Home / Recalls / Oscor, Inc. / Z-0391-2019

Z-0391-2019 Class I Terminated

Recalled by Oscor, Inc. — Palm Harbor, FL

FDA device recall Z-0391-2019 was initiated by Oscor, Inc. on September 26, 2018 and is designated Class I. Reason for recall: 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, … The recall status is terminated (terminated August 4, 2022). Affected quantity: 36,688 units.

Recall Details

Product Type
Devices
Report Date
November 14, 2018
Initiation Date
September 26, 2018
Termination Date
August 4, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
36,688 units

Product 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 for Recall

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.

Distribution Pattern

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.

Code Information

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)

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FDA data resources