BEUDAMED
    FDA Recall Open, Classified

    Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO

    Recall: Z-1095-2022 · Initiated March 30, 2022

    Recall

    Recall Number
    Z-1095-2022
    Event Number
    90002
    Firm
    Abbott Vascular
    FEI Number
    2024168
    Product Code
    DQO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 30, 2022
    Posted
    May 19, 2022
    Address
    26531 Ynez Rd, Temecula, CA, 92591-4630

    Description

    Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO

    Reason

    There is a potential that the proximal marker may separate from the imaging catheter

    Action

    On April 11, 2022, Abbott issued a "Urgent: Medical Device Recall" Notification to all affected consignees. On June 6, 2022, Abbott issued a updated Urgent Medical Device Recall notification to provide new information concerning the recall product. Abbott ask consignees to take the following actions: 1. Immediately stop using devices from affected lots 2. Return all unused affected devices to Abbott (if not already completed per previous communication) 3. Review this updated notification letter 4. Complete and return the provided Effectiveness Check Form 5 Share this notification with relevant personnel in your organization. 6If you have further distributed/transferred the affected products, notify those customers. 7. Report any occurrence of product performance issues or patient adverse event to Abbott. 8. Reports may also be sent to the FDA's MedWatch Adverse Event Reporting program by completing Form FDA 3500 online at www.fda.gov or calling 1-800-FDA-1088 or submit by mail or fax to 1-800-FDA-0178

    Distribution

    US:AL AR AZ CA CO CT DC FL GA HI IA IL IN KS KY MA MD ME MI MN MO MT NC NE NH NJ NM NV NY OH OK OR PA PR RI SC TN TX UT VA VT WA WI, PR OUS: AE, AT, AW, BE, CA, CH, DE, DK, IT, JP, LU, NL, NO, NZ, PL, EE, ES, FI, FR, GB, HK, HU, IE, PT, RO, SE, SG, SI, TH

    Quantity

    14,544 UNITS