LeMaitre AnastoClip GC Closure System Recalled for Incorrect Instructions
LeMaitre Vascular is recalling AnastoClip GC Closure Systems because the included instructions listed uses not cleared by the FDA.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (incorrect instructions for use) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
LeMaitre Vascular, Inc. is recalling the AnastoClip GC Closure System, Reference Number 4007-08. This medical device is a closure system designed to penetrate the outer layers of tissue during the forming of an anastomosis or closing of a vessel, with possible intraluminal penetration.
The recall was initiated because the wrong instructions for use (IFU) were supplied with the devices. The provided IFU listed indications that are not cleared by the FDA for devices distributed in the United States, specifically: 1) closure of arteriotomies and veinotomies, 2) attachment of synthetic vascular prostheses, and 3) approximation of dural tissue.
The affected units were distributed to accounts in Florida, Nevada, Oklahoma, South Carolina, and Texas. The specific lot code for the recalled product is AGC2134. Healthcare providers and facilities should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the outer layers of tissue during the forming of an anastomosis or closing of a vessel with possible intraluminal penetration.
- Manufacturer
- LeMaitre Vascular, Inc.
- Hazard
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)
- AGC2134
Distribution
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