LeMaitre Vascular Recalls Anasto AC Closure System for Mislabeling
LeMaitre Vascular is recalling 170 units of the Anasto AC Closure System 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, but the source text identifies the issue as a labeling error (marketing brochure) rather than a physical defect or reported injury, fitting the 'Minor labeling errors' criterion for a Moderate score.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 170 units of the Anasto AC Closure System and Anasto Universal Clip Remover. The recall involves specific lot numbers 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 device's 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 for further instructions regarding the return or replacement of the devices.
The recalled product
- Product
- Anasto AC Closure System and Anasto Universal Clip Remover- Anasto AC 8cm 25 Clips (1 Each} X-Large REF # 4000-08 The Anastoclip Clip applier consists of a rotating shaft and an integral cartridge containing titanium clips. The Anastoclip Universal Clip Remover is…
- Manufacturer
- LeMaitre Vascular, Inc.
- Hazard
- Affected units
- 170
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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