LeMaitre AlboGraft Vascular Grafts Recalled for Post-Implantation Bleeding
LeMaitre Vascular is recalling AlboGraft Woven with Collagen grafts due to blood 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 use of the product will cause serious adverse health consequences or death. The defect involves a structural failure of a vascular implant.
Plain-English summary
LeMaitre Vascular, Inc. is recalling AlboGraft Woven with Collagen, Straight 30x18 (Catalog Number ATC3018) vascular grafts. These synthetic devices are designed to replace sections of damaged or malfunctioning arteries. The recall is limited to Lot 56890A with an expiration date of 2015-04.
The recall was initiated because blood was observed blushing or leaking from the surface of the graft after it was implanted. This defect can compromise the integrity of the vascular repair.
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 further instructions regarding the removal or replacement of these devices.
The recalled product
- Product
- AlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 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
- 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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