Food, drugs, devices › Covidien LLC
Device recall: MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PC
FDA enforcement event 71963 is a device recall by Covidien LLC of North Haven, CT, initiated 19 Aug 2015 and classified Class II, with 3 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 24 May 2017. Initiation: voluntary: firm initiated. Covidien LLC has 77 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Covidien LLC, North Haven, CT.
Reason for recall
"Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patient and/or clinician burns"
Distribution
"Nationwide Foreign: Canada Australia Denmark Germany New Zealand"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2545-2015 | MediTrace Cadence Adult Multi-Function Defibrillation Electrodes Item Code:22550PC | 7660 sets | Class II | Terminated | 9 Sep 2015 |
| Z-2546-2015 | MediTrace Cadence Adult Zoll, Preconnect Defibrillation Electrode, Nonsterile Item Code:22770PC | 114,000 sets | Class II | Terminated | 9 Sep 2015 |
| Z-2547-2015 | Physio-Control QuikCombo Pacing/Defibrillation/ECG Electrodes RediPak¿ Preconnect System Item Code:PM20022 | 56,000 sets | Class II | Terminated | 9 Sep 2015 |
Context
Other enforcement events for Covidien LLC
All 77 events for Covidien LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Multi-Function Defibrillation Electrodes, Pre connect- potential for damage to the wire insulation may result in a potentially increased risk for reduced or no patient therapy and patient and/or clinician burns"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Foreign: Canada Australia Denmark Germany New Zealand"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 24 May 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.