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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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.
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