BEUDAMED
    FDA Enforcement Class I Terminated

    TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.

    Recall: Z-0391-2019 · Reported November 14, 2018

    Enforcement

    Recall Number
    Z-0391-2019
    Event ID
    80984
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Oscor, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 14, 2018
    Initiation Date
    September 26, 2018
    Classification Date
    November 8, 2018
    Termination Date
    August 4, 2022
    Address
    3816 Desoto Blvd, Palm Harbor, FL, 34683-1618, United States

    Description

    TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box.

    Reason

    During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system.

    Code Info

    Item Number (Lot Number): a. TB Lead, 4F Un-Shrouded, Model Number 020004 - 2B-81-532Z-D (OR-03868), 2B-81-532Z-D (OR-03874), 2B-81-532Z-D (C1-06951), 2B-81-532Z-D (C1-06993), 2B-81-532Z-D (C1-06994), 2B-81-532Z-D (C1-07016), 2B-81-532Z-D (C1-07018), 2B-81-532Z-D (C1-07017), 2B-81-532Z-D (D1-02633), 2B-81-532Z-D (D1-02883), 2B-81-532Z-D (DP-01395), 2B-81-532Z-D (OR-04404), 2B-81-532Z-D (C1-09074), 2B-81-532Z-D (C1-09166), 2B-81-532Z-D (DP-02801), 2B-81-532Z-D (DP 02801), 2B-81-532Z-D (DP-04451), 2B-81-532Z-D (DP-05052), 2B-81-532Z-D (DP-05115), 2B-81-532Z-D (DP-05225), 2B-81-532Z-D (DP-05371), 2B-81-532Z-D (DP-05482), 2B-81-532Z-D (DP-05516), 2B-81-532Z-D (DP-05938), 2B-81-532Z-D (DP05968), 2B-81-532Z-D (DP-05976), 2B-81-532Z-D (DP-05998), 2B-81-532Z-D (DP-06062), 2B-81-532Z-D (DP-06098), 2B-81-532Z-D (DP-06203), 2B-81-532Z-D (DP-07789), 2B-81-532Z-D (DP-07840), 2B-81-532Z-D (DP-08130); b. TB LEAD, 5F UN-SHROUDED, Model Number 020005 - 2B-81-532Z-E (D2-01795), 2B-81-532Z-E (C1-06923), 2B-81-532Z-E (C1-06946), 2B-81-532Z-E (C1-06947), 2B-81-532Z-E (C1-06945), 2B-81-532Z-E (C1-06997), 2B-81-532Z-E (C1-06995), 2B-81-532Z-E (C1-06996), 2B-81-532Z-E (C1-07013), 2B-81-532Z-E (C1-07015), 2B-81-532Z-E (C1-07012), 2B-81-532Z-E (C1-07014), 2B-81-532Z-E (D2-01939), 2B-81-532Z-E (D1-02542), 2B-81-532Z-E (D1-02805), 2B-81-532Z-E (DP-01259), 2B-81-532Z-E (DP-01455), 2B-81-532Z-E (DP-01554), 2B-81-532Z-E (OR-04380), 2B-81-532Z-E (C1-08496), 2B-81-532Z-E (C1-08486), 2B-81-532Z-E (C1-08497), 2B-81-532Z-E (C1-08495), 2B-81-532Z-E (OR-04407), 2B-81-532Z-E (C1-08487), 2B-81-532Z-E (C1-08488), 2B-81-532Z-E (C1-08499), 