—#117214

Product

Medi-Trace Cadence Adult Radiotransparent Defibrillation Electrode Product ID: 22550R. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.

FDA product code: DRO — Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K012218
Affected lot / code info: Lot Numbers: 226543X, 230054X , 230814X, 232182X, 232805X, 234245X, 304667X, 301844X, 300446X, 305320X

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Covidien LLC
Address: 15 Hampshire Street, Mansfield, Massachusetts 02048-1113

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa.

Timeline

Recall initiated: 2013-04-08
Posted by FDA: 2013-04-29
Terminated: 2015-11-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #117214. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.