Medi-Trace Cadence Adult Defibrillation Electrodes Recalled for Thermal Damage Risk
FDA is recalling Medi-Trace Cadence Adult Defibrillation Electrodes because arcing or sparking may cause thermal damage to the leadwire, potentially preventing the device from delivering appropriate energy to patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (failure to deliver appropriate energy) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrodes (Product ID: 22550R) manufactured by Covidien LLC. The recall involves 133,470 sets of 2 electrodes. These products are intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
The recall was initiated because the defibrillation electrodes may arc or spark, resulting in thermal damage to the leadwire. This damage could render the device incapable of delivering the appropriate energy or shock to the patient. The affected lot numbers are 226543X, 230054X, 230814X, 232182X, 232805X, 234245X, 304667X, 301844X, 300446X, and 305320X.
The products were distributed worldwide, including nationwide in the United States and in Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa. Healthcare facilities and users should stop using the affected products and contact the manufacturer for further instructions.
The recalled product
- Product
- Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
- Manufacturer
- Covidien LLC
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Lot Numbers: 226543X
- 230054X
- 230814X
- 232182X
- 232805X
- 234245X
- 304667X
- 301844X
- 300446X
- 305320X
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Covidien LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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