FDA Class I Recall for Vascular Solutions’ Langston V2 Dual Lumen Catheters

Vascular_Solutions_Langston_V2_Dual_Lumen_CathetersMedical device maker Vascular Solutions has recalled lots of the Langston V2 Dual Lumen Catheter because some catheters have separated from the device hub during use. The patient may need a procedure to retrieve the separated piece from the vascular system.

The Langston catheter delivers dye (contrast medium) into a patient’s blood vessels during medical imaging tests that allow clinicians to see internal body structures. The device also measures pressure within the blood vessel, the Food and Drug Administration (FDA) explains.This is categorized as a Class I recall, which is the FDA’s most serious category. In a Class I recall, use of the affected product may cause serious adverse health consequences, including death. Vascular Solutions said that to date there are no reported patient injuries.

Vascular Solutions sent its customers an Urgent Medical Device Removal letter on May 23 to alert them to the problem and identify the specific products affected by the recall. The letter advised customers to remove affected devices from use and keep them in a secure area until they can be returned to the manufacturer. Vascular Solutions will replace all returned devices.

To obtain information about the recall and return procedures, customers should call Vascular Solutions Customer Service at 1.888.240.6001, Monday through Friday, 8:00 a.m. to 5:00 p.m. Central Time or by email at customerservice@vasc.com.

The FDA encourages health care professionals and consumers to report adverse reactions or quality problems with these products to the MedWatch Safety Information and Adverse Event Reporting Program online, by mail, or by fax.

 

 

 

This entry was posted in Defective Medical Devices, Product Recalls, Recalled Medical Devices. Bookmark the permalink.


© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.