Recall Class: Class I
Date Recall Initiated: May 27, 2014
Product: Langston V2 Dual Lumen Pressure Monitoring Catheter
Lot numbers: See Affected Lot Numbers below.
Range of manufacturing and distribution dates: Affected devices were manufactured from January 2014 to April 2014, and distributed from March 2014 to May 2014.
Use: 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.
Vascular Solutions, Inc.
6464 Sycamore Court
Minneapolis, MN 55369
Reason for Recall: 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.
Public Contact: For information, contact Vascular Solutions Customer Service at 1-888-240-6001 Monday through Friday, 8:00 a.m. - 5:00 p.m. Central Time or by email at firstname.lastname@example.org.
FDA District: Minneapolis District Office
More Information about this Recall:
On May 23, 2014, Vascular Solutions sent an "Urgent Medical Device Removal" letter to their customers. The letter identified the problem and the specific products affected by the recall. 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.
Affected Lot numbers:
About Class I Recalls
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.