2B-81-532Z-E (C1-08494), 2B-81-532Z-E (C1-08498), 2B-81-532Z-E (C1-08678), 2B-81-532Z-E (C1-08676), 2B-81-532Z-E (C1-08677), 2B-81-532Z-E (C1-08686), 2B-81-532Z-E (C1-08687), 2B-81-532Z-E (C1-08688), 2B-81-532Z-E (C1-08689), 2B-81-532Z-E (C1-08691), 2B-81-532Z-E (C1-08685), 2B-81-532Z-E (C1-08679), 2B-81-532Z-E (C1-08693), 2B-81-532Z-E (C1-08694), 2B-81-532Z-E (DP-02161), 2B-81-532Z-E (C1-08692), 2B-81-532Z-E (C1-09046), 2B-81-532Z-E (C1-09047), 2B-81-532Z-E (C1-09048), 2B-81-532Z-E (C1-09251), 2B-81-532Z-E (C1-09252), 2B-81-532Z-E (C1-09253), 2B-81-532Z-E (DP-02766), 2B-81-532Z-E (DP-02790), 2B-81-532Z-E (DP-02844), 2B-81-532Z-E (DP-03289), 2B-81-532Z-E (DP-03247), 2B-81-532Z-E (DP-03424), 2B-81-532Z-E (DP-04422), 2B-81-532Z-E (DP-04455), 2B-81-532Z-E (DP-04504), 2B-81-532Z-E (DP-04772), 2B-81-532Z-E (DP-04815), 2B-81-532Z-E (DP-04817), 2B-81-532Z-E (DP-04957), 2B-81-532Z-E (DP-05027), 2B-81-532Z-E (DP-05044), 2B-81-532Z-E (DP-05045), 2B-81-532Z-E (DP-05116), 2B-81-532Z-E (DP-05045_1), 2B-81-532Z-E (DP 05116), 2B-81-532Z-E (DP-05274), 2B-81-532Z-E (DP-05417), 2B-81-532Z-E (DP-05543), 2B-81-532Z-E (DP-05686), 2B-81-532Z-E (DP-05687), 2B-81-532Z-E (DP-05958), 2B-81-532Z-E (DP-06080), 2B-81-532Z-E (DP-06060), 2B-81-532Z-E (DP-06141), 2B-81-532Z-E (DP-06206), 2B-81-532Z-E (DP-06346), 2B-81-532Z-E (DP-06535), 2B-81-532Z-E (DP-06762), 2B-81-532Z-E (DP-06568), 2B-81-532Z-E (DP-07015), 2B-81-532Z-E (DP-07018), 2B-81-532Z-E (DP-07017), 2B-81-532Z-E (DP-07146), 2B-81-532Z-E (DP-07262), 2B-81-532Z-E (DP-07438), 2B-81-532Z-E (DP-07500), 2B-81-532Z-E (DP-07642), 2B-81-532Z-E (DP-07787), 2B-81-532Z-E (DP-07643); c. TB LEAD, 6F UN-SHROUDED, 020006 - 2B-81-532Z-F (D2-01775), 2B-81-532Z-F (D2-01691), 2B-81-532Z-F (OR-03853), 2B-81-532Z-F (OR-03961), 2B-81-532Z-F (OR-03878), 2B-81-532Z-F (OR-03939), 2B-81-532Z-F (C1-06953), 2B-81-532Z-F (C1-06954), 2B-81-532Z-F (C1-06955), 2B-81-532Z-F (C1-06956), 2B-81-532Z-F (OR-04060), 2B-81-532Z-F (D1-02562), 2B-81-532Z-F (OR-04100), 2B-81-532Z-F (C1-07081), 2B-81-532Z-F (C1-07082), 2B-81-532Z-F (C1-07079), 2B-81-532Z-F (C1-07080), 2B-81-532Z-F (D1-02806), 2B-81-532Z-F (DP-01003), 2B-81-532Z-F (DP-01004), 2B-81-532Z-F (DP-01214), 2B-81-532Z-F (C1-07955), 2B-81-532Z-F (DP-01082), 2B-81-532Z-F (C1-07945), 2B-81-532Z-F (C1-07946), 2B-81-532Z-F (C1-07958), 2B-81-532Z-F (C1-07964), 2B-81-532Z-F (C1-07956), 2B-81-532Z-F (OR-04278), 2B-81-532Z-F (C1-07966), 2B-81-532Z-F (DP-01569), 2B-81-532Z-F (C1-07957), 2B-81-532Z-F (C1-07959), 2B-81-532Z-F (C1-07960), 2B-81-532Z-F (C1-07961), 2B-81-532Z-F (C1-07962), 2B-81-532Z-F (C1-07963), 2B-81-532Z-F (C1-07965), 2B-81-532Z-F (DP-01374), 2B-81-532Z-F (DP-01492), 2B-81-532Z-F (DP-01553), 2B-81-532Z-F (OR-04329), 2B-81-532Z-F (OR-04330), 2B-81-532Z-F (DP-01601), 2B-81-532Z-F (C1-08396), 2B-81-532Z-F (C1-08407), 2B-81-532Z-F (C1-08410), 2B-81-532Z-F (C1-08409), 2B-81-532Z-F (C1-08411), 2B-81-532Z-F (C1-08412), 2B-81-532Z-F (OR-04367), 2B-81-532Z-F (C1-08398), 2B-81-532Z-F (OR-04408), 2B-81-532Z-F (OR-04369), 2B-81-532Z-F (OR-04399), 2B-81-532Z-F (OR-04368), 2B-81-532Z-F (OR-04366), 2B-81-532Z-F (C1-08670), 2B-81-532Z-F (C1-08666), 2B-81-532Z-F (C1-08667), 2B-81-532Z-F (C1-08668), 2B-81-532Z-F (C1-08669), 2B-81-532Z-F (C1-08674), 2B-81-532Z-F (C1-08675), 2B-81-532Z-F (C1-08704), 2B-81-532Z-F (C1-08705), 2B-81-532Z-F (C1-08706), 2B-81-532Z-F (C1-08711), 2B-81-532Z-F (C1-08718), 2B-81-532Z-F (C1-08720), 2B-81-532Z-F (C1-08709), 2B-81-532Z-F (C1-08735), 2B-81-532Z-F (C1-08732), 2B-81-532Z-F (C1-08710), 2B-81-532Z-F (C1-08714), 2B-81-532Z-F (C1-08717), 2B-81-532Z-F (C1-08716), 2B-81-532Z-F (C1-08721), 2B-81-532Z-F (C1-08719), 2B-81-532Z-F (C1-08703), 2B-81-532Z-F (C1-08707), 2B-81-532Z-F (C1-08708), 2B-81-532Z-F (C1-08733), 2B-81-532Z-F (C1-08734), 2B-81-532Z-F (C1-08731), 2B-81-532Z-F (C1-08715), 2B-81-532Z-F (C1-08671), 2B-81-532Z-F (C1-08713), 2B-81-532Z-F (C1-08680), 2B-81-532Z-F (C1-08755), 2B-81-532Z-F (C1-08681), 2B-81-532Z-F (C1-08683), 2B-81-532Z-F (C1-08701), 2B-81-532Z-F (C1-08723), 2B-81-532Z-F (C1-08672), 2B-81-532Z-F (C1-08673), 2B-81-532Z-F (C1-08682), 2B-81-532Z-F (C1-08702), 2B-81-532Z-F (C1-08712), 2B-81-532Z-F (C1-08722), 2B-81-532Z-F (C1-08724), 2B-81-532Z-F (C1-08753), 2B-81-532Z-F (C1-08754), 2B-81-532Z-F (C1-08756), 2B-81-532Z-F (C1-08757), 2B-81-532Z-F (C1-08759), 2B-81-532Z-F (C1-08760), 2B-81-532Z-F (C1-08761), 2B-81-532Z-F (C1-08762), 2B-81-532Z-F (C1-08763), 2B-81-532Z-F (C1-08758), 2B-81-532Z-F (DP-02162), 2B-81-532Z-F (DP-02793), 2B-81-532Z-F (DP-02932), 2B-81-532Z-F (DP-02942), 2B-81-532Z-F (C1-09444), 2B-81-532Z-F (DP-03114), 2B-81-532Z-F (DP-03116), 2B-81-532Z-F (DP-03117), 2B-81-532Z-F (DP-03118), 2B-81-532Z-F (DP-03115), 2B-81-532Z-F (DP-03144), 2B-81-532Z-F (DP-03123), 2B-81-532Z-F (DP-03229), 