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U.S. Department of Health and Human Services

Class 1 Device Recall MitraClip Clip Delivery System

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  Class 1 Device Recall MitraClip Clip Delivery System see related information
Date Initiated by Firm February 04, 2016
Date Posted March 07, 2016
Recall Status1 Terminated 3 on May 12, 2016
Recall Number Z-0911-2016
Recall Event ID 73243
PMA Number P100009 
Product Classification Mitral valve repair devices - Product Code NKM
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.

Code Information Lot number  50811U1 50811U2 50812U1 50813U1 50814U1 50826U1 50826U2 50827U1 50908U1 50908U2 50909U1 50910U1 50910U2 50911U1 50924U1 50925U1 50928U1 50929U1 51010U1 51012U1 51012U2 51013U1 51014U1 51014U2 51026U1 51027U3 51028U1 51028U2 51029U1 51030U1 51105U1 51106U1 51109U1 51109U2 51110U1 51110U2 51117U1 51203U1 51204U1 51205U1 51207U1 
Recalling Firm/
Manufacturer
Abbott Vascular
26531 Ynez Rd
Temecula CA 92591-4630
For Additional Information Contact Jim Krater
951-914-2400
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Use error
Action The firm, Abbott Vascular, sent an "URGENT FIELD SAFETY NOTICE/MITRACLIP/CORRECTION" letter dated 2/4/16 to all the customers who received the MitraClip System. The letter described the product, problem and actions to be taken. The Customers are informed that their inventory is acceptable for safe use following the revised IFU steps described in the customer notification letter and that there is no need for the customers to return any product to Abbott Vascular. Customers with questions are instructed to contact their local Abbott Vascular representative.Customers were also instructed complete and return a Training Form/Effectiveness Check via their Abbott Vascular Representative, fax to 1-951-914-5951 or scan and email to AVRegulatoryCompliance@av.abbott.com. The firm is revising the IFU to incorporate the revised procedural steps. A press release dated 2/26/16 will be posted on the firm's website to inform the public that Abbott has initiated a voluntary safety notice regarding the MitraClip Delivery System to reinforce the proper procedures used to operate and deploy the device. Customers with questions or concerns are instructed to contact Abbott Vascular Representative or call Abbott Vascular at (800) 227-9902.
Quantity in Commerce 7,600 units total (2,300 units in US)
Distribution 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 France Slovenia Germany Spain Greece Sweden Hong Kong Switzerland Hungary Thailand Indonesia Turkey Israel United Arab Emirates Italy United Kingdom Kuwait and Vietnam.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = NKM and Original Applicant = ABBOTT VASCULAR INC.
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