510(k) · Cleared
Recalled · Class I · 2013Albograft Vascular Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
LeMaitre Vascular, Inc. · MAL Graft, Vascular, Synthetic/Biologic Composite
Cleared on Jan 19, 2011 as substantially equivalent to K954848 (Meadox Medicals, Div. Boston Scientific Corp., 1996) after a 92-day review. Its family tree reaches back 2 generations to 1989. 1 of the 3 devices in its family, counting itself, has a Class I recall. It has been recalled 17 times, including 17 Class I recalls.
- Decided
- Jan 19, 2011
- Review
- 92 days
- Class
- Class II
- Product code
- MAL
- Recalls
- 17 (17 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to P840029 (1989). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backP840029 Microvel (R) with HemashieldMaquet Cardiovascular, LLC · 1989
- 1 generation backK954848 Hemashield Microvel Velour Knitted Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 1996 · Recalled
- This deviceK103080 Albograft Vascular ProsthesisLeMaitre Vascular, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P840029 | Microvel (R) with Hemashield | Maquet Cardiovascular, LLC | 1989 | — |
| −1 | K954848 | Hemashield Microvel Velour Knitted Vascular Graft | Meadox Medicals, Div. Boston Scientific Corp. | 1996 | 6 |
| 0 (this device) | K103080 | Albograft Vascular Prosthesis | LeMaitre Vascular, Inc. | 2011 | — |
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 |
|---|---|---|---|
| * | K954848 | Hemashield Microvel Velour Knitted Vascular GraftSummary page 1…Vascular Prosthesis Classification Name: Graft. vascular, svnthetic/biolonic composite Predicate Device: Hemashield Woven Double Velour Vascular Graft (K954848) 1)evice IDescription: Albograft Vascular Prosthesis is a knitted/woven tubular polyester fabric, imp… | 1996 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 17, 2013 | Class I | Z-1756-2013 | Process control | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Class I | Z-1762-2013 | Process control | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Class I | Z-1770-2013 | Process control | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Class I | Z-1760-2013 | Process control | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Class I | Z-1765-2013 | Process control | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Class I | Z-1764-2013 | Process control | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Class I | Z-1754-2013 | Process control | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Class I | Z-1757-2013 | Process control | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Class I | Z-1767-2013 | Process control | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Class I | Z-1769-2013 | Process control | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Class I | Z-1766-2013 | Process control | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Class I | Z-1759-2013 | Process control | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Class I | Z-1768-2013 | Process control | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Class I | Z-1755-2013 | Process control | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Class I | Z-1761-2013 | Process control | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Class I | Z-1758-2013 | Process control | Blood blushing/leaking from the surface of the graft after implantation |
| Jun 17, 2013 | Class I | Z-1763-2013 | Process control | Blood blushing/leaking from the surface of the graft after implantation |
The 5 latest of 17 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 15.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K954848.
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. 2011, this device’s year, is highlighted.
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 AlboGraft Double Velour Knitted or Woven Vascular Prosthesis (peripheral indication) are indicated for use in the replacement or repair of arteries affected with aneurismal or occlusive disease.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103080 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103080: Albograft Vascular Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103080
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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