BEUDAMED
    FDA Recall Open, Classified

    Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20

    Recall: Z-1941-2026 · Initiated March 18, 2026

    Recall

    Recall Number
    Z-1941-2026
    Event Number
    98649
    Firm
    Diversatek Healthcare
    FEI Number
    2183446
    Product Code
    KNQ
    Status
    Open, Classified
    Root Cause
    Labeling Change Control
    Initiated
    March 18, 2026
    Posted
    April 23, 2026
    Address
    102 E Keefe Ave, Milwaukee, WI, 53212-1535

    Description

    Diversatek Healthcare Viper 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20

    Reason

    The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.

    Action

    Diversatek Healthcare issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 3/18/2026 via USPS. The notice explained the problem, risk to health, and requested the consignee discard any affected product. Complete and return the attached MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form and provide Signature Confirming Customer Receipt to Laura Boll, VP Regulatory Affairs & Quality at [email protected] or 414-755-4806 to receive a replacement order. For questions about this issue, please contact Laura Boll, Vice President - Regulatory Affairs & Quality, at 414-755-4806 or [email protected].

    Distribution

    US: MO, CA, FL, TX, AZ, PA, RI, NC, IL, MS, KS, NY, OH, VA, LA, IA, MI, NJ, AL, Brazil, Belgium

    Quantity

    1383 units