Vascular Solutions (NSDQ:VASC) issued a Class I recall for its Langston V2 dual-lumen catheter, due to the risk that the device’s inner catheter can separate.
A Class I recall is the FDA’s highest-risk designation, reserved for devices that could cause serious injury or death.
The affected devices were made from January to April and distributed between March and May. Vascular Solutions received reports that affected lots of the device, which is used to deliver contrast dye during medical imaging tests and to measure intra-vascular pressure, that the inner catheter of some of the devices separated from the device hub during procedures. No injuries or deaths were reported as a result, according to the recall notice.
"This may require a procedure to retrieve the separated piece from the patient’s vascular system," according to the notice.
Vascular Solutions sent an "urgent medical device removal" letter to customers May 23, identifying the problem and the specific products affected. The affected lot numbers are: 569436, 569437, 569962, 569963, 569964, 569965, 570177, 570178, 570337, 570338, 570339, 570340, 570341, 570504, 570505, 570506, 570507, 570592, 570593, 570674, 570675, 570744, 570745, 570746, 570836, 570926, 570927, 570928, 570929, 571099, 571100, 571101, 571102, 571103, 571350, 571412, 571413, 571414, 571415 and 571727.