Quick answers
- What is Acellular tissue engineered vessel used for?
- The FDA-approved label (Symvess, Humacyte Global, Inc., December 9, 2025) says: “SYMVESS™ is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Acellular tissue engineered vessel have a boxed warning?
- Yes. The FDA label for Symvess has a boxed warning (“WARNING: GRAFT FAILURE”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Acellular tissue engineered vessel?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Acellular tissue engineered vessel been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Acellular tissue engineered vessel?
- 1 company lists prescription products of Acellular tissue engineered vessel in the FDA NDC Directory, including Humacyte Global, Inc..
What Acellular tissue engineered vessel is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
SYMVESS™ is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible. …
— FDA label: Symvess, Humacyte Global, Inc., effective December 9, 2025. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Its heading: WARNING: GRAFT FAILURE
. Read it on the full label →
Forms and how it is given
| Dosage forms | Implant |
|---|---|
| Route | Intravascular |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Symvess |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Humacyte Global, Inc.1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA125812 | — | Date not on file | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2700346, 2700352 |
|---|---|
| SPL set ID of the quoted label | 15e9e29f-5aa6-4fc6-b0fe-a48cd1473418 |
| FDA labels (SPL) | 1 |
| FDA applications | BLA125812 |
| Active ingredients (FDA) | ACELLULAR TISSUE ENGINEERED VESSEL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Symvess, Humacyte Global, Inc., effective December 9, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →