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 defect 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 is classified as FDA Class II. The hazard involves compromised sterility of a medical device, which presents a risk of harm (infection) even though specific injuries are not reported in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 4,315 units of the LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm (Model 1654-78 and e1654-78). 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. The specific lot numbers involved are OTW3079 and OTW3046.
Healthcare providers and facilities should stop using the affected devices and contact LeMaitre Vascular for instructions on return or replacement. The FDA has classified this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- LeMaitre Over-the-Wire Embolectomy Catheter 7F, 80cm, Model 1654-78 and e1654-78. 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: OTW3079 OTW3079 OTW3046¿ ¿
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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