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.
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 classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Blood blushing/leaking from the surface of the graft after implantation"
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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