CLASS I Device recall · Reported 22 Oct 2014 · FDA Enforcement Report

Coviden Medi-Trace Cadence Adult Multi-Function recalled by Covidien

Covidien is recalling Coviden Medi-Trace Cadence Adult Multi-Function Defibrillation Electrodes, Pre-connected, distributed nationwide in the US. The recall was initiated on 18 Sep 2014 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAl lot codes

Quantity recalled9,850 pairs

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0044-2015
FDA event ID: 69257
Recalling firm: Covidien, Mansfield, MA
Classification: Class I
Status: Terminated
Recall initiated: 18 Sep 2014
FDA classified: 16 Oct 2014
Reported: 22 Oct 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Test Kits & Diagnostics

Timeline

18 Sep 2014	Recall initiated by company
16 Oct 2014	Classified by FDA	+28 days
22 Oct 2014	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

Worldwide Distribtion-USA (nationwide) including Puerto Rico and the countries of Canada Greece Israel Belgium Finland France Germany Great Britain Ireland Italy Norway Poland Portugal Spain Sweden Switzerland Brazil Chile Philippines Taiwan Australia New Zealand.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Al lot codes

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 69257

Reported	Class	Recall	Company	Reason	Where
22 Oct 2014	CLASS I	Medi-Trace Cadence and Kendall Adult Multi-Function recalled by Covidien	Covidien	Other	Nationwide
22 Oct 2014	CLASS I	Kendall 1710H Multi-Function Defibrillation Electrodes recalled	Covidien	Other	Nationwide
22 Oct 2014	CLASS I	MediChoice¿ Multifunction Electrode recalled by Covidien	Covidien	Other	Nationwide
22 Oct 2014	CLASS I	Philips Heartstart Multifunction Electrode Pads recalled by Covidien	Covidien	Other	Nationwide
22 Oct 2014	CLASS I	Kendall Adult Multi-Function Defibrillation Electrodes recalled	Covidien	Other	Nationwide

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