Agency classClass IIOur severity:Severe FDA (Devices)·Z-2545-2015·Announced 2015-09-09

MediTrace Cadence Defibrillation Electrodes Recalled for Wire Insulation Damage

Covidien LLC is recalling MediTrace Cadence Adult Multi-Function Defibrillation Electrodes due to potential wire insulation damage that may cause burns or reduced therapy.

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 source text explicitly states that the defect may result in 'patient and/or clinician burns.' Per the severity rubric, a Class II recall with reports of significant injury (burns) is classified as Severe (Score 4).

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for MediTrace Cadence Adult Multi-Function Defibrillation Electrodes (Item Code: 22550PC) manufactured by Covidien LLC. The recall affects 7,660 sets with Lot Numbers 517521X and 519835X. These products were distributed nationwide and in Canada, Australia, Denmark, Germany, and New Zealand.

The recall is being conducted because there is a potential for damage to the wire insulation. This defect may result in a potentially increased risk for reduced or no patient therapy, as well as patient and/or clinician burns. The FDA classifies this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare facilities and consumers who have these specific lot numbers should stop using the electrodes and contact the recalling firm, Covidien LLC, for instructions on return or replacement. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product: MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PC
Manufacturer: Covidien LLC
Category: Medical Device — Defibrillation Electrodes
Hazard: burn-injury
reduced-therapy
Affected units: 7,660

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 (2)

Lot Numbers: 517521X
519835X

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · Covidien LLC

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Same hazard · burn injury