BEUDAMED
    FDA Recall Open, Classified

    Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only

    Recall: Z-1043-2022 · Initiated March 23, 2022

    Recall

    Recall Number
    Z-1043-2022
    Event Number
    89935
    Firm
    Medtronic Vascular, Inc.
    FEI Number
    3001452571
    Product Code
    PRC
    Status
    Open, Classified
    Root Cause
    Packaging process control
    Initiated
    March 23, 2022
    Address
    3576 Unocal Pl, Santa Rosa, CA, 95403-1774

    Description

    Medtronic IN.PACT AV, Paclitaxel-coated PTA Balloon Catheter, REF: IAV06008008P, Sterile EO, Rx Only

    Reason

    Packaging for Balloon Catheters may be damaged resulting in loss of sterility.

    Action

    On March 23, 2022 Medtronic issued a "Urgent: Medical Device Recall" notification to affected consignees. In addition to informing consignees about the recalled product, Medtronic ask consignees to take the following actions: 1. Identify and quarantine all unused affected IN.PACT Admiral and IN.PACT AV catheters as listed in Table 1. 2. Return all unused affected product in your inventory to Medtronic. Contact Medtronic Vascular Customer Service at 800-716-6700 to initiate a product return. Your local Medtronic Representative can assist you with the initiation of the return. 3. Please complete the enclosed Customer Confirmation Form and email to [email protected]. 4. This notice should be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please maintain a copy of this notice in your records.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, PUERTO RICO, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Canary Islands, Chile, Colombia, Croatia Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Republic Of Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Caledonia, New Zealand, Norway, Oman, Peru, Philippines, Poland, Portugal, Puerto Rico, Reunion, Russian Federation, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom.

    Quantity

    3 units