LDF

NUMED BALLOON PACING CATHETER

Advisory panel: Cardiovascular
Total cleared: 128

Adverse events under product code LDF

product code LDF

Death: 19
Injury: 188
Malfunction: 694
Other: 1
Total: 902

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code LDF

1–100 of 128

K242863 — Bioptimal Bipolar Pacing Catheter Bioptimal International Pte. , Ltd. · 2025-06-15
K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) C.R. Bard, Inc. · 2025-05-15
K241334 — Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter, C.R. Bard, Inc. · 2025-01-31
K241199 — Rotatable Connector (5944RL) Shenzhen Launch Electrical Co., Ltd. · 2025-01-23
K242705 — Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500) Medtronic, Inc. · 2025-01-17
K232261 — TME Temporary Myocardial Electrode Osypka AG · 2024-04-26
K190716 — Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead Medtronic · 2019-08-08
K173923 — Temporary Cardiac Pacing Wire ETHICON, Inc. · 2018-08-02
K171253 — Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead Medtronic · 2017-05-25
K161873 — Pacel Flow Directed Pacing Catheter St Jude Medical · 2016-11-22
K160260 — Tempo Temporary Pacing Lead Biotrace Medical, Inc. · 2016-10-25
K161249 — Streamline 6495 Bipolar Temporary Myocardial Pacing Lead Medtronic · 2016-08-19
K152784 — Pacel Bipolar Pacing Catheters St Jude Medical · 2015-10-22
K152633 — Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe Edwards Lifesciences, LLC · 2015-10-15
K140972 — UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING Medtronic, Inc. · 2014-06-06
K072770 — TEMPORARY PACING LEAD, SERIES TBB, MODEL HELIOS (TM) Oscor, Inc. · 2008-01-22
K042190 — MODEL 6416 TEMPORARY PACING LEAD SYSTEM Medtronic Vascular · 2004-09-07
K040812 — DETECT SURGICAL PACING AND MAPPING TOOL Medtronic Vascular · 2004-09-02
K033858 — TEMPORARY BIPOLAR MYOCARDIAL PACING WIRE European Custom Manufacturing BV · 2004-07-12
K032613 — TEMPORARY TRANSVENOUS PACEMAKER PLACEMENT ASSIST DEVICE Peter M. Rothenberg, M.D. · 2003-11-20
K023174 — DISPOSABLE TEMPORARY PACING WIRE River Medical, Inc. · 2003-06-11
K030556 — STEELEX ELECTRODE SET Aesculap, Inc. · 2003-04-22
K011660 — WECK CARDIAC PACING WIRES Weck Closure Systems · 2001-08-21
K012452 — MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD Medtronic Vascular · 2001-08-14
K012454 — MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD Medtronic Vascular · 2001-08-14
K012458 — MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD Medtronic Vascular · 2001-08-14
K012459 — MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE Medtronic Vascular · 2001-08-14
K012460 — MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD Medtronic Vascular · 2001-08-14
K010099 — ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER Zcv ,Inc. · 2001-02-01
K002603 — ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER Zcv ,Inc. · 2001-01-08
K002481 — ZYNERGY FEATHERPACE TRANSVENOUS BIPOLAR CATHETER, MODEL 04-X-02-3-10-3 Zcv ,Inc. · 2000-12-07
K002687 — ZYNERGY Z4 TRANSVENOUS BIPOLAR PACING CATHETER, MODEL 04-X-02-3-10-3 Zynergy Cardiovascular, Inc. · 2000-11-09
K973360 — MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD Medtronic Vascular · 1998-05-26
K980503 — TEMPORARY CARDIAC PACING WIRE ETHICON, Inc. · 1998-04-10
K971775 — INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 Cardiac Control Systems, Inc. · 1997-12-29
K955829 — SAFPACE SYSTEM B.Braun Medical, Inc. · 1997-11-18
K962833 — HARMAC TEMPORARY PACING CATHETER WITH BALLOON Harmac Medical Products, Inc. · 1997-10-15
K963073 — HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET Harmac Medical Products, Inc. · 1997-08-14
K971165 — INTRODUCER SHEATH AND DILATOR Boston Scientific Corp · 1997-07-23
K963898 — MODEL 6495 BIPOLAR TEMPORARY PACING LEAD Medtronic Vascular · 1997-07-22
K961520 — UNIPOLAR IPG GROUND CABLE, MODEL 5473 Medtronic Vascular · 1996-11-13
K960479 — ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER Arrow Intl., Inc. · 1996-10-17
K955712 — USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING C.R. Bard, Inc. · 1996-10-11
K962467 — RV PACING LEAD Abbott Laboratories · 1996-09-17
K955722 — FLEXON TEMPORARY CARDIAC PACER LEAD Davis & Geck, Inc. · 1996-03-15
K954809 — UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494 Medtronic Vascular · 1995-12-13
K934785 — MULTIPACE Electro-Catheter Corp. · 1995-07-27
K944956 — UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491 The Heart Valve Div. Medtronic Cardiovascular Surg · 1995-07-14
