LeMaitre Vascular, Inc.: Blood blushing/leaking from the surface of the graft after implantation

Agency Publication Date: July 22, 2013

Affected Products

Product: AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Product: AlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Product: Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Product: AlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Product: AlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Product: AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Product: AlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Product: AlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Product: 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.

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Product: AlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Product: AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Product: AlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Product: AlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Product: AlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Product: AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Product: AlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Product: AlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 65553

Status: Resolved

Manufacturer: LeMaitre Vascular, Inc.

Manufactured In: United States

Units Affected: 17 products (1 unit; 2 units; 7 units; 3 units; 1 unit; 3 units; 1 unit; 3 units; 3 units; 2 untis; 2 units; 2 units; 2 units; 1 unit; 1 unit; 2 units; 3 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Lot number/Expiration Date 56890A 2015-04

Lot Numbers:

number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 65553

Status: Resolved

Manufacturer: LeMaitre Vascular, Inc.

Manufactured In: United States

Units Affected: 17 products (1 unit; 2 units; 7 units; 3 units; 1 unit; 3 units; 1 unit; 3 units; 3 units; 2 untis; 2 units; 2 units; 2 units; 1 unit; 1 unit; 2 units; 3 units)