The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-1756-2013·Announced 2013-07-31

LeMaitre Recalls Albo Graft Vascular Implants Due to Surface Leaking

LeMaitre Vascular is recalling 7 units of Albo Graft Knitted with Collagen, Bifurcate 16x08 due to blood blushing or leaking from the graft surface after implantation.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The source metadata explicitly identifies the agency classification as 'Class I'. According to the severity rubric, an FDA Class I recall mandates a score of 5 (Critical), as it indicates a reasonable probability of serious adverse health consequences or death.

Plain-English summary

LeMaitre Vascular, Inc. is recalling 7 units of Albo Graft Knitted with Collagen, Bifurcate 16x08 (Catalog Number: AMC1608). These synthetic vascular grafts are designed to replace sections of damaged or malfunctioning arteries. The recall is due to reports of blood blushing or leaking from the surface of the graft after implantation.

The affected units are from lot number 56890A with an expiration date of 2015-04. The products were distributed worldwide, including in the United States (specifically Pennsylvania) and in Brazil, Bulgaria, France, Georgia, Germany, Greece, Italy, Lebanon, the Netherlands, Poland, Spain, and Turkey.

Healthcare providers and patients should contact LeMaitre Vascular for instructions on how to proceed with the recall. This recall is classified as Class I by the FDA, indicating a reasonable probability that the use of, or exposure to, the violative product will cause serious adverse health consequences or death.

The recalled product

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.
Manufacturer
LeMaitre Vascular, Inc.
Category
Medical Device — Vascular Graft
Hazard
Affected units
7

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot number/Expiration Date 56890A 2015-04

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 17 recalled by LeMaitre Vascular, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →

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