Medi-Trace Cadence Pediatric Radiotransparent Defibrillation… — Class II medical device recall Z-1185-2013
Terminated recall by Covidien LLC, reported 2013-05-08, distributed nationwide. Defibrillation Electrodes may arc/spark result in thermal damage to the leadwire, which could render the devic
| Recall number | Z-1185-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, Mansfield, MA, United States |
| Recall initiated | 2013-04-08 |
| Classified | 2013-04-29 |
| Reported by FDA | 2013-05-08 |
| Terminated | 2015-11-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BR, CA, JP, KR, SG, ZA |
| Lot numbers | 228651, 232146, 235646X, 301833X, 303928X |
Product
Medi-Trace Cadence Pediatric Radiotransparent Defibrillation Electrode Product ID: 22550P. Intended for use in cardioversion, pacing, ECG monitoring, and defibrillation procedures.
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1185-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.