LeMaitre Vascular recalled one unit of its Collagen Vascular Graft on September 25, 2025. The device was packed in the wrong size labeled outer packaging, posing a high hazard to patients. Health providers and patients should stop using this device immediately and follow the recall instructions.
The device was incorrectly packed in the wrong size labeled outer packaging.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact LeMaitre Vascular, Inc. or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the Artegraft Collagen Vascular Graft, REF: AG1015. The device is part of a UDI-DI with the number 00316837000343. It was distributed only in Arkansas.
The device's incorrect packing in the wrong size labeled outer packaging poses a significant risk to patients. Mislabeling can lead to improper usage, which may result in serious complications.
No specific incidents or injuries have been reported regarding this recall. The risk level remains high due to potential patient harm from using the incorrectly sized graft.
Stop using the Artegraft Collagen Vascular Graft immediately. Contact LeMaitre Vascular, Inc. or your healthcare provider for further instructions and potential returns.
For more information, contact LeMaitre Vascular at the number provided in the recall letter or visit their website.
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