LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Bleeding
LeMaitre Vascular is recalling AlboGraft Knitted with Collagen grafts due to blood blushing or leaking from the graft surface after implantation.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which indicates a reasonable probability that the use of the product will cause serious adverse health consequences or death. The rubric mandates a score of at least 4 for FDA Class I recalls.
Plain-English summary
LeMaitre Vascular, Inc. is recalling two units of AlboGraft Knitted with Collagen, Straight 60x08 (Catalog Number AMC6008). These synthetic vascular grafts are designed to replace sections of damaged or malfunctioning arteries. The specific lot number is 56890A with an expiration date of 2015-04.
The recall was initiated because of blood blushing or leaking from the surface of the graft after implantation. This defect poses a risk of bleeding 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 for instructions on removing or replacing the affected devices.
The recalled product
- Product
- AlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 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
- 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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