Abbott Vascular recalls MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product…

Recall date

February 4, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0911-2016

FDA classification

Class I

Brand / firm

Abbott Vascular

Sold / distributed

Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Argentina Luxembourg Australia Malaysia Austria Mexico Belgium Netherlands Brazil New Zealand Canada Norway Colombia Philippines Corrientes Poland Czech Republic Portugal Denmark Egypt Romania Finland Saudi Arabia Fra…

Why it was recalled

Abbott Vascular has recently received reports of cases on Clip Delivery System devices that contain the One-Way Actuator Knob where a user attempted implanting a MitraClip, but the Clip could not be detached from the delivery system due to a mandrel fracture.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

MitraClip Clip Delivery System, product number MSK0101. The MitraClip System contains the Clip Delivery System, product number CDS0201, GTIN 08717648195914 and the Steerable Guide Catheter, product number SGC0101, GTIN 08717648195921. The MitraClip Clip Delivery System (CDS) consists of three major components: 1) the Delivery Catheter 2) the Steerable Sleeve, and 3) the MitraClip device. The implantable MitraClip device is located at the distal end of the CDS. The CDS is used to advance and manipulate the implantable MitraClip device for proper positioning and placement on the mitral valve leaflets. The Delivery Catheter, which is part of the CDS, is designed to deliver and deploy the MitraClip. The Delivery Catheter extends through the thru-lumen of the Steerable Sleeve.