Cardiac Science Defibrillation Electrodes Recalled for Impedance Issues
Cardiac Science is recalling specific defibrillation electrodes that may develop high electrical impedance, causing AED self-test failures.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional failure mode (self-test failure) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Cardiac Science Corporation is recalling 10,943 units of 9131-001 Defibrillation Electrodes, Lot No. 141125-02. These single-use electrodes are intended for use with Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E automatic external defibrillators (AEDs) to monitor and deliver defibrillation energy to patients.
The recall is due to a defect where the electrodes may increase electrical impedance over time. If the impedance becomes too high, the AED will fail the electrode self-test, the status indicator will turn red, and the device will beep. This behavior indicates the electrodes require replacement to ensure the AED remains Rescue Ready.
The affected products were distributed worldwide, including all US states except North Dakota and Rhode Island, as well as Puerto Rico and numerous international locations. Users should check their AEDs for the specific lot number and replace the electrodes if the self-test fails due to high impedance.
The recalled product
- Product
- 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…
- Manufacturer
- Cardiac Science Corporation
- Affected units
- 10,943
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot No. 141125-02
Distribution
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