LeMaitre Vascular Recalls Anastoclip Universal Clip Remover for Mislabeling
LeMaitre Vascular is recalling 20 units of the Anastoclip Universal Clip Remover because marketing materials incorrectly stated the device could be used for dura closure, while it is only intended for cardiovascular use.
What this means for you
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 where marketing materials overstated the intended use of the device. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 20 units of the Anastoclip Universal Clip Remover (REF# e4001-04). The recall involves lot numbers ANR1067 and ANR1073, which were distributed nationwide in the United States.
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.
Healthcare providers and facilities that have received these specific units should stop using them and contact LeMaitre Vascular, Inc. for further instructions regarding the return or disposal of the affected devices.
The recalled product
- Product
- AnastoCiip Universal Clip Remover (1Each} REF# e4001-04 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 access
- Manufacturer
- LeMaitre Vascular, Inc.
- Hazard
- Affected units
- 20
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¿ ANR1073¿
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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