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
  • Device Class
  • Implanted device?
  • 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
  • 1 Event


  • Manufacturer Address
    Abbott Vascular, 26531 Ynez Rd, Temecula CA 92591-4630
  • Manufacturer Parent Company (2017)
  • 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