LeMaitre AlboGraft Vascular Grafts Recalled for Surface Bleeding
LeMaitre Vascular is recalling 3 units of AlboGraft Knitted with Collagen vascular grafts due to blood blushing or leaking from the graft surface after implantation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect (bleeding) that poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 3 units of AlboGraft Knitted with Collagen, Straight 60x06 vascular grafts (Catalog Number: AMC6006). The recall involves Lot 56890A with an expiration date of 2015-04. These synthetic grafts are designed to replace sections of damaged or malfunctioning arteries.
The recall was initiated because of blood blushing or leaking from the surface of the graft after implantation. The affected units were distributed worldwide, including the United States (specifically Pennsylvania) and Brazil, Bulgaria, France, Georgia, Germany, Greece, Italy, Lebanon, Netherlands, Poland, Spain, and Turkey.
Healthcare providers and patients should contact LeMaitre Vascular, Inc. for further instructions regarding the return or replacement of these specific units.
The recalled product
- 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.
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Vascular Graft
- Hazard
- Affected units
- 3
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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