The Recall Desk
HighFDA (Devices)·Z-0940-2022·Announced 2022-04-20

CLARAVUE ECG Electrode May Fail to Deliver Effective Defibrillation

CLARAVUE Pre-wired ECG electrodes may not meet electrical safety standards for defibrillation, potentially delivering an ineffective electrical charge during emergency use. This is a Class II recall affecting devices nationwide.

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 a Class II medical device recall with no reported injuries or illnesses. The hazard is failure to meet electrical defibrillation standards that may result in ineffective defibrillation—a theoretical risk-of-harm scenario. Per the rubric, such recalls without reported injuries score at most 3 (High).

Plain-English summary

This is a Class II recall of CLARAVUE Pre-wired Electrode IP SET 5V RT ADULT (Model 32028781 50604-US), manufactured by Graphic Controls Acquisition Corporation. The device is an ECG electrode used in emergency defibrillation settings.

The product instructions state that the device complies with ANSI/AAMI EC53:2013/(R)2020 standards for ECG trunk cables and patient leadwires. This standard requires devices to withstand 5,000 volts DC without breakdown when used with a defibrillator at voltage above its maximum threshold. However, testing has shown that Claravue does not meet this electrical specification.

As a result, the device may deliver an inefficient electrical charge during defibrillation, potentially resulting in ineffective defibrillation. The product is distributed nationwide in Arkansas, California, Colorado, Florida, Indiana, Kansas, Massachusetts, