LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk
LeMaitre Vascular is recalling Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise packaging 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 Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. This medical device is indicated for the removal of arterial emboli and thrombi. The recall involves 4,315 units distributed worldwide, including the United States, Puerto Rico, and numerous international locations.
The recall is being issued 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 device. The affected lot numbers are OTW3103, OTW3114, and OTW3119.
Healthcare facilities and distributors should stop using the affected devices and contact LeMaitre Vascular for further instructions. Patients who have received treatment with these devices should consult their healthcare provider if they have concerns regarding sterility or potential infection.
The recalled product
- Product
- LeMaitre Over-the-Wire Embolectomy Catheter 5F Plus, 40 cm, Model e1651-84. Indicated for the removal of arterial emboli and thrombi.
- Manufacturer
- LeMaitre Vascular, Inc.
- 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: OTW3103¿OTW3114¿OTW3119¿ ¿
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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