LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Bleeding
LeMaitre Vascular is recalling AlboGraft Knitted with Collagen vascular 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 involves a Class I medical device defect (bleeding from a vascular graft) which poses a significant risk of serious injury, meeting the criteria for a Severe rating.
Plain-English summary
LeMaitre Vascular, Inc. is recalling AlboGraft Knitted with Collagen, Straight 40x07 vascular grafts (Catalog Number: AMC4007). These synthetic medical devices 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 from Lot 56890A with an expiration date of 2015-04.
The product was 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 40x07 Catalog Number: AMC4007 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
- 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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