The Recall Desk
HighFDA (Devices)·Z-0939-2022·Announced 2022-04-20

Cardiac electrode fails electrical safety test; defibrillation may not work

The CLARAVUE Pre-wired Electrode does not meet electrical safety standards for defibrillators. It may not deliver effective electrical charge during emergency defibrillation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a medical device with a critical safety function—defibrillation—that fails electrical safety standards. No injuries or illnesses have been reported. The hazard is theoretical (potential ineffective defibrillation) rather than confirmed, meeting the criterion of risk-of-harm products where injury has not yet been reported.

Plain-English summary

Graphic Controls Acquisition Corporation is recalling the CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US (Model 32028780 50603-US). The device is used with defibrillators to deliver electrical therapy during cardiac emergencies.

The device does not meet the electrical safety standard ANSI/AAMI EC53:2013/(R)2020, which requires it to withstand 5,000 volts DC without failure. According to the manufacturer's Instructions for Use, the CLARAVUE electrode fails this test and delivers an inefficient electrical charge, which may result in ineffective defibrillation.

The device was distributed nationwide in Arkansas, California, Colorado, Florida, Indiana, Kansas, Massachusetts, Minnesota, New York, Oklahoma, and Vermont. All lots are affected (UDI 03700506307319). Healthcare facilities and individuals with this device should contact Graphic Controls Acquisition Corporation for instructions.

The recalled product

Product
CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US
Manufacturer
Graphic Controls Acquisition Corporation
Category
Medical Device — Defibrillation Electrode
Hazard

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)

  • All lots UDI: 03700506307319

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Part of a larger recall action

This product is one of 6 recalled by Graphic Controls Acquisition Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Graphic Controls Acquisition Corporation

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