FDA Medical Device Recalls (openFDA)
Covidien LLC: Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
- Recall number
- Z-1185-2013
- Recalling firm
- Covidien LLC
- Product
- Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
- Status
- Terminated
- Initiated
- 2013-04-08
- Posted
- 2013-04-29
- Terminated
- 2015-11-19
- Reason
- 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
- 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
- 7485 (sets of 2)
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Korea, Japan, Canada, Australia, Brazil, Belgium, Singapore, and South Africa.
- Lot, serial or model codes
- Lot Numbers: 228651, 232146, 235646X, 301833X, 303928X
- 510(k) numbers
- ["K012218"]
- PMA numbers
- not on file
- Product code
- DRO
- Firm FEI
- 1282497
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28