2B-81-532Z-F (DP-03323), 2B-81-532Z-F (OR-04667), 2B-81-532Z-F (DP-03893), 2B-81-532Z-F (DP-03930), 2B-81-532Z-F (DP-04378), 2B-81-532Z-F (DP-04377), 2B-81-532Z-F (DP-04386), 2B-81-532Z-F (DP-04454), 2B-81-532Z-F (DP-04456), 2B-81-532Z-F (DP-04707), 2B-81-532Z-F (DP-04760), 2B-81-532Z-F (DP-04818), 2B-81-532Z-F (DP-05108), 2B-81-532Z-F (DP-05362), 2B-81-532Z-F (DP-05349), 2B-81-532Z-F (DP-05350), 2B-81-532Z-F (DP-05416), 2B-81-532Z-F (DP-05510), 2B-81-532Z-F (DP-05544), 2B-81-532Z-F (DP-05559), 2B-81-532Z-F (DP-05511), 2B-81-532Z-F (DP-05599), 2B-81-532Z-F (DP-05630), 2B-81-532Z-F (DP-05637), 2B-81-532Z-F (DP-05685), 2B-81-532Z-F (DP-06005), 2B-81-532Z-F (DP-06052), 2B-81-532Z-F (DP-06388), 2B-81-532Z-F (DP-06495), 2B-81-532Z-F (DP-06496), 2B-81-532Z-F (DP-06497), 2B-81-532Z-F (DP-06498), 2B-81-532Z-F (DP-06500), 2B-81-532Z-F (DP-06546), 2B-81-532Z-F (DP-06501), 2B-81-532Z-F (DP-06567), 2B-81-532Z-F (DP-07049), 2B-81-532Z-F (DP-07134), 2B-81-532Z-F (DP-07513), 2B-81-532Z-F (DP-07784), 2B-81-532Z-F (DP-07785), 2B-81-532Z-F (DP-07790), 2B-81-532Z-F (DP-08166), 2B-81-532Z-F (DP-08167); d. TB LEAD, 4F UN-SHROUDED ATRIAL J-TIP, 020010 - 2B-81-532Z-J (C1-06957), 2B-81-532Z-J (DP-01059), 2B-81-532Z-J (DP-04648); e. TB LEAD, 5F UN-SHROUDED ATRIAL J-TIP, 020011 - 2B-81-532Z-K (C1-06940), 2B-81-532Z-K (D1-02916), 2B-81-532Z-K (D1-02559), 2B-81-532Z-K (OR-04406), 2B-81-532Z-K (DP-04647); f. TB LEAD, 6F UN-SHROUDED ATRIAL J-TIP, 020012 - 2B-81-532Z-L (D1-02565), 2B-81-532Z-L (OR-04370), 2B-81-532Z-L (DP-04649); g. TB LEAD, 4F UN-SHROUDED 60 DEG CURVE, 020016 - 2B-81-532Z-P (C1-06952), 2B-81-532Z-P (DP-01058); h. TB LEAD, 5F UN-SHROUDED 60 DEG CURVE, 020017 - 2B-81-532Z-Q (OR-04416), 2B-81-532Z-Q (DP-03054); i. TB LEAD, 6F UN-SHROUDED 60 DEG CURVE, 020018 - 2B-81-532Z-R (D2-01777), 2B-81-532Z-R (OR-03879), 2B-81-532Z-R (D1-02490), 2B-81-532Z-R (D2-01991), 2B-81-532Z-R (D1-02567), 2B-81-532Z-R (DP-01105), 2B-81-532Z-R (DP-01359), 2B-81-532Z-R (OR-04277), 2B-81-532Z-R (OR-04280), 2B-81-532Z-R (DP-01357), 2B-81-532Z-R (DP-01490), 2B-81-532Z-R (OR-04371), 2B-81-532Z-R (OR-04383), 2B-81-532Z-R (DP-06207); j. TB LEAD, 4F UNSHROUDED RIGHT HEART CURVE, 020022 - 2B-81-532Z-V (DP-02185), 2B-81-532Z-V (DP-03321), 2B-81-532Z-V (DP-04708), 2B-81-532Z-V (DP-04709), 2B-81-532Z-V (DP-05354), 2B-81-532Z-V (DP-05415), 2B-81-532Z-V (DP-05414), 2B-81-532Z-V (DP-06061), 