LeMaitre Over-the-Wire Embolectomy Catheter Recalled for Packaging Sterility Risk
LeMaitre Vascular is recalling 4,315 Over-the-Wire Embolectomy Catheters due to a manufacturing issue that may compromise packaging 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 risk-of-harm product (sterility compromise) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 4,315 units of the LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. The device is indicated for the removal of arterial emboli and thrombi.
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 lot number is OTW3099.
The product was distributed worldwide, including the United States (nationwide and Puerto Rico) and numerous international locations such as Australia, Austria, Belgium, Colombia, Costa Rica, the Czech Republic, Denmark, Egypt, France, Germany, Iceland, Italy, Japan, Jordan, Latvia, Luxembourg, Morocco, the Netherlands, Norway, Oman, Peru, Portugal, Poland, Slovenia, Spain, Switzerland, Sweden, Thailand, the United Kingdom, the United Arab Emirates, and Vietnam. Healthcare providers should stop using the affected devices and contact the manufacturer for instructions.
The recalled product
- Product
- LeMaitre Over-the-Wire Embolectomy Catheter 6F, 80 cm, Model e-1651-68. Indicated for the removal of arterial emboli and thrombi.
- Manufacturer
- LeMaitre Vascular, Inc.
- Category
- Medical Device — Catheter
- Hazard
- 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: OTW3099¿
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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