Events

Recall of Device Recall MitraClip Clip Delivery System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Abbott Vascular.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73243
  • Event Risk Class
    Class 1
  • Event Number
    Z-0911-2016
  • Event Initiated Date
    2016-02-04
  • Event Date Posted
    2016-03-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143617
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Mitral valve repair devices - Product Code NKM
  • 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.
  • 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.

Device

Device Recall MitraClip Clip Delivery System
  • Model / Serial
    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
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • 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.
  • Product Description
    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.
  • Manufacturer
    Abbott Vascular

Manufacturer

Abbott Vascular
  • Manufacturer Address
    Abbott Vascular, 26531 Ynez Rd, Temecula CA 92591-4630
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA