Electrode, Pacemaker, Temporary
FDA product code LDF · Class II (moderate risk) · 21 CFR 870.3680 · Cardiovascular
130510(k) clearances
0PMA approvals
15recalls
Manufacturers
- Medtronic Vascular 21
- C.R. Bard, Inc. 8
- Electro-Catheter Corp. 7
- Cordis Corp. 5
- Medtronic, Inc. 5
- ETHICON, Inc. 5
- Oscor Medical Corp. 4
- Oscor, Inc. 4
- NuMED, Inc. 3
- Stanco Medical, Inc. 3
- Daig Corp. 3
- Zcv ,Inc. 3
- Medics Instrument Corp. 2
- Ziehm International, Inc. 2
- The Heart Valve Div. Medtronic Cardiovascular Surg 2
- Angemed, Inc. 2
- Medtronic Blood Systems, Inc. 2
- American Edwards Laboratories 2
- Medical Testing System, Inc. 2
- Edwards Lifesciences, LLC 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252042 | Sync AV II Temporary Pacing CatheterLDF · Traditional | Swift Sync, Inc. | 07/30/2026SE |
| K242863 | Bioptimal Bipolar Pacing CatheterLDF · Traditional | Bioptimal International Pte. , Ltd. | 06/15/2025SE |
| K251186 | Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)LDF · Special | C.R. Bard, Inc. | 05/15/2025SE |
| K241334 | Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes…LDF · Traditional | C.R. Bard, Inc. | 01/31/2025SE |
| K241199 | Rotatable Connector (5944RL)LDF · Traditional | Shenzhen Launch Electrical Co., Ltd. | 01/23/2025SE |
| K242705 | Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary…LDF · Special | Medtronic, Inc. | 01/17/2025SE |
| K232261 | TME Temporary Myocardial ElectrodeLDF · Traditional | Osypka AG | 04/26/2024SE |
| K190716 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar…LDF · Traditional | Medtronic | 08/08/2019SE |
| K173923 | Temporary Cardiac Pacing WireLDF · Traditional | ETHICON, Inc. | 08/02/2018SE |
| K171253 | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar…LDF · Special | Medtronic | 05/25/2017SE |
| K161873 | Pacel Flow Directed Pacing CatheterLDF · Traditional | St Jude Medical | 11/22/2016SE |
| K160260 | Tempo Temporary Pacing LeadLDF · Traditional | Biotrace Medical, Inc. | 10/25/2016SE |
| K161249 | Streamline 6495 Bipolar Temporary Myocardial Pacing LeadLDF · Special | Medtronic | 08/19/2016SE |
| K152784 | Pacel Bipolar Pacing CathetersLDF · Special | St Jude Medical | 10/22/2015SE |
| K152633 | Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing ProbeLDF · Special | Edwards Lifesciences, LLC | 10/15/2015SE |
| K140972 | Unipolar Pediatric Temporary Pacing Lead, Unipolar Temporary Atrial Pacing Lead…LDF · Special | Medtronic, Inc. | 06/06/2014SE |
| K072770 | Temporary Pacing Lead, Series TBB, Model Helios (TM)LDF · Traditional | Oscor, Inc. | 01/22/2008SE |
| K042190 | Model 6416 Temporary Pacing Lead SystemLDF · Special | Medtronic Vascular | 09/07/2004SE |
| K040812 | Detect Surgical Pacing and Mapping ToolLDF · Traditional | Medtronic Vascular | 09/02/2004SE |
| K033858 | Temporary Bipolar Myocardial Pacing WireLDF · Traditional | European Custom Manufacturing BV | 07/12/2004SE |
| K032613 | Temporary Transvenous Pacemaker Placement Assist DeviceLDF · Traditional | Peter M. Rothenberg, M.D. | 11/20/2003SE |
| K023174 | Disposable Temporary Pacing WireLDF · Traditional | River Medical, Inc. | 06/11/2003SE |
| K030556 | Steelex Electrode SetLDF · Traditional | Aesculap, Inc. | 04/22/2003SE |
| K011660 | Weck Cardiac Pacing WiresLDF · Traditional | Weck Closure Systems | 08/21/2001SE |
| K012460 | Model 6495 Bipolar Temporary Myocardial Pacing LeadLDF · Special | Medtronic Vascular | 08/14/2001SE |
| K012459 | Model 6494 Unipolar Temporary Myocardial Pacing WireLDF · Special | Medtronic Vascular | 08/14/2001SE |
