LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk
LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters worldwide due to a manufacturing defect that may 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. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity score.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 4,315 units of the LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. The recall is due to a manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
The affected devices were distributed worldwide, including the United States (nationwide and Puerto Rico) and numerous international locations such as Australia, Austria, Belgium, and the United Kingdom. Specific lot numbers involved in the recall include OTW3080, OTW3081, OTW3083, and OTW3100.
Healthcare providers and facilities should check their inventory for these specific lot numbers and stop using the affected devices. The source text does not provide specific instructions for consumers, as these are medical devices intended for professional use.
The recalled product
- Product
- LeMaitre Over-the-Wire Embolectomy Catheter 3F, 80cm, Model 1651-38. 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 Numbers: OTW3080 OTW3080¿ OTW3081¿ OTW3083¿ OTW3100¿
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.
See all 13 products in this recall →Related recalls
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