2B-81-532Z-V (DP-06760), 2B-81-532Z-V (DP-07891); k. TB LEAD, 5F UN-SHROUDED RIGHT HEART CURVE, 020023 - 2B-81-532Z-W (D1-02822), 2B-81-532Z-W (D1-02817), 2B-81-532Z-W (D1-02924), 2B-81-532Z-W (D1 02817), 2B-81-532Z-W (C1-08091), 2B-81-532Z-W (C1-08096), 2B-81-532Z-W (C1-08098), 2B-81-532Z-W (C1-08095), 2B-81-532Z-W (C1-08097), 2B-81-532Z-W (C1-08133), 2B-81-532Z-W (C1-08134), 2B-81-532Z-W (DP-01116), 2B-81-532Z-W (C1-08135), 2B-81-532Z-W (C1-08101), 2B-81-532Z-W (C1-08121), 2B-81-532Z-W (C1-08124), 2B-81-532Z-W (C1-08123), 2B-81-532Z-W (C1-08128), 2B-81-532Z-W (C1-08137), 2B-81-532Z-W (C1-08099), 2B-81-532Z-W (C1-08103), 2B-81-532Z-W (C1-08104), 2B-81-532Z-W (C1-08106), 2B-81-532Z-W (C1-08112), 2B-81-532Z-W (C1-08113), 2B-81-532Z-W (C1-08114), 2B-81-532Z-W (C1-08115), 2B-81-532Z-W (C1-08117), 2B-81-532Z-W (C1-08118), 2B-81-532Z-W (C1-08120), 2B-81-532Z-W (C1-08126), 2B-81-532Z-W (C1-08127), 2B-81-532Z-W (C1-08136), 2B-81-532Z-W (C1-08092), 2B-81-532Z-W (C1-08100), 2B-81-532Z-W (C1-08105), 2B-81-532Z-W (C1-08107), 2B-81-532Z-W (C1-08108), 2B-81-532Z-W (C1-08109), 2B-81-532Z-W (C1-08110), 2B-81-532Z-W (C1-08119), 2B-81-532Z-W (C1-08129), 2B-81-532Z-W (C1-08130), 2B-81-532Z-W (C1-08131), 2B-81-532Z-W (C1-08132), 2B-81-532Z-W (C1-08093), 2B-81-532Z-W (C1-08094), 2B-81-532Z-W (C1-08102), 2B-81-532Z-W (C1-08111), 2B-81-532Z-W (C1-08122), 2B-81-532Z-W (DP-01372), 2B-81-532Z-W (DP-01434), 2B-81-532Z-W (DP-01596), 2B-81-532Z-W (OR-04381), 2B-81-532Z-W (OR-04382), 2B-81-532Z-W (OR-04405), 2B-81-532Z-W (DP-02792), 2B-81-532Z-W (OR-04579), 2B-81-532Z-W (DP-02933), 2B-81-532Z-W (DP-02940), 2B-81-532Z-W (DP-02949), 2B-81-532Z-W (OR-04600), 2B-81-532Z-W (OR-04625), 2B-81-532Z-W (OR-04609), 2B-81-532Z-W (OR-04709), 2B-81-532Z-W (C1-11368), 2B-81-532Z-W (C1-11369), 2B-81-532Z-W (C1-11370), 2B-81-532Z-W (C1-11371), 2B-81-532Z-W (C1-11374), 2B-81-532Z-W (C1-11375), 2B-81-532Z-W (C1-11376), 2B-81-532Z-W (C1-11377), 2B-81-532Z-W (C1-12452), 2B-81-532Z-W (C1 12452), 2B-81-532Z-W (DP-04710), 2B-81-532Z-W (DP-4763), 2B-81-532Z-W (DP-04778), 2B-81-532Z-W (OR-04842), 2B-81-532Z-W (DP-05418), 2B-81-532Z-W (DP 05418), 2B-81-532Z-W (DP-05899), 2B-81-532Z-W (DP-05967), 2B-81-532Z-W (DP-06761), 2B-81-532Z-W (DP-06985), 2B-81-532Z-W (DP-07012), 2B-81-532Z-W (DP-07791), 2B-81-532Z-W (DP-07792); l. TB LEAD, 6F UN-SHROUDED RIGHT HEART CURVE, 020024 - 2B-81-532Z-X (D2-01776), 2B-81-532Z-X (D2-01793), 2B-81-532Z-X (D1-02749), 2B-81-532Z-X (OR-04124), 2B-81-532Z-X (D1-02818), 2B-81-532Z-X (DP-01042), 2B-81-532Z-X (DP-01044), 2B-81-532Z-X (DP-01155), 2B-81-532Z-X (OR-04226), 2B-81-532Z-X (DP 01042), 2B-81-532Z-X (C1-07890), 2B-81-532Z-X (C1-07891), 2B-81-532Z-X (C1-07892), 2B-81-532Z-X (C1-07893), 2B-81-532Z-X (C1-07894), 2B-81-532Z-X (C1-07896), 2B-81-532Z-X (C1-07897), 2B-81-532Z-X (C1-07918), 2B-81-532Z-X (C1-07919), 2B-81-532Z-X (C1-07920), 2B-81-532Z-X (C1-07921), 2B-81-532Z-X (C1-07922), 2B-81-532Z-X (C1-07923), 2B-81-532Z-X (C1-07924), 2B-81-532Z-X (C1-07925), 2B-81-532Z-X (C1-07926), 2B-81-532Z-X (C1-07927), 2B-81-532Z-X (C1-07928), 2B-81-532Z-X (C1-07929), 2B-81-532Z-X (C1-07930), 2B-81-532Z-X (C1-07931), 2B-81-532Z-X (C1-07932), 2B-81-532Z-X (C1-07933), 2B-81-532Z-X (C1-07934), 2B-81-532Z-X (C1-07935), 2B-81-532Z-X (C1-07936), 2B-81-532Z-X (C1-07937), 2B-81-532Z-X (C1-07938), 2B-81-532Z-X (C1-07898), 2B-81-532Z-X (C2-07889), 2B-81-532Z-X (C1-07895), 2B-81-532Z-X (OR-04274), 2B-81-532Z-X (C1-07943), 2B-81-532Z-X (C1-07944), 2B-81-532Z-X (DP-01438), 2B-81-532Z-X (DP-01375), 2B-81-532Z-X (OR-04325), 2B-81-532Z-X (DP-01573), 2B-81-532Z-X (DP-01597), 2B-81-532Z-X (DP-01584), 2B-81-532Z-X (DP-01677), 2B-81-532Z-X (DP-01683), 2B-81-532Z-X (OR-04376), 2B-81-532Z-X (OR-04378), 2B-81-532Z-X (OR-04375), 2B-81-532Z-X (OR-04379), 2B-81-532Z-X (OR-04374), 2B-81-532Z-X (C1-08600), 2B-81-532Z-X (C1-08654), 2B-81-532Z-X (C1-08599), 2B-81-532Z-X (C1-08653), 2B-81-532Z-X (OR-04377), 2B-81-532Z-X (C1-08630), 2B-81-532Z-X (C1-08626), 2B-81-532Z-X (C1-08617), 2B-81-532Z-X (C1-08618), 2B-81-532Z-X (C1-08629), 2B-81-532Z-X (C1-08622), 2B-81-532Z-X (C1-08631), 2B-81-532Z-X (OR-04401), 2B-81-532Z-X (C1-08624), 2B-81-532Z-X (C1-08623), 2B-81-532Z-X (C1-08628), 2B-81-532Z-X (C1-08625), 2B-81-532Z-X (C1-08602), 2B-81-532Z-X (C1-08615), 2B-81-532Z-X (C1-08614), 2B-81-532Z-X (C1-08613), 2B-81-532Z-X (C1-08616), 2B-81-532Z-X (C1-08627), 2B-81-532Z-X (DP-03426), 2B-81-532Z-X (DP-03441), 2B-81-532Z-X (DP-03541), 2B-81-532Z-X (DP-03720), 2B-81-532Z-X (DP-04691), 2B-81-532Z-X (DP 04691), 2B-81-532Z-X (DP-04711), 2B-81-532Z-X (DP-04712), 2B-81-532Z-X (DP-04814), 2B-81-532Z-X (DP-04820), 2B-81-532Z-X (DP-05266), 2B-81-532Z-X (DP-05452), 2B-81-532Z-X (DP-05509), 2B-81-532Z-X (DP-05790), 2B-81-532Z-X (DP-05792), 2B-81-532Z-X (DP-05878), 