| K012458 | Model 6492 Unipolar Temporary Atrial Pacing LeadLDF · Special | Medtronic Vascular | 08/14/2001SE |
| K012454 | Model 6491 Unipolar Pediatric Temporary Pacing LeadLDF · Special | Medtronic Vascular | 08/14/2001SE |
| K012452 | Model 6500 Unipolar Temorary Myocardial Pacing LeadLDF · Special | Medtronic Vascular | 08/14/2001SE |
| K010099 | Zynergy Z3K Balloon Guided Pacing and Monitoring CatheterLDF · Special | Zcv ,Inc. | 02/01/2001SE |
| K002603 | Zynergy Balloonpace Balloon Guided Pacing and Monitoring CatheterLDF · Traditional | Zcv ,Inc. | 01/08/2001SE |
| K002481 | Zynergy Featherpace Transvenous Bipolar Catheter, Model 04-X-02-3-10-3LDF · Traditional | Zcv ,Inc. | 12/07/2000SE |
| K002687 | Zynergy Z4 Transvenous Bipolar Pacing Catheter, Model 04-X-02-3-10-3LDF · Traditional | Zynergy Cardiovascular, Inc. | 11/09/2000SE |
| K973360 | Medtronic Model 6416 Transvenous Bipolar Temporary Pacing LeadLDF · Traditional | Medtronic Vascular | 05/26/1998SE |
| K980503 | Temporary Cardiac Pacing WireLDF · Traditional | ETHICON, Inc. | 04/10/1998SE |
| K971775 | Interim Av Shaped Temporary Pacing Catheter Model INT-AV610LDF · Traditional | Cardiac Control Systems, Inc. | 12/29/1997SE |
| K955829 | Safpace SystemLDF · Traditional | B.Braun Medical, Inc. | 11/18/1997SE |
| K962833 | Harmac Temporary Pacing Catheter with BalloonLDF · Traditional | Harmac Medical Products, Inc. | 10/15/1997SE |
| K963073 | Harmac Bipolar Temporary Pacing Catheter with StyletLDF · Traditional | Harmac Medical Products, Inc. | 08/14/1997SE |
| K971165 | Introducer Sheath and DilatorLDF · Traditional | Boston Scientific Corp | 07/23/1997SE |
| K963898 | Model 6495 Bipolar Temporary Pacing LeadLDF · Traditional | Medtronic Vascular | 07/22/1997SE |
| K961520 | Unipolar Ipg Ground Cable, Model 5473LDF · Traditional | Medtronic Vascular | 11/13/1996SE |
| K960479 | Arrow Bipolar Pacing/Balloon Wedge Pressure CatheterLDF · Traditional | Arrow Intl., Inc. | 10/17/1996SE |
| K955712 | Usci Bipolar Balloon Pacing Electrode with BH CoatingLDF · Traditional | C.R. Bard, Inc. | 10/11/1996SE |
| K962467 | RV Pacing LeadLDF · Traditional | Abbott Laboratories | 09/17/1996SE |
| K955722 | Flexon Temporary Cardiac Pacer LeadLDF · Traditional | Davis & Geck, Inc. | 03/15/1996SE |
| K954809 | Unipolar Temporary Myocardial Pacing Wire Model 6494LDF · Traditional | Medtronic Vascular | 12/13/1995SE |
| K934785 | MultipaceLDF · Traditional | Electro-Catheter Corp. | 07/27/1995SE |
| K944966 | Unipolar Atrial Temporary Pacing Lead,Model 6492LDF · Traditional | Medtronic Blood Systems, Inc. | 07/14/1995SE |
| K944957 | Temporary Myocardial Pacing Lead, Model 6500LDF · Traditional | Medtronic Blood Systems, Inc. | 07/14/1995SE |
| K944956 | Unipolar Pediatric Temporary Pacing Lead, Model 6491LDF · Traditional | The Heart Valve Div. Medtronic Cardiovascular Surg | 07/14/1995SE |
| K934787 | Silicore Semi-FloaterLDF · Traditional | Electro-Catheter Corp. | 02/24/1995SE |
| K930069 | Bipolar Balloon Pacing Catheter by J-LloydLDF · Traditional | J-Lloyd Medical, Inc. | 01/28/1994SE |
| K924388 | Angemed Model 4000 QC Bipolar Temp Pacing LeadLDF · Traditional | Angemed, Inc. | 10/21/1993SE |
| K924390 | Angemed 5000 Lead AdapterLDF · Traditional | Angemed, Inc. | 08/25/1993SE |
| K922269 | Unipolar Temporary Myocardial Pacing Wire, 6493LDF · Traditional | The Heart Valve Div. Medtronic Cardiovascular Surg | 11/23/1992SE |
| K922268 | Unipolar Pediatric Temporary Pacing Lead Mod. 6491LDF · Traditional | Medtronic Vascular | 11/23/1992SE |
