Agency classClass IIOur severity:Severe FDA (Devices)·Z-1185-2013·Announced 2013-05-08

Medi-Trace Pediatric Defibrillation Electrodes Recalled for Arcing Risk

FDA is recalling Medi-Trace Cadence Pediatric Defibrillation Electrodes because arcing or sparking may damage the leadwire, 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (thermal damage to leadwire) that could prevent the delivery of life-saving energy, meeting the criteria for a Severe rating.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling the Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode (Product ID: 22550P). The recall involves 7,485 sets of 2 units. The product is intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.

The recall was initiated because the defibrillation electrodes may arc or spark, which can result 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 228651, 232146, 235646X, 301833X, and 303928X.

The product was distributed worldwide, including nationwide in the United States and in Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa. The FDA has classified this as a Class II recall. Users should stop using the affected devices and contact the manufacturer, Covidien LLC, for further instructions.

The recalled product

Product: Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
Manufacturer: Covidien LLC
Category: Medical Device — Defibrillation Electrodes
Hazard: arcing
thermal-damage
device-failure

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 (5)

Lot Numbers: 228651
232146
235646X
301833X
303928X

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.

See all 2 products in this recall →

Same manufacturer · Covidien LLC

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Same hazard · arcing