LeMaitre AlboGraft Vascular Grafts Recalled for Surface Bleeding
LeMaitre Vascular is recalling specific AlboGraft Vascular Grafts 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is Class I, which mandates a minimum score of 4 per the rubric. Additionally, the defect involves a structural failure (leaking) of a vascular implant, which poses a significant risk of injury.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 2 units of AlboGraft Knitted with Collagen, Straight 15x06 (Catalog Number AMC1506). These synthetic vascular grafts are designed to replace sections of damaged or malfunctioning arteries.
The recall was initiated because blood blushing or leaking was observed from the surface of the graft after implantation. The affected units are identified by Lot Number 56890A and 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 further instructions regarding the return or replacement of these devices.
The recalled product
- 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.
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Vascular Grafts
- Affected units
- 2
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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