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Class I Recall: Vascular Solutions Langston V2 Dual Lumen Catheters ‏

Jul 8, 2014

The U.S. Food and Drug Administration (FDA) just announced that Vascular Solutions’ recall of its Langston V2 Dual Lumen Catheters (Models 5540 and 5550) has been deemed a Class I recall. A Class I Recall designation is the regulator’s most serious recall type and involves situations in which there exists a reasonable probability that use of the recalled product will cause serious adverse health consequences or death.

The Langston V2 Dual Lumen Pressure Monitoring Catheter recall was implemented on May 27, 2014 after the firm learned that the inner catheter may separate during use and cause injury. The recalled devices were manufactured from January 2014 to April 2014 and distributed from March 2014 to May 2014. Vascular Solutions received reports that the inner catheter of some of its Langston V2 Dual Lumen Catheters separated from the device hub during use. This separation may require a procedure to retrieve the separated piece from the patient’s vascular system. To date, no patient injuries have been reported.

The Langston V2 Dual Lumen Pressure Monitoring Catheter is used to deliver dye, also known as “contrast medium,” into a patient’s blood vessels during medical imaging tests, such as angiographic studies. This enables clinicians to see internal body structures. The device also measures pressure within the blood vessel.

On May 23, 2014, Vascular Solutions sent an "Urgent Medical Device Removal" letter to its customers. The letter advised customers to remove the recalled devices and place them in a secure area, and to complete and return the "VSI Account Inventory Form" included with the letter. Returned devices will be replaced by Vascular Solutions.

Lot numbers for the recalled devices 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

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