| K922182 | Unipolar Atrial Temporary Pacing Lead, Model 6492LDF · Traditional | Medtronic Vascular | 11/23/1992SE |
| K923407 | Medtronic Models 5455L and 5455SL Surgical CablesLDF · Traditional | Medtronic Vascular | 10/19/1992SE |
| K914185 | Pacel(Tm) Flow Directed Pacing CatheterLDF · Traditional | Daig Corp. | 01/27/1992SE |
| K913521 | Xemex Temporary Pacing Catheter a ModifiedLDF · Traditional | Zeon Medical Corp. | 12/27/1991SE |
| K904868 | Xemex Temporary Pacing Catheter aLDF · Traditional | Zeon Medical Corp. | 05/16/1991SE |
| K902342 | Unipolar Pediatric Temporary Pacing Lead, #6491LDF · Traditional | Medtronic Vascular | 10/16/1990SE |
| K900982 | E-ClipLDF · Traditional | Joel Cohen & Esther R. Cohen | 04/19/1990SE |
| K895789 | Unipolar Temp. Myocardial Heart Wire, Model 6490LDF · Traditional | Medtronic Vascular | 12/07/1989SE |
| K890988 | Model 3110 Heart Wire & 3110P Pediatric Heart WireLDF · Traditional | Pace Medical | 08/25/1989SE |
| K890794 | Daig Pacel(Tm) Flow Directed Pacing CatheterLDF · Traditional | Daig Corp. | 06/20/1989SE |
| K884866 | Temp. Pacing Leads W/Depth Markings TA-1 and TB-1LDF · Traditional | Oscor Medical Corp. | 03/22/1989SE |
| K882330 | Bard Baim-Turi Balloon Diagnostic Pacing CatheterLDF · Traditional | C.R. Bard, Inc. | 09/06/1988SE |
| K882045 | High Torque Temporary Pervenous Lead W/Depth MarkLDF · Traditional | Cordis Leads, Inc. | 07/12/1988SE |
| K881356 | External Pacemaker Wire Dressing ChangeLDF · Traditional | Neal & Assoc., Inc. | 05/19/1988SE |
| K875059 | Disposable Bipolar Temporary Pacing ElectrodeLDF · Traditional | Daig Corp. | 02/12/1988SE |
| K874310 | Wire DressingLDF · Traditional | Slocum and Neal, Inc. | 12/23/1987SE |
| K872972 | Temporary Pacemaker ElectrodeLDF · Traditional | Oscor Medical Corp. | 12/03/1987SE |
| K873728 | Deknatel Temporary Cardiac Pacing WireLDF · Traditional | Deknatel, Inc. | 11/03/1987SE |
| K873474 | Sutureless Temporary Epicardial Pacing LeadLDF · Traditional | Symbion, Inc. | 10/07/1987SE |
| K873716 | Adult Walking Heel Product No. 4183-130LDF · Traditional | Martin Medical | 10/02/1987SE |
| K862970 | Temporary Myocardial Pacing Lead, Model 6500LDF · Traditional | Medtronic Vascular | 09/25/1987SE |
| K864507 | V-Pace(Tm) Transluminal Ventricular/ Model SP5540LDF · Traditional | Spectramed, Inc. | 03/06/1987SE |
| K861403 | TB Series Bipolar Pacing LeadsLDF · Traditional | Oscor Medical Corp. | 06/27/1986SE |
| K861409 | Syncare Temporary Cardiac Pacing WireLDF · Traditional | Gyneco, Inc. | 05/05/1986SE |
| K855139 | Flexon Temporary Cardiac Conductive MultifilamentLDF · Traditional | Davis & Geck, Inc. | 02/26/1986SE |
| K853818 | Medtronic Model 6405LDF · Traditional | Medtronic Vascular | 10/11/1985SE |
| K852797 | Heparin Coat Tran Ballo Tip Temp Pac ElectrodeLDF · Traditional | Mansfield Scientific, Inc. | 09/16/1985SE |
| K852513 | 115-GK Bard Care Translu Ventricular Pacing LeadLDF · Traditional | C.R. Bard, Inc. | 09/16/1985SE |
| K851913 | Cordis High-Torque Temp. Pervenous Lead W/Depth MaLDF · Traditional | Cordis Corp. | 09/16/1985SE |
| K851845 | Numed Temp. Stylet Pacing Parobe 1318694LDF · Traditional | NuMED, Inc. | 08/29/1985SE |
| K851246 | Numed Balloon Pacing CatheterLDF · Traditional | NuMED, Inc. | 04/19/1985SE |
| K850622 | Oscor Medical Model Tme 64S Bipolar Temp/Heart WirLDF · Traditional | Oscor Medical Corp. | 04/10/1985SE |
| K850324 | Elecath Open Tip Bipolar Pacing CatheterLDF · Traditional | Electro-Catheter Corp. | 03/27/1985SE |
| K843290 | Numed Balloon Pacing CatheterLDF · Traditional | NuMED, Inc. | 01/14/1985SE |
