LeMaitre Vascular Recalls Anastoclip AC Clips Due to Mislabeling
LeMaitre Vascular is recalling 256 units of Anastoclip AC Clips because marketing materials incorrectly stated they 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 minor labeling error regarding intended use, with no reported injuries or illnesses.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 256 units of Anastoclip AC 8cm 35 Clips (Medium, REF # 4000-06). The recall is due to a labeling error in the US marketing brochure for the AnastoClip AC Closure System. The brochure incorrectly stated that the specific catalog numbers for these clips could be used for dura closure, whereas the catalog numbers are only intended for cardiovascular use.
The affected units were distributed nationwide in the United States. The recall involves specific lot numbers: ANC1532, ANC1577, ANC1643, ANC1647, ANC1673, ANC2007, ANC2025, ANC2027, ANC2031, ANC2032, and ANC2037. The product consists of a rotating shaft and an integral cartridge containing titanium clips, along with a universal clip remover accessory.
Healthcare providers and consumers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled description. The recall is classified as Class II by the FDA, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Anastoclip AC 8cm 35 Clips (1 Each} Medium REF # 4000-06 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
- Affected units
- 256
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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