Recall Z-0911-2016— Abbott Vascular

Class I FDA medical device recall by Abbott Vascular, initiated 2016-02-04, terminated 2016-05-12. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..

Recalling firm

Abbott Vascular

Classification

Class I

Status

Terminated

Initiated

2016-02-04

Terminated

2016-05-12

Firm location

Temecula, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.