# K954848: Hemashield Microvel Velour Knitted Vascular Graft

- Pathway: 510(k) (Traditional)
- Applicant: Meadox Medicals, Div. Boston Scientific Corp.
- Decided: Feb 1, 1996 after 101 days
- Product code: MAL (Graft, Vascular, Synthetic/Biologic Composite)
- Device class: 2
- Regulation: 21 CFR 870.3450
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P840029 (1989). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P840029: Microvel (R) with Hemashield, Maquet Cardiovascular, LLC (1989) Summary page 1.

## Most influential descendants
- K103080: Albograft Vascular Prosthesis (2011), 0 descendants of its own
- K961847: Hemashield Vantage (Vascular Graft (1997), 0 descendants of its own

## Recalls of this device
- Jan 14, 2022 · Class II · Z-0729-2022: Outer labelling (HEMASHIELD GOLD Knitted Microvel Double Velour Bifurcated Vascular Graft, D: 16 x 8 mm; L: 40 cm) does not correspond to the (inner) sterile packaging labelling (HEMASHIELD GOLD Knitt
- Dec 1, 2021 · Class II · Z-0403-2022: There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of th
- Apr 7, 2020 · Class II · Z-1859-2020: Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
- Apr 7, 2020 · Class II · Z-1861-2020: Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
- Apr 7, 2020 · Class II · Z-1860-2020: Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
- May 24, 2010 · Not classified · Z-2066-2010: Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored under proper conditions, which could lead to the prolongation of surgery and potentially com

## Indications for use
For use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.

Source page: https://510kreport.com/device/K954848
Methodology: https://510kreport.com/methodology