LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk
LeMaitre Vascular is recalling specific embolectomy catheters because a manufacturing defect could compromise sterility.
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 the hazard is a theoretical risk of compromised sterility due to a packaging defect, with no reported illnesses or injuries in the source text.
Plain-English summary
LeMaitre Vascular, Inc. is recalling the LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. The recall involves 4,315 units distributed worldwide, including the United States, Puerto Rico, and numerous international markets.
The recall was initiated due to a manufacturing issue that could cause a pinhole in the formed end of the packaging. This defect may lead to compromised sterility of the medical device. The affected lot numbers are SLC3672, SLC3663, and SLC3667.
Healthcare facilities and distributors should stop using the affected catheters and contact LeMaitre Vascular for instructions on return or replacement. The U.S. Food and Drug Administration has classified this as a Class II recall.
The recalled product
- Product
- LeMaitre Single Lumen Embolectomy Catheter 3F, 80 cm, Model 1601-38 and e1601-38. Indicated for the removal of arterial emboli and thrombi.
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Catheter
- Affected units
- 4,315
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 Number: SLC3672¿SLC3663 SLC3663¿SLC3667¿
Distribution
Part of a larger recall action
This product is one of 13 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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