LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Defect
LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that could compromise sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a packaging defect could compromise sterility, posing a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 4,315 units of the LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. The device is indicated for the removal of arterial emboli and thrombi. The recall affects Lot Number OTW3108.
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 device. The affected units were distributed worldwide, including the United States (nationwide including Puerto Rico) and numerous international locations such as Australia, Austria, Belgium, and others.
Healthcare providers and facilities should stop using the affected devices and contact LeMaitre Vascular, Inc. for further instructions. Consumers should not use these medical devices if they have them in their possession.
The recalled product
- Product
- LeMaitre Over-the-Wire Embolectomy Catheter 6F, 40 cm, Model e-1651-64. 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: OTW3108¿
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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