510(k) Report

510(k) · Cleared

Recalled · Class I · 2013

Albograft Vascular Prosthesis

K093231510(k) TraditionalCleared Jan 14, 201092-day reviewClass II21 CFR 870.3450Recalls 17 (17 Class I)

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

LeMaitre Vascular, Inc. · MAL Graft, Vascular, Synthetic/Biologic Composite

Cleared on Jan 14, 2010 after a 92-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has a Class I recall. It has been recalled 17 times, including 17 Class I recalls.

Decided
Jan 14, 2010
Review
92 days
Class
Class II
Product code
MAL
Recalls
17 (17 Class I)
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K093231Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

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

DateClassRecallRoot causeReason
Jun 17, 2013Class IZ-1756-2013Process controlBlood blushing/leaking from the surface of the graft after implantation
Jun 17, 2013Class IZ-1762-2013Process controlBlood blushing/leaking from the surface of the graft after implantation
Jun 17, 2013Class IZ-1770-2013Process controlBlood blushing/leaking from the surface of the graft after implantation
Jun 17, 2013Class IZ-1760-2013Process controlBlood blushing/leaking from the surface of the graft after implantation
Jun 17, 2013Class IZ-1765-2013Process controlBlood blushing/leaking from the surface of the graft after implantation
Jun 17, 2013Class IZ-1764-2013Process controlBlood blushing/leaking from the surface of the graft after implantation
Jun 17, 2013Class IZ-1754-2013Process controlBlood blushing/leaking from the surface of the graft after implantation
Jun 17, 2013Class IZ-1757-2013Process controlBlood blushing/leaking from the surface of the graft after implantation
Jun 17, 2013Class IZ-1767-2013Process controlBlood blushing/leaking from the surface of the graft after implantation
Jun 17, 2013Class IZ-1769-2013Process controlBlood blushing/leaking from the surface of the graft after implantation
Jun 17, 2013Class IZ-1766-2013Process controlBlood blushing/leaking from the surface of the graft after implantation
Jun 17, 2013Class IZ-1759-2013Process controlBlood blushing/leaking from the surface of the graft after implantation
Jun 17, 2013Class IZ-1768-2013Process controlBlood blushing/leaking from the surface of the graft after implantation
Jun 17, 2013Class IZ-1755-2013Process controlBlood blushing/leaking from the surface of the graft after implantation
Jun 17, 2013Class IZ-1761-2013Process controlBlood blushing/leaking from the surface of the graft after implantation
Jun 17, 2013Class IZ-1758-2013Process controlBlood blushing/leaking from the surface of the graft after implantation
Jun 17, 2013Class IZ-1763-2013Process controlBlood 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.

How does its category compare?

All MAL devices

MAL Graft, Vascular, Synthetic/Biologic Composite: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · MAL

1in 2012

2010: 12011: 12012: 1
2007high 1 (2010) · low 0 (2007)2026

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

2010: 32021: 12022: 1
2007high 3 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MAL

27in 2025

2007: 142008: 122009: 52010: 72011: 132012: 142013: 342014: 242015: 292016: 202017: 282018: 152019: 282020: 242021: 342022: 212023: 162024: 102025: 27
2007high 34 (2013) · low 5 (2009)2025

MAUDE reports naming product code MAL, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—014
20080—012
20090—05
20101—37
20111—013
20121—014
20130—034
20140—024
20150—029
20160—020
20170—028
20180—015
20190—028
20200—024
20210—134
20220—121
20230—016
20240—010
20250—027
20260—0—

What is it indicated for?

The AlboGraft Double Velour Knitted and Woven Grafts are indicated for use in the replacement or repair of Abdominal and Thoracic arteries affected with aneurysmal or occlusive disease.

Indications for use as stated in the FDA 510(k) statement.

More from LeMaitre Vascular, Inc.

75 FDA decisions under this applicant name. See the company

  • N16837/S040Artegraft Collagen Vascular GraftLeMaitre Vascular, Inc. · 2026
  • N16837/S039Artegraft Collagen Vascular GraftLeMaitre Vascular, Inc. · 2026
  • N16837/S036Artegraft Collagen Vascular GraftLeMaitre Vascular, Inc. · 2025
  • N16837/S035Artegraft Collagen Vascular GraftLeMaitre Vascular, Inc. · 2024
  • N16837/S034Artegraft Collagen Vascular GraftLeMaitre Vascular, Inc. · 2024

Recent decisions in MAL

The MAL category page

  • K122612Hemashield Woven Double Velour Vascular Graft Model M00202175XXXXX; M00202166XXXXXMaquet Cardiovascular, LLC · 2012
  • K103080Albograft Vascular ProsthesisLeMaitre Vascular, Inc. · 201117 Class I recalls
  • K052302Hemashield Platinum Woven Double Velour Taaa Graft ConfigurationBoston Scientific Corp · 20053 recalls
  • K021213Modification to Hemashield Platinum Woven/Microvel Double Velour Vascular GraftsBoston Scientific Corp · 200220 recalls
  • K954848Hemashield Microvel Velour Knitted Vascular GraftMeadox Medicals, Div. Boston Scientific Corp. · 19966 recalls

https://510kreport.com/device/K093231 · printed Nov 6, 2026

Cite this page

510(k) Report. “K093231: 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/K093231

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026