LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling
LeMaitre Vascular is recalling the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure, though it is only intended for cardiovascular use.
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, but the source text identifies the issue as a labeling error regarding intended use without reporting any injuries, illnesses, or hospitalizations. This aligns with the 'Moderate' severity criteria for minor labeling errors.
Plain-English summary
LeMaitre Vascular, Inc. is recalling the Anastoclip Universal Clip Remover (6 Pack), Reference # 4001-00. The recall involves 40 units distributed nationwide in the United States. The affected lot numbers are ANR1064, ANR1066, ANR1068, and ANR1069.
The recall was initiated because the US marketing brochure for the AnastoClip AC Closure System incorrectly stated that the Anastoclip catalog numbers could be used for dura closure. The source text clarifies that these catalog numbers are only intended for cardiovascular use. This constitutes a labeling error regarding the intended use of the medical device.
Healthcare providers and consumers should stop using the affected Anastoclip Universal Clip Remover units and contact LeMaitre Vascular, Inc. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- AnastoCiip Universal Clip Remover (6 Pack} REF# 4001-00 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is intended to remove Anastoclip AC Clips as necessary. It is an…
- 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)
- Lot Numbers: ANR1064¿ ANR1066¿ ANR1068¿ ANR1069¿
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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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