LeMaitre Embolectomy Catheter Recalled for Packaging Sterility Risk
LeMaitre Vascular is recalling Single Lumen Embolectomy Catheters due to a manufacturing defect that may compromise packaging sterility.
What this means for you
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 source text describes a potential sterility compromise without reporting any specific illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
LeMaitre Vascular, Inc. is recalling 4,315 units of the LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. These medical devices are indicated for the removal of arterial emboli and thrombi.
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 catheter. The affected lots include SLC3636, SLC3668, SLC3669, SLC3654, and SLC3670.
The products were distributed worldwide, including the United States (nationwide and Puerto Rico) and numerous international locations such as Australia, Austria, Belgium, and the United Kingdom. Healthcare providers and facilities should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- LeMaitre Single Lumen Embolectomy Catheter 4F, 80 cm, Model 1601-48 and e1601-48. Indicated for the removal of arterial emboli and thrombi.
- Manufacturer
- LeMaitre Vascular, Inc.
- Affected units
- 4,315
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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