Severity
Critical
FDA Devices recall · Reported July 31, 2013
Blood blushing/leaking from the surface of the graft after implantation
LeMaitre Vascular, Inc. recalled AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 AlboGraft Vas… - a critical-severity action.
AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 AlboGraft Vas… was recalled by LeMaitre Vascular, Inc. in July 31, 2013. Reason: Blood blushing/leaking from the surface of the graft after implantation. Check the official notice for the remedy. Verify recall #Z-1762-2013 with the FDA Devices before acting.
The recall
LeMaitre Vascular, Inc. issued this critical-severity FDA Devices recall-Blood blushing/leaking from the surface of the graft after implantation.
Sourced from official FDA Devices enforcement records. Verify recall #Z-1762-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1762-2013) was formally reported on July 31, 2013, with the manufacturer initiating the action on June 17, 2013. It is classified under Critical severity (Class I), with a current status of Terminated. LeMaitre Vascular, Inc. is listed as the recalling firm, operating out of Burlington, MA. Federal records list the affected scope as 3 units.
The documented reason for this recall is: Blood blushing/leaking from the surface of the graft after implantation Distribution data in the federal record shows the product reached: Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Critical
Affected scope
3 units
Related Recalls
6
3 from same agency
AlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Blood blushing/leaking from the surface of the graft after implantation
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1762-2013 |
| Date reported | July 31, 2013 |
| Date initiated | June 17, 2013 |
| Recalling firm | LeMaitre Vascular, Inc. |
| Firm location | Burlington, MA |
| Affected scope | 3 units |
| Distribution | Worldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 31, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.