K944957 — TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 Medtronic Blood Systems, Inc. · 1995-07-14
K944966 — UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492 Medtronic Blood Systems, Inc. · 1995-07-14
K934787 — SILICORE SEMI-FLOATER Electro-Catheter Corp. · 1995-02-24
K930069 — BIPOLAR BALLOON PACING CATHETER BY J-LLOYD J-Lloyd Medical, Inc. · 1994-01-28
K924388 — ANGEMED MODEL 4000 QC BIPOLAR TEMP PACING LEAD Angemed, Inc. · 1993-10-21
K924390 — ANGEMED 5000 LEAD ADAPTER Angemed, Inc. · 1993-08-25
K922182 — UNIPOLAR ATRIAL TEMPORARY PACING LEAD, MODEL 6492 Medtronic Vascular · 1992-11-23
K922268 — UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD MOD. 6491 Medtronic Vascular · 1992-11-23
K922269 — UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493 The Heart Valve Div. Medtronic Cardiovascular Surg · 1992-11-23
K923407 — MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES Medtronic Vascular · 1992-10-19
K914185 — PACEL(TM) FLOW DIRECTED PACING CATHETER Daig Corp. · 1992-01-27
K913521 — XEMEX TEMPORARY PACING CATHETER A MODIFIED Zeon Medical Corp. · 1991-12-27
K904868 — XEMEX TEMPORARY PACING CATHETER A Zeon Medical Corp. · 1991-05-16
K902342 — UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #6491 Medtronic Vascular · 1990-10-16
K900982 — E-CLIP Joel Cohen & Esther R. Cohen · 1990-04-19
K895789 — UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490 Medtronic Vascular · 1989-12-07
K890988 — MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE Pace Medical · 1989-08-25
K890794 — DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER Daig Corp. · 1989-06-20
K884866 — TEMP. PACING LEADS W/DEPTH MARKINGS TA-1 AND TB-1 Oscor Medical Corp. · 1989-03-22
K882330 — BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER C.R. Bard, Inc. · 1988-09-06
K882045 — HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK Cordis Leads, Inc. · 1988-07-12
K881356 — EXTERNAL PACEMAKER WIRE DRESSING CHANGE Neal & Assoc., Inc. · 1988-05-19
K875059 — DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE Daig Corp. · 1988-02-12
K874310 — WIRE DRESSING Slocum and Neal, Inc. · 1987-12-23
K872972 — TEMPORARY PACEMAKER ELECTRODE Oscor Medical Corp. · 1987-12-03
K873728 — DEKNATEL TEMPORARY CARDIAC PACING WIRE Deknatel, Inc. · 1987-11-03
K873474 — SUTURELESS TEMPORARY EPICARDIAL PACING LEAD Symbion, Inc. · 1987-10-07
K873716 — ADULT WALKING HEEL PRODUCT NO. 4183-130 Martin Medical · 1987-10-02
K862970 — TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 Medtronic Vascular · 1987-09-25
K864507 — V-PACE(TM) TRANSLUMINAL VENTRICULAR/ MODEL SP5540 Spectramed, Inc. · 1987-03-06
K861403 — TB SERIES BIPOLAR PACING LEADS Oscor Medical Corp. · 1986-06-27
K861409 — SYNCARE TEMPORARY CARDIAC PACING WIRE Gyneco, Inc. · 1986-05-05
K855139 — FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT Davis & Geck, Inc. · 1986-02-26
K853818 — MEDTRONIC MODEL 6405 Medtronic Vascular · 1985-10-11
K851913 — CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA Cordis Corp. · 1985-09-16
K852513 — 115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD C.R. Bard, Inc. · 1985-09-16
K852797 — HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODE Mansfield Scientific, Inc. · 1985-09-16
K851845 — NUMED TEMP. STYLET PACING PAROBE 1318694 NuMED, Inc. · 1985-08-29
K851246 — NUMED BALLOON PACING CATHETER NuMED, Inc. · 1985-04-19
K850622 — OSCOR MEDICAL MODEL TME 64S BIPOLAR TEMP/HEART WIR Oscor Medical Corp. · 1985-04-10
K850324 — ELECATH OPEN TIP BIPOLAR PACING CATHETER Electro-Catheter Corp. · 1985-03-27
K843290 — NUMED BALLOON PACING CATHETER NuMED, Inc. · 1985-01-14
K844003 — ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH Electro-Catheter Corp. · 1984-12-27
K841802 — ELECTRODE CATHETER, ORTHOGONAL TYPE Webster Laboratories, Inc. · 1984-10-18
K843141 — CRITIKON HEPARIN-COATED CARDIOVASCULAR Critikon Company, LLC · 1984-09-04
K834416 — LUMELEC ELECTRODE CATHETER Cordis Corp. · 1984-04-24
K840109 — ELECATH HEPARIN COATED TEMP. PACING Electro-Catheter Corp. · 1984-02-04
K831695 — TEMP. CARDIAC PACING WIRE TME 60/61/65 Oscor, Inc. · 1983-10-20
K831804 — MULTIPOLAR TEMPORARY CARDIAC Oscor, Inc. · 1983-10-20
K832561 — EPCOR MULTIELECTRODE TEMP. PERVENOUS Cordis Corp. · 1983-10-19
K832850 — ELECATH PACEWEDGE DUAL PRESS. BIPOLAR Electro-Catheter Corp. · 1983-10-19
K831645 — TEMP. BIPOLAR EPICARDIAL LEAD Cordic Corp. · 1983-07-26

Data sourced from openFDA. This site is unofficial and independent of the FDA.