Z-1185-2013Class II

Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use...

Name: Z-1185-2013 Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use...
Creator: Covidien LLC
Published: 2013-04-08
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2013-04-08 / Terminated / root cause: manufacturing process

FDA source

Covidien LLC began a recall of Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and... on 2013-04-08. FDA classified it as Class II and gives the reason as "Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1185-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-08
Posted: 2013-04-29
Terminated: 2015-11-19
Recalling firm: Medtronic, Inc.
Product: Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
Product code: DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Reason for recall: Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the device incapable of delivering the appropriate energy or shock to the patient
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Covidien sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 8, 2013 to all affected customers. The letter identifies the product, problem and requests that customers immediately stop using and segregate any affected product from inventory. Questions:Call 1-800-962-9888 option 8, then extension 2500.
Quantity in commerce: 7485 (sets of 2)
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa.
Product codes and lots: Lot Numbers: 228651, 232146, 235646X, 301833X, 303928X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1185-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1184-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-08	2013-04-29
Z-1185-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-08	2013-04-29

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)