2B-81-532Z-X (DP-05837), 2B-81-532Z-X (DP-05890), 2B-81-532Z-X (DP-05915), 2B-81-532Z-X (DP-05517), 2B-81-532Z-X (DP-05891), 2B-81-532Z-X (DP-07985); m. TB LEAD 4F UNSHROUDED CONVENIENCE KIT, TBK04110USG - 3H-81-003Z-A (DP-03329); n. TB LEAD 5F UNSHROUDED CONVENIENCE KIT, TBK05110USG - 3H-81-005Z-A (DP-01161), 3H-81-005Z-A (DP-02004), 3H-81-005Z-A (DP-02009), 3H-81-005Z-A (DP-02435), 3H-81-005Z-A (DP-02884), 3H-81-005Z-A (DP02884), 3H-81-005Z-A (DP 02884), 3H-81-005Z-A (DP-07032); o. TB 6F U CONVENIENCE KIT ADELANTE SIGMA PLUS 6F S10CM D15CM, TBK06110USG - 3H-81-007Z-A (D1-02232), 3H-81-007Z-A (D1-02520), 3H-81-007Z-A (D1-02833), 3H-81-007Z-A (DP-01376), 3H-81-007Z-A (DP-02083), 3H-81-007Z-A (DP-02408), 3H-81-007Z-A (DP-02885), 3H-81-007Z-A (DP-03724), 3H-81-007Z-A (DP-04453), 3H-81-007Z-A (DP-05047), 3H-81-007Z-A (DP-06146), 3H-81-007Z-A (DP-06147), 3H-81-007Z-A (OR-04888), 3H-81-007Z-A (DP-07005), 3H-81-007Z-A (DOR05934); p. TBRH 4F RT HEART CURVE U CONV. KIT ADELANTE SIGMA PLUS 4F S10CM D15CM, TBRHK04110USG - 3H-81-043Z-A (DP-03330), 3H-81-043Z-A (DP-04258); q. TBRH 5F RT HEART CURVE U CONV. KIT ADELANTE SIGMA PLUS 5F S10CM D15CM, TBRHK05110USG - 3H-81-041Z-A (DP-03051); r. TBRH 6F RT HEART CURVE U CONV. KIT ADELANTE SIGMA PLUS 6F S10CM D15CM, TBRHK06110USG - 3H-81-034Z-A (FP-054291), 3H-81-034Z-A (FP-54291), 3H-81-034Z-A (C1-08813), 3H-81-034Z-A (DP-02166); s. TBV 4F 60 DEGREE U CONV. KIT ADELANTE SIGMA PLUS 4F S10CM D15CM, TBVK04110USG - 3H-81-045Z-A (DP-03397); t. TBJ 4F ATRIAL J CURVE U CONV. KIT ADELANTE SIGMA PLUS 4F S10CM D15CM, TBJK04110USG - 3H-81-047Z-A (DP-03396); u. TBV 6F 60 DEGREE U CONV. KIT ADELANTE SIGMA PLUS 6F S10CM D15CM, TBVK06110USG - 3H-81-035Z-A (FP-55411)

    Distribution

    Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, FL, HI, IN, KS, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PR, RI, TN, TX, UT, VA, WA. Countries of AUSTRIA, BENIN REPUBLIC, BOLIVIA, BRAZIL, BULGARIA, CANADA, COLOMBIA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, GEORGIA, GERMANY, GREECE, GUATEMALA, INDIA, IRAN, IRAN, ISRAEL, ITALY, JORDAN, KAZAKHSTAN, KUWAIT, LATVIA, LEBANON, MACEDONIA, MAURITIUS, MEXICO, NEW ZEALAND, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, RUSSIA, SAUDI ARABIA, SENEGAL, SOUTH AFRICA, TAIWAN, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM.

    Quantity

    36,688 units