LeMaitre AlboGraft Vascular Grafts Recalled for Surface Leaking
LeMaitre Vascular, Inc. is recalling specific AlboGraft vascular grafts because they may leak blood from the surface after being implanted in patients.
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 high-risk medical device with a defect that can cause bleeding (blood blushing/leaking) after implantation. As no specific injuries or fatalities are reported in the source text, it is classified as High (risk-of-harm products where injury has not yet been reported).
Plain-English summary
LeMaitre Vascular, Inc. is recalling AlboGraft Knitted with Collagen, Bifurcate 18x10 vascular grafts (Catalog Number: AMC1810). These synthetic medical devices are designed to replace sections of damaged or malfunctioning arteries. The recall is limited to units with Lot Number 56890A and an expiration date of 2015-04.
The recall was initiated because the grafts may experience blood blushing or leaking from the surface after implantation. This defect poses a risk to patients who have received the device.
The affected units 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, Inc. for instructions on how to proceed with the recall.
The recalled product
- 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.
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Vascular Graft
- Hazard
- Affected units
- 1
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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