CLASS II Device recall · Reported 2 Mar 2016 · FDA Enforcement Report
9131-001 Defibrillation Electrodes recalled by Cardiac Science
Cardiac Science is recalling 9131-001 Defibrillation Electrodes, distributed nationwide in the US. The recall was initiated on 14 Jan 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0829-2016
- FDA event ID
- 72824
- Recalling firm
- Cardiac Science, Waukesha, WI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Jan 2016
- FDA classified
- 22 Feb 2016
- Reported
- 2 Mar 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Pacemakers & Defibrillators
Timeline
| 14 Jan 2016 | Recall initiated by company | |
| 22 Feb 2016 | Classified by FDA | +39 days |
| 2 Mar 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defibrillation electrodes may increase electrical impedance over time. If impedance becomes too high, the AED will fail the electrode self-test and it will not be Rescue Ready, the AED STATUS INDICATOR will be RED and the AED will beep. This is normal behavior when the impedance limit is exceeded. The high impedance electrodes require replacement.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging. The AED electrodes are used for emergency treatment of cardiac arrest patients over 8 years of age or greater than 55 pounds. The user assesses the patient s condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin.
Where it was distributed
Worldwide Distribution - US all states including PR except ND & RI. International Distribution to Argentina, Australia, Belgium, Bermuda, Canada, Chile, Colombia, Ecuador, France, Germany, Hong Kong, Iceland, Ireland , Israel, Lebanon, Malaysia, Malta, Norway, Oman, Philippines, Poland, Qatar, Romania, Russian Federation, Singapore, Slovenia, Sweden, Turkey, United Kingdom.
Questions about this recall
Is 9131-001 Defibrillation Electrodes recalled?
Yes. Cardiac Science recalled 9131-001 Defibrillation Electrodes on 14 Jan 2016. The recall is Class II and its status is Terminated. Recall number Z-0829-2016.
Why was it recalled?
Defibrillation electrodes may increase electrical impedance over time. If impedance becomes too high, the AED will fail the electrode self-test and it will not be Rescue Ready, the AED STATUS INDICATOR will be RED and the AED will beep. This is normal behavior when the impedance limit is exceeded. The high impedance electrodes require replacement.
Which lots are affected?
Lot No. 141125-02
Where was it sold?
Worldwide Distribution - US all states including PR except ND & RI. International Distribution to Argentina, Australia, Belgium, Bermuda, Canada, Chile, Colombia, Ecuador, France, Germany, Hong Kong, Iceland, Ireland , Israel, Lebanon, Malaysia, Malta, Norway, Oman, Philippines, Poland, Qatar, Romania, Russian Federation, Singapore, Slovenia, Sweden, Turkey, United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Cardiac Science
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|---|---|---|---|---|---|
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