Z-0391-2019Class I

TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve...

Name: Z-0391-2019 TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve...
Creator: Oscor, Inc.
Published: 2018-09-26
License: https://open.fda.gov/license/

Oscor Inc. / initiated 2018-09-26 / Terminated / root cause: design

FDA source

Oscor, Inc. began a recall of 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... on 2018-09-26. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0391-2019
Classification: Class I
Status: Terminated
Initiated: 2018-09-26
Posted: 2018-11-08
Terminated: 2022-08-04
Recalling firm: Oscor Inc.
Product: 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.
Product code: LDF Electrode, Pacemaker, Temporary
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.
Root cause tag: design
FDA root cause: Device Design
Action: A press release for the recall was issued on 09/27/2018. Additionally, starting on about 09/26/2018, Oscor notified customers via email and mail with a "PRODUCT RECALL - ACTION REQUIRED" letter. For distributors, instructions included to examine inventory for affected devices, quarantine any affected devices, notify customers if the affected devices have been further distributed, retrieve those affected devices from customers, and complete and return the attached Exhibit A. Any affected devices on hand and at customers should not be destroyed, but returned to Oscor. For hospitals, instructions included to examine inventory for affected devices, quarantine any affected devices, and complete and return the attached Exhibit A. Any affected devices on hand and at customers should not be destroyed, but returned to Oscor. Questions can be directed to TB Recall Coordinator at 727-937-2511 or e-mail [email protected]. Oscor business hours are Monday to Friday from 8:30AM to 5:30PM Eastern Time. On 11/07/2018 Oscor expanded the recall and notified customers via "PRODUCT RECALL - ACTION REQUIRED" letter and press release. The expansion includes expired devices distributed by Oscor from 12/21/2011 to 04/30/2015, to result in affected devices distributed from 12/21/2011 to 05/17/2018. Instructions for distributors and hospitals remain the same as the original notification.
Quantity in commerce: 36,688 units
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.
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0391-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0391-2019	Class I	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-08

Product code LDF

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)