| K844003 | Elecath Ventricular Pacing Wedge Pressure CathLDF · Traditional | Electro-Catheter Corp. | 12/27/1984SE |
| K841802 | Electrode Catheter, Orthogonal TypeLDF · Traditional | Webster Laboratories, Inc. | 10/18/1984SE |
| K843141 | Critikon Heparin-Coated CardiovascularLDF · Traditional | Critikon Company, LLC | 09/04/1984SE |
| K834416 | Lumelec Electrode CatheterLDF · Traditional | Cordis Corp. | 04/24/1984SE |
| K840109 | Elecath Heparin Coated Temp. PacingLDF · Traditional | Electro-Catheter Corp. | 02/04/1984SE |
| K831804 | Multipolar Temporary CardiacLDF · Traditional | Oscor, Inc. | 10/20/1983SE |
| K831695 | Temp. Cardiac Pacing Wire Tme 60/61/65LDF · Traditional | Oscor, Inc. | 10/20/1983SE |
| K832850 | Elecath Pacewedge Dual Press. BipolarLDF · Traditional | Electro-Catheter Corp. | 10/19/1983SE |
| K832561 | Epcor Multielectrode Temp. PervenousLDF · Traditional | Cordis Corp. | 10/19/1983SE |
| K831645 | Temp. Bipolar Epicardial LeadLDF · Traditional | Cordic Corp. | 07/26/1983SE |
| K830772 | Temp. Pacing Lead, Bipolar #TH60, 90/110LDF · Traditional | Oscor, Inc. | 04/18/1983SE |
| K830094 | Usci Temp. Atrio-Ventricular ElectrodeLDF · Traditional | C.R. Bard, Inc. | 02/18/1983SE |
| K822003 | Balloon Temp. Pacing CatheterLDF · Traditional | Ziehm International, Inc. | 10/15/1982SE |
| K822002 | Bipolar Temp. Pacing Catheter W/StyletetLDF · Traditional | Ziehm International, Inc. | 10/15/1982SE |
| K822155 | Ethicon Temporary Cardiac Pacing WireLDF · Traditional | ETHICON, Inc. | 08/24/1982SE |
| K821518 | Myo/ClipLDF · Traditional | Alto Development Corp. | 07/08/1982SE |
| K821333 | Atrial J Temporary Pacing ElectrodessLDF · Traditional | Medics Instrument Corp. | 06/02/1982SE |
| K820232 | Transthoracic Temp. Pacemaker #100TPELDF · Traditional | Trans Pace, Inc. | 04/09/1982SE |
| K820003 | Cardiovascular Temp. Pacemaker ElecLDF · Traditional | Diag Corp. | 03/26/1982SE |
| K813521 | Transluminal Bipolar Pacing ProbeLDF · Traditional | American Edwards Laboratories | 03/15/1982SE |
| K813138 | Ethicon* Temp. Cardiac Pacing WireLDF · Traditional | ETHICON, Inc. | 12/10/1981SE |
| K812725 | Model 5867-12 Bipolar Low-Profile LeadLDF · Traditional | Medtronic Vascular | 11/16/1981SE |
| K812781 | Temporary Pervenous J-Atrial LeadLDF · Traditional | Cordis Corp. | 10/29/1981SE |
| K812517 | Cardiac Pacing ElectrodesLDF · Traditional | Medics Instrument Corp. | 10/13/1981SE |
| K812307 | Usci Transthoracic Temp. Pacing ElectrodLDF · Traditional | C.R. Bard, Inc. | 09/21/1981SE |
| K811318 | Temporary Endocardial Tripolar Ld. #6880LDF · Traditional | Medtronic Vascular | 07/20/1981SE |
| K803086 | Myowire-Atemporary Cardiac Pacing WireLDF · Traditional | Craig & Craig, Inc. | 07/01/1981SE |
| K810657 | Temptron #'S 6804/6805LDF · Traditional | Medtronic Vascular | 04/08/1981SE |
| K810643 | Universal Pacing Electrode KitLDF · Traditional | Stanco Medical, Inc. | 04/08/1981SE |
| K810642 | Atrial-Ventricular Pacing Electrode KitLDF · Traditional | Stanco Medical, Inc. | 04/08/1981SE |
| K810312 | Elecath Dual Mode Transthoracic PacingLDF · Traditional | Electro-Catheter Corp. | 03/04/1981SE |
| K810041 | Cordis Temporaty Curved Atrial LeadLDF · Traditional | Cordis Corp. | 02/05/1981SE |
| K803058 | Swan-Ganz Flow-Directed Multipur. Cath.LDF · Traditional | American Edwards Laboratories | 01/16/1981SE |
| K801799 | Atrial/Ventricular Seqential #080-20000LDF · Traditional | Medical Testing System, Inc. | 01/02/1981SE |
