BEUDAMED
    FDA Recall Terminated

    HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM 1012592 018 HT CONNECT FLEX 300 CM 1012593 018 HT CONNECT 250T 145 CM 1012594 018 HT CONNECT 250T 195 CM 1012595 018 HT CONNECT 250T 300 CM

    Recall: Z-0558-2014 · Initiated November 25, 2013

    Recall

    Recall Number
    Z-0558-2014
    Event Number
    66971
    Firm
    Abbott Vascular, Inc.
    FEI Number
    2024168
    Product Code
    DQX
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    November 25, 2013
    Posted
    December 20, 2013
    Terminated
    July 14, 2014
    Address
    26531 Ynez Rd, Temecula, CA, 92591-4630

    Description

    HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM 1012592 018 HT CONNECT FLEX 300 CM 1012593 018 HT CONNECT 250T 145 CM 1012594 018 HT CONNECT 250T 195 CM 1012595 018 HT CONNECT 250T 300 CM

    Reason

    Abbott Vascular has initiated a recall of the HT Connect Peripheral Guide Wires due to a small number of devices exhibiting partial delamination of the PTFE coating.

    Action

    Abbott Vascular sent an Urgent Device Recall letter dated November A recall communication letter dated November 25, 2013, to all affected customers. The letter informed customers of the problems identified and the actions to be taken. The letter informs the customers of the 9 part numbers and 9 description of the products. Abbott Vascular is instructing the customers that the returned products will be replaced with similar products pending availability. Abbott Vascular has attached a customer response form for customers along with the customer notification letter. For questions regarding this recall call 951-914-2400.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Australia, French Guyana, Macedonia, South Korea, Austria, Germany, Malaysia, Spain, Bahrain, Greece, Martinique, Sweden, Belgium, Hong Kong, Netherlands, Switzerland, Brazil, Indonesia, New Zealand, Taiwan, Bulgaria, Iran, Norway, Thailand, Canada, Iraq, Poland, Turkey, China, Ireland, Portugal, United Arab Emirates, Czech Republic, Italy, Saudi Arabia, United Kingdom, Denmark, Latvia, Singapore, Estonia, Libya, Slovakia, Finland, Lithuania, Slovenia, France, Luxembourg, South Africa.

    Quantity

    54,895 units total (5,356 units in US)