# K021213: Modification to Hemashield Platinum Woven/Microvel Double Velour Vascular Grafts

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Apr 19, 2002 after 2 days
- Product code: MAL (Graft, Vascular, Synthetic/Biologic Composite)
- Device class: 2
- Regulation: 21 CFR 870.3450
- Recalls of this device: 20 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Hemashield Gold grafts: named in the summary without a submission number

## Most influential descendants
- K070323: Temporary Limb Salvage Shunt (2007), 0 descendants of its own

## Recalls of this device
- Apr 7, 2020 · Class II · Z-1864-2020: 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-1881-2020: 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-1877-2020: 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-1880-2020: 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-1879-2020: 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-1870-2020: 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-1876-2020: 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-1873-2020: 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-1875-2020: 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-1866-2020: 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-1868-2020: 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-1882-2020: 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-1867-2020: 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-1865-2020: 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-1871-2020: 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-1874-2020: 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-1878-2020: 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-1869-2020: Potential small holes at the seam lines of Hemashield branches causing intra-operative bleeding at the seam lines of the branches of Hemashield grafts
- Aug 22, 2019 · Class II · Z-2559-2019: Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Bifurcated Graft product with the diameter size 
- May 24, 2010 · Not classified · Z-2063-2010: 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
The Hemashield Platinum vascular grafts are indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.

Source page: https://510kreport.com/device/K021213
Methodology: https://510kreport.com/methodology