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Dual Lumen Catheters Labeled Class I Recall by FDA


May 11, 2020

WASHINGTON, D.C. — Vascular Solutions, Inc. has recalled its Langston Dual Lumen Cather devices after receiving negative reports concerning the separation of the inner catheter while in use. Vascular Solutions has received eight complaints to date, reporting the possibility the inner catheter could separate during a medical procedure. As a consequence of the potentially fatal injuries a detached catheter could inflict upon a patient, the U.S. Food and Drug Administration (FDA) labeled the recall as Class I. A Class I FDA recall is the most severe and urgent recall designation employed by the FDA and denotes that continued use of the defective medical device could kill or seriously injure a patient. *

Vascular Solutions distributed the recalled Dual Lumen between mid-July of 2019 and early March of 2020. The recalled devices were assembled from late June to early December of 2019.  In its notice of a recall, Vascular Solution noted that if the inner catheter separated during a medical procedure, the patient could sustain severe health consequences such as requiring additional surgical procedures to remove the broken catheter, damage to the vascular structures where the broken piece is trapped, and death.

The physician using the product is not safe if it failed before insertion into the patient. A broken interior catheter while outside of the patient could soak the doctor with a dye that could cause a severe infection. The doctor would then need to seek treatment. 

Vascular Solutions has not received any complaints of injuries or deaths after any of the eight episodes in which the inside catheter broke. The Dual Lumens device is most often used by physicians to deliver contrasting fluids during the test, as well as taking pressure readings from within blood vessels.

Vascular Solutions' parent company, Teleflex, advised customers to remove all recalled devices from stockpiles. Teleflex will destroy any undistributed devices. 

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Source:

https://www.fda.gov/medical-devices/medical-device-recalls/vascular-solutions-inc-recalls-langston-dual-lumen-catheter-due-risk-separation-during-use

Category: Product Liability

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