Pacemaker, Cardiac, External Transcutaneous (non-invasive)
Cardiovascular · 21 CFR 870.5550
Recent MDR events
599 adverse event reports on file
- CARDINAL HEALTH TM MEDI-TRACE CADENCE ADULT MULTI-FUNCTION DEFIBRILLATION ELECTRJun 3, 2026InjuryCardinal HealthMW5188875
- DEFIBRILLATION ELECTRODESApr 13, 2026InjuryTz Medical, Inc.24858469
- MEDI-TRACE CADENCEDec 26, 2025MalfunctionCardinal Health, Inc.1423537-2025-00520
- MEDI-TRACE CADENCE ADULT DEFIBRILLATION RADIOTRANSPARENT ELECTRODESAug 28, 2025InjuryCardinal HealthMW5175311
- MEDI-TRACE CADENCENov 5, 2024MalfunctionCardinal Health 200, Llc20609346
- MEGA 7.5FR. 40CC IABMay 15, 2024MalfunctionDatascope Corp.2248146-2024-00307
- MEDI-TRACE CADENCE ADULT MULTI-FUNCTIONAL DEFIBRILLATION ELECTRODESJan 9, 2024InjuryCardinalhealth 200, LlcMW5150074
- HEART STIMULATORJan 4, 2024InjuryUnkMW5149863
- HOLTER MONITOR CLARUS 30Oct 18, 2023MalfunctionTz Medical Inc3027815-2023-00001
- CADENCE ZOLL PRECONNECTSep 19, 2023InjuryCardinal Health1219103-2023-00371
Event type breakdown
Recalls
22 recall events for this product code
- Covidien LLCTerminatedSep 2, 2015
MediTrace Cadence Adult Multi-Function Defibrillation Electrodes
Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patient and/or clinician burns
Z-2545-2015 · View FDA record ↗ - Covidien LLCTerminatedSep 2, 2015
MediTrace Cadence Adult Zoll, Preconnect
Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patient and/or clinician burns
Z-2546-2015 · View FDA record ↗ - Covidien LLCTerminatedOct 15, 2014
Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators
Z-0043-2015 · View FDA record ↗ - Covidien LLCTerminatedOct 15, 2014
Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
Z-0044-2015 · View FDA record ↗ - Covidien LLCTerminatedOct 15, 2014
Covidien Kendall Adult Multi-Function Defibrillation Electrodes
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
Z-0045-2015 · View FDA record ↗ - Covidien LLCTerminatedOct 15, 2014
Philips HEARTSTART Multifunction Electrode Pads
Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs
Z-0048-2015 · View FDA record ↗ - TZ Medical Inc.TerminatedMay 30, 2013
adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1.
TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible transparent defibrillation electrodes because it may contain a defective white wire on the connector assembly. If a failure were to occur, the end user would be able to identify the failure by inspecting the white wire 1/4 inch from the Gray Medtronic / Physio adapter. The consignees will notice discolor
Z-1438-2013 · View FDA record ↗ - Covidien LLCTerminatedApr 29, 2013
Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode
Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient
Z-1184-2013 · View FDA record ↗ - Covidien LLCTerminatedApr 29, 2013
Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode
Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient
Z-1185-2013 · View FDA record ↗ - Welch Allyn Protocol, IncTerminatedJan 24, 2011
Welch Allyn PIC 50 Portable Intensive Care System. Model 971081 series.
Potential likelihood that the Portable Intensive Care (PIC) 50 Defibrillator's screen display may fail. The loss of the ability to view the patient's Electrocardiogram (ECG) on the screen could cause the user to delay or fail to administer defibrillating shocks needed to resuscitate a patient.
Z-0937-2011 · View FDA record ↗
Registered firms
29 firms currently registered for this product code
Katmai Integrated Solutions
Brilliant, OH, US
Zoll Medical Corporation
CHELMSFORD, MA, US
Dhl Supply Chain (netherlands) B.v.
Beringe Limburg, NL
Amphenol Alden Products Company
Hermosillo Sonora, MX
Philips Electronics Ltd
Mississauga Ontario, CA
Infusystem Inc.
Lenexa, KS, US
Katecho Llc
DES MOINES, IA, US
Cardinal Health
Hazelwood, MO, US
Cadex Electronics, Inc.
RICHMOND British Columbia, CA
Rrc Power Solutions Ltd.
Fo Tan, N.T., HK
Emi (dongguan) Asia Limited
Dongguan City Guangdong, CN
Makar Consulting Pty Ltd
Belrose New South Wales, AU
Volex Inc
San Diego, CA, US
Katmai Health Services Llc
Brilliant, OH, US
Tribalco
Tampa, FL, US
Worldwide Supplies Limited
Hong Kong, HK
Cd Leycom
Hengelo Overijssel, NL
Quipment
Nancy Meurthe-et-Moselle, FR
Cardinal Health
CHICOPEE, MA, US
Cardinal Health 200, Llc
Waukegan, IL, US
Remote Diagnostic Technologies Ltd.
FARNBOROUGH Hampshire, GB
510(k) clearances
84 clearances for this product code
- The Ludlow Company LPOct 12, 2001
K012218 · LUDLOW GRADIENT EDGE ADULT & PEDIATRIC MULTIFUNCTIONAL ELECTRODES
- Katecho, Inc.Oct 12, 2001
K012404 · K-DEFIB/PACE ADULT ELECTRODE, MODEL KDP-85
- Medical Data ElectronicsMar 28, 2000
K000660 · ESCORT II+ 400 SERIES (ESCORT PRISM), MODEL 20400, 20401, 20403, MONITOR, MODELS 20411, 20412, 20413
- Tz Medical, Inc.Sep 15, 1999
K983196 · PADTAK PACE/DEFIB/CARDIOVERT MONITORING ELECTRODE(S)
- Tz Medical, Inc.Sep 15, 1999
K983232 · PADTAK PEDIATRIC DEFIB/CARDIOVERT/PACE/MONITOR-RADIOTRANSPARENT (2X2.25),MODEL 2602, PADTAK PEDIATRIC DEFIB/CARDIOVERT
- Medical Research Laboratories, Inc.Mar 2, 1998
K974034 · PORTABLE INTENSIVE CARE UNIT
- Marquette Electronics, Inc.Mar 6, 1997
K962547 · CARDIOSERV P
- Marquette Electronics, Inc.Feb 28, 1997
K963120 · RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEM