The FDA on Monday announced a Class I designation for Vascular Solutions’ recall of its Langston V2 Dual Lumen Pressure Monitoring Catheter.
Health practitioners use the device to deliver dye, or contrast medium, into a patient’s blood vessels during medical imaging tests; the device also measures pressure within the blood vessel.
FDA officials think the recalled catheters could cause serious injury or death because Vascular Solutions received reports that the inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub while in use. In such cases, a procedure may be needed to retrieve the separated piece from the patient’s vascular system.
Maple Grove, MN–based Vascular Solutions sent an “Urgent Medical Device Removal” letter to customers on May 23. Affected catheters were manufactured from January 2014 to April 2014, and distributed from March 2014 to May 2014.