510(k) · Cleared
Recalled · Class II · 2022Hemashield Microvel Velour Knitted Vascular Graft
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meadox Medicals, Div. Boston Scientific Corp. · MAL Graft, Vascular, Synthetic/Biologic Composite
Cleared on Feb 1, 1996 as substantially equivalent to P840029 (Maquet Cardiovascular, LLC, 1989) after a 101-day review. Its family tree reaches back 1 generation to 1989. 1 of the 4 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 6 times.
- Decided
- Feb 1, 1996
- Review
- 101 days
- Class
- Class II
- Product code
- MAL
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 1 generation to P840029 (1989). 2 later devices descend from it, 2 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backP840029 Microvel (R) with HemashieldMaquet Cardiovascular, LLC · 1989
- This deviceK954848 Hemashield Microvel Velour Knitted Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1996
- Descendant · cites it directly · 0 of its ownK103080 Albograft Vascular ProsthesisLeMaitre Vascular, Inc. · 2011 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK961847 Hemashield Vantage (Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1997 · Recalled
Class I recalls in this family
- K103080 Albograft Vascular Prosthesiscites it directly · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P840029 | Microvel (R) with Hemashield | Maquet Cardiovascular, LLC | 1989 | — |
| 0 (this device) | K954848 | Hemashield Microvel Velour Knitted Vascular Graft | Meadox Medicals, Div. Boston Scientific Corp. | 1996 | — |
| +1 | K103080 | Albograft Vascular Prosthesis | LeMaitre Vascular, Inc. | 2011 | Class I |
| +1 | K961847 | Hemashield Vantage (Vascular Graft | Meadox Medicals, Div. Boston Scientific Corp. | 1997 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2011 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | P840029 | Microvel (R) with HemashieldSummary page 1…ed Vascular Grafts HEMASHIELD® Woven Double Velour Vascular Grafts HEMASHIELD® CARDIOVASCULAR GRAFTS: HEMASHIELD® Knitted MICROVEL® Double Velour Vascular Grafts (PMA #P840029. approved April 26, 1989) HEMASHIELD® Woven Double Velour Vascular Grafts (PMA #P840029:S5. approved May 11, 1993) The HEMASHIE… | 1989 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 14, 2022 | Class II | Z-0729-2022 | Packaging process control | 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 Knitted Microvel Double Velour Straight… |
| Dec 1, 2021 | Class II | Z-0403-2022 | Labeling Change Control | 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 the carton instead of a Hemashield Gold… |
| Apr 7, 2020 | Class II | Z-1859-2020 | 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-1861-2020 | 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-1860-2020 | 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 |
| May 24, 2010 | Not classified | Z-2066-2010 | 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 6 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K103080Albograft Vascular ProsthesisLeMaitre Vascular, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 117 Class I recalls
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K103080 (LeMaitre Vascular, Inc., 2011) 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?
For use in the replacement or repair of arteries affected with aneurysmal or occlusive disease.
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/K954848 · printed Nov 4, 2026
Cite this page
510(k) Report. “K954848: Hemashield Microvel Velour Knitted Vascular Graft.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K954848
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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