510(k) · Cleared
Recalled · Class II · 2020Modification to Hemashield Platinum Woven/Microvel Double Velour Vascular Grafts
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · MAL Graft, Vascular, Synthetic/Biologic Composite
Cleared on Apr 19, 2002 after a 2-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 20 times.
- Decided
- Apr 19, 2002
- Review
- 2 days
- Class
- Class II
- Product code
- MAL
- Recalls
- 20
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK021213 Modification to Hemashield Platinum Woven/Microvel Double Velour…Boston Scientific Corp · 2002
- Descendant · cites it directly · 0 of its ownK070323 Temporary Limb Salvage ShuntVascutek, Ltd. · 2007
Most influential descendants
Showing 1 of 1 · See all- K070323Temporary Limb Salvage ShuntVascutek, Ltd. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021213 | Modification to Hemashield Platinum Woven/Microvel Double Velour Vascular Grafts | Boston Scientific Corp | 2002 | — |
| +1 | K070323 | Temporary Limb Salvage Shunt | Vascutek, Ltd. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MAL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Hemashield Gold grafts Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070323 | Temporary Limb Salvage Shunt | 2007 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 7, 2020 | Class II | Z-1864-2020 | Process design | 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 | Process design | 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 | Process design | 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 | Process design | 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 | Process design | 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 | Process design | 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 | Process design | 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 | Process design | 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 | Process design | 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 | Process design | 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 | Process design | 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 | Process design | 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 | Process design | 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 | Process design | 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 | Process design | 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 | Process design | 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 | Process design | 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 | Process design | 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 | Under Investigation by firm | 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 of 16 x 9 mm is likely incorrectly… |
| May 24, 2010 | Not classified | Z-2063-2010 | Package design/selection | 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 compromise patient safety. |
The 5 latest of 20 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K070323 (Vascutek, Ltd., 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MAL devicesMAL Graft, Vascular, Synthetic/Biologic Composite: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MAL
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · MAL
Too few MAL 510(k)s in any year since 2007 to give a median.
Recalls per year · MAL
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAL
27in 2025
MAUDE reports naming product code MAL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 14 |
| 2008 | 0 | — | 0 | 12 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 1 | — | 3 | 7 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 1 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 34 |
| 2014 | 0 | — | 0 | 24 |
| 2015 | 0 | — | 0 | 29 |
| 2016 | 0 | — | 0 | 20 |
| 2017 | 0 | — | 0 | 28 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 0 | 28 |
| 2020 | 0 | — | 0 | 24 |
| 2021 | 0 | — | 1 | 34 |
| 2022 | 0 | — | 1 | 21 |
| 2023 | 0 | — | 0 | 16 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 27 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021213 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021213: Modification to Hemashield Platinum Woven/Microvel Double Velour Vascular Grafts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021213
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026