%5F1.pdf?ref=fdaweb.com) cites eight cases with ATEV (acellular tissue-engineered vessel) blowouts or disruptions generally associated with major, life-threatening hemorrhage. It also cites agency medical reviewer concerns about unacceptable risks of infection and anatomic disruption that “is a perilous observation in view of the stated desire of the Department of Defense to use Symvess to treat America’s wounded warriors on the battlefield.”

The petition asks FDA to:

- initiate a recall for Symvess;
- immediately suspend Humacyte’s BLA for Symvess; and
- initiate a revocation of the Symvess BLA.

The petition also calls for an open and public hearing to review the product’s safety and efficacy and says FDA should disclose data it possesses on Symvess to the Department of Defense, which is a major user of the product.

The petition notes that one of its signers, **Robert Lee**, is a vascular surgeon and retired CDRH medical officer who says he raised issues about Symvess when the product’s BLA was being considered by CBER. According to the petition, CBER sought input from CDRH because the graft had characteristics that could render it a medical device under federal law and regulation. Lee was a consulting reviewer on the Symvess BLA, it says, and “concluded that the totality of the trauma data required more stringent and public scrutiny.” Lee and his CDRH colleagues reportedly recommended that the BLA not be approved without first vetting the data in an open advisory panel meeting.

Lee “expressed concern that the trauma clinical data provided by Humacyte to CBER demonstrated a serious lapse in clinical and statistical rigor required to convincingly show the non-inferiority of Symvess to standard synthetic grafts,” the petition says. “In fact, Lee explained to CBER and CDRH leadership that clinical outcomes related to the use of Symvess are significantly inferior to those seen with the use of standard synthetic vascular grafts.”

The advisory committee meeting Lee recommended was not held, the petition says, and the Symvess approval letter says the application was not referred to an advisory committee “because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion.”

The petition says that statement is not true, given that Lee and his CDRH colleagues “did everything possible to bring the concerning Humacyte clinical treatment data to the attention of” former CBER director **Peter Marks** and his management team.

The petition contends that FDA should not have approved the Symvess BLA without an open advisory panel meeting to review the data for this first-in-class vascular graft. “To protect both American citizens and our service members at home and abroad, and to restore public trust in the agency, FDA should take the actions requested,” it concludes. “Although FDA recognized some of the risks discussed in this petition and ordered post-marketing surveillance, that is not sufficient to urgently address the serious risks posed by this product and the shortcomings of the studies Humacyte conducted.”