BEUDAMED
    FDA Enforcement Class II Ongoing

    Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5. M0062251240, 6. M0062251260, 7. M0062251290, 8. M0062251300, 9. M0062251310. 10. M0062251350, 11. M0062251360, 12. M0062251370. (Urology)

    Recall: Z-2536-2025 · Reported September 17, 2025

    Enforcement

    Recall Number
    Z-2536-2025
    Event ID
    97396
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 17, 2025
    Initiation Date
    August 5, 2025
    Classification Date
    September 5, 2025
    Address
    1 Scimed Pl, N/A, Maple Grove, MN, 55311-1565, United States

    Description

    Boston Scientific UroMax Ultra Kit, Material Numbers (UPN): 1. M0062251200, 2. M0062251210, 3. M0062251220, 4. M0062251230, 5. M0062251240, 6. M0062251260, 7. M0062251290, 8. M0062251300, 9. M0062251310. 10. M0062251350, 11. M0062251360, 12. M0062251370. (Urology)

    Reason

    The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.

    Code Info

    1. M0062251200, GTIN 8714729341277, Lot Numbers: 35536688, 35538633, 35538634, 35543803, 35543804, 35572728, 35678100; 2. M0062251210, GTIN 8714729341284, Lot Numbers: 35274797, 35274799, 35277223, 35277224, 35294475, 35294476, 35584203, 35584215, 35656798, 35667482, 35667483; 3. M0062251220, GTIN 8714729341291, Lot Numbers: 35257438, 35535450, 35536202, 35547680, 35656799; 4. M0062251230, GTIN 8714729341307, Lot Numbers: 35266389, 35543805; 5. M0062251240, GTIN 8714729341314, Lot Numbers: 35690647; 6. M0062251260, GTIN 8714729341338, Lot Numbers: 35537838, 35537839. 7. M0062251290, GTIN 08714729341369, Lot Numbers: 35266391; 8. M0062251300, GTIN 08714729341376, Lot Numbers: 35275806, 35536992; 9. M0062251310, GTIN 08714729341383, Lot Numbers: 35536991; 10. M0062251350, GTIN 08714729341390, Lot Numbers: 35690648; 11. M0062251360, GTIN 08714729302421, Lot Numbers: 35257611, 35536990; 12. M0062251370, GTIN 08714729302438, Lot Numbers: 35294477, 35536689.

    Distribution

    Worldwide distribution.

    Quantity

    1369 units