Langston V2 Dual Lumen Catheters (Models 5540 and 5550) by Vascular Solutions: Class I Recall - Inner Catheter May Separate During Use and Cause Injury

[Posted 07/07/2014]

AUDIENCE: Cardiology, Critical Care Medicine, Risk Manager

ISSUE: Vascular Solutions received reports that the inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub during use. This may require a procedure to retrieve the separated piece from the patient’s vascular system. There are no reported patient injuries.

The use of affected product may cause serious adverse health consequences, including death.

BACKGROUND:  The Langston V2 Dual Lumen Pressure Monitoring Catheter is used to deliver dye (contrast medium) into a patient’s blood vessels during medical imaging tests (angiographic studies) that allow clinicians to see internal body structures. The device also measures pressure within the blood vessel. Affected devices were manufactured from January 2014 to April 2014, and distributed from March 2014 to May 2014. See Recall Notice for affected lot numbers.

RECOMMENDATION: On May 23, 2014, Vascular Solutions sent an "Urgent Medical Device Removal" letter to their customers. The letter advises customers to:

•  Remove affected devices and place them in a secure area.
• Complete and return the "VSI Account Inventory Form" included with the letter.
• Returned devices will be replaced by Vascular Solutions.

Healthcare professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

[07/07/2014 - Recall Notice - FDA]