Z-0043-2015Class I

Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part...

Name: Z-0043-2015 Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part...
Creator: Covidien LLC
Published: 2014-09-18
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2014-09-18 / Terminated / root cause: design

FDA source

Covidien LLC began a recall of Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R on 2014-09-18. FDA classified it as Class I and gives the reason as "Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0043-2015
Classification: Class I
Status: Terminated
Initiated: 2014-09-18
Posted: 2014-10-15
Terminated: 2017-05-24
Recalling firm: Medtronic, Inc.
Product: Covidien Medi-Trace Cadence and Kendall Adult Multi-Function Defibrillation Electrodes, Radiotransparent Part Number: 22660R
Product code: DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Reason for recall: Covidien Medi-Trace Cadence and Kendall Defibrillation Electrodes Not Compatible for use with Philips model FR3 or FRx AEDs Defibrillators
Root cause tag: design
FDA root cause: Device Design
Action: Covidien notified customers by letter via Federal Express on 9/18/14. The letter requests that they immediately verify that they are not stocking Covidien electrodes for use with Philips FR3 or FRx AED units. A customer reply acknowledgement form is provided to allow Covidien to track the effectiveness of the notification. Covidien is adding a label to all levels of packaging that alerts the user that the product is not compatible with the FR3 and FRx AED units. Distribution partners notified to address product in the distribution chain that is available to be relabeled. For questions customers should call (800) 962-9888, option 8, then extension 2500. For questions regarding this recall call 508-261-8000.
Quantity in commerce: 317,550 pairs
Distribution: 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.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0043-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0043-2015	Class I	Terminated	Voluntary: Firm initiated	2014-10-22	2014-10-16
Z-0044-2015	Class I	Terminated	Voluntary: Firm initiated	2014-10-22	2014-10-16
Z-0045-2015	Class I	Terminated	Voluntary: Firm initiated	2014-10-22	2014-10-16
Z-0046-2015	Class I	Terminated	Voluntary: Firm initiated	2014-10-22	2014-10-16
Z-0047-2015	Class I	Terminated	Voluntary: Firm initiated	2014-10-22	2014-10-16
Z-0048-2015	Class I	Terminated	Voluntary: Firm initiated	2014-10-22	2014-10-16

Product code DRO

K012218Class IILudlow Gradient Edge Adult & Pediatric Multifunctional ElectrodesThe Ludlow Company LP / cleared 2001-10-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)