Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)

Reports per year

Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2015-09-02TerminatedProcess control

  MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PC

  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

• 2015-09-02TerminatedProcess control

  MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC

  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

• 2014-10-15TerminatedDevice Design

  Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R

  Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators

• 2014-10-15TerminatedDevice Design

  Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected Part Number: 22660PC

  Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs

• 2014-10-15TerminatedDevice Design

  Covidien Kendall Adult Multi-Function Defibrillation Electrodes Part Number: 20660

  Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs

• 2014-10-15TerminatedDevice Design

  Philips HEARTSTART Multifunction Electrode Pads Part Number: M3718A

  Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs

• 2013-05-30TerminatedProcess control

  adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring.

  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

• 2013-04-29TerminatedProcess control

  Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.

  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

• 2013-04-29TerminatedProcess control

  Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.

  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

• 2011-01-24TerminatedOther

  Welch Allyn PIC 50 Portable Intensive Care System. Model 971081 series. Designed for use in and out of the hospital.

  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.