| K802259 | Transvenous Pacemaker Electrode KitLDF · Traditional | Stanco Medical, Inc. | 10/23/1980SE |
| K801800 | Universal Temp. Pacing Elect. #080-10000LDF · Traditional | Medical Testing System, Inc. | 10/23/1980SE |
| K800298 | Usci Bipolar Ballon Pacing ElectrodeLDF · Traditional | C.R. Bard, Inc. | 04/16/1980SE |
| K791183 | Swan-Ganz Flow-Directed CatheterLDF · Traditional | Edwards Lifesciences, LLC | 07/12/1979SE |
| K781002 | Temporary Cardiac Pacing WireLDF · Traditional | ETHICON, Inc. | 12/04/1978SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2383-2026 Class I | Description/REF: PACING/PSI KIT: 5 FR 2L/ASK-07155-MGULidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits… | Arrow International, LLC | 04/21/2026Open, Classified |
| Z-2993-2024 Class II | Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2992-2024 Class II | Medline convenience kits labeled as: 1) ANGIOGRAPHY DRAPE PACK, Pack Number 00-398281J…Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2991-2024 Class II | Medline Convenience kits labeled as: CARDIAC PACING PACK, Pack Number DYNJ41223Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024.… | MEDLINE INDUSTRIES, LP - Northfield | 04/08/2024Open, Classified |
| Z-2098-2019 Class II | A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode…Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be… | Alto Development Corp | 06/21/2019Terminated |
| Z-0391-2019 Class I | TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial…During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the… | Oscor, Inc. | 09/26/2018Terminated |
| Z-2200-2016 Class II | Medtronic, Temporary Pacing Lead System, Model 6416, Sterile EO. Product Catalog…This Pacing Lead System does not comply with Section 8.5.2.3 of IEC 60601-1, and corresponding provisions of… | Medtronic Inc., Cardiac Rhythm and Heart… | 06/16/2016Terminated |
| Z-1435-2013 Class II | Vermed, Inc Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible…On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used… | Heart Sync, Inc | 04/26/2013Terminated |
| Z-1434-2013 Class II | Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic…On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used… | Heart Sync, Inc | 04/26/2013Terminated |
| Z-0165-2013 Class II | Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing…Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C, TME64S-3… | Oscor, Inc. | 07/25/2012Terminated |
| Z-1038-2012 | Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use…The crimping operation during product production was not performed properly. As such, the pacing wire may… | European Custom Manufacturing B.V. | 04/18/2011Terminated |
| Z-1500-2009 | Arrow Balloon and stylet temporary pacing catheterLeakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing… | Arrow International Inc | 02/11/2009Terminated |
| Z-1173-2009 | Medtronic STREAMLINE Bipolar Temporary Myocardial Pacing Lead, 6495, Sterile EO, REF…Medtronic is recalling one lot of STREAMLINE Bipolar Myocardial Temporary Pacing Leads, Model 6495, Lot… | Medtronic Inc | 02/06/2009Terminated |
| Z-1908-2008 | Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-IK, Lot number…The 5 Fr. (110cm) Temporary Pacing Catheter/ 6 Fr. Introducer Kits do not contain a complete 6 Fr.… | Arrow International Inc | 04/01/2008Terminated |
| Z-1907-2008 | Arrow Balloon Temporary Pacing Catheter Kits, Part number AI-07155-KS, Lot number…The 5 Fr. (110cm) Temporary Pacing Catheter/ 6 Fr. Introducer Kits do not contain a complete 6 Fr.… | Arrow International Inc | 04/01/2008Terminated |