LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling
LeMaitre Vascular is recalling 55 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure.
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 regarding intended use. Per the rubric, minor labeling errors and voluntary precautionary recalls are rated as Moderate (2).
Plain-English summary
LeMaitre Vascular, Inc. is recalling 55 units of the Anastoclip Universal Clip Remover (6 Pack), Reference # e4001-00. The affected units are distributed nationwide in the United States and include lot numbers ANR1067, ANR1072, ANR1073, and ANR1074.
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 discrepancy constitutes a labeling error regarding the intended use of the medical device.
Healthcare providers and facilities that have received these specific lot numbers should stop using the product and contact LeMaitre Vascular for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- AnastoCiip Universal Clip Remover (6 Pack} REF# e4001-00 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: ANR1067¿ ANR1072¿ ANR1073¿ ANR1074¿
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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