LeMaitre Vascular (NSDQ:LMAT) recently issued an urgent field safety notice for some of its Syntel Silicone over-the-wire embolectomy catheters.
The Burlington, Massachusetts-based company issued the warning due to the French size next to the outside diameter symbol on the label not reflecting the 5 Fr catheter extrusion used on all models of the Syntel silicone embolectomy catheter.
Patients who receive the catheter are unlikely to be at risk, according to the company. All devices are indicated for use with the same guidewire and compatibility with the accessory device is not challenged.
Device models are A4E02 and A4E08 with serial/lot number ranges of PYT1070 and PYT1042.
LeMaitre Vascular recommends providers identify the device in their inventories and can choose to return the affected device to the company or keep them.
Syntel Silicone over-the-wire embolectomy catheters have a double-lumen catheter body with a silicone balloon on the distal end and two standard luer connectors on the proximal end. One of the lumens is used to inflate balloons and the other is for infusion of fluids or insertion over a guidewire.
The device is indicated for the removal of thromboemboli from the peripheral arterial system, for the occlusion of the vessel and for the infusion of fluids into a vessel. It is contraindicated for endarterectomy procedures or for use in the venous system.