LeMaitre Vascular Recalls AnastoClip AC Clips Due to Mislabeling
LeMaitre Vascular is recalling 471 units of AnastoClip AC Clips because marketing materials incorrectly suggested 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 labeling error regarding intended use. Per the rubric, minor labeling errors and voluntary precautionary recalls are rated as Moderate.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 471 units of AnastoClip AC 8cm 35 Clips (Large, REF # 4000-07). 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 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 consumers should stop using the affected products and contact LeMaitre Vascular, Inc. for further instructions.
The recalled product
- Product
- AnastoClip AC 8cm 35 Clips (1 Each} Large REF # 4000-07 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
- 471
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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