Agency classClass IIOur severity:Severe FDA (Devices)·Z-2546-2015·Announced 2015-09-09

MediTrace Cadence Defibrillation Electrodes Recalled for Wire Insulation Damage

Covidien LLC is recalling MediTrace Cadence Adult Zoll defibrillation electrodes due to potential wire insulation damage that could 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 recall is classified as FDA Class II and involves a risk of patient and/or clinician burns, which aligns with the rubric criterion for 'Severe' (FDA Class II with significant injury reports or potential for significant harm).

Plain-English summary

Covidien LLC is recalling 114,000 sets of MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrodes, Nonsterile (Item Code: 22770PC). The recall involves specific lot numbers: 516313X, 519124X, and 513426X. These products were distributed nationwide and in Canada, Australia, Denmark, Germany, and New Zealand.

The recall is issued because potential damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patient and/or clinician burns. This is an FDA Class II recall, indicating a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.

Healthcare facilities and distributors should stop using the affected lots and contact the recalling firm for instructions on return or replacement. Consumers who have purchased these products should contact their healthcare provider or the manufacturer for guidance.

The recalled product

Product: MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC
Manufacturer: Covidien LLC
Category: Medical Device — Defibrillation Electrodes
Hazard: burn-injury
reduced-therapy
Affected units: 114,000

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 (3)

Lot Numbers: 516313X
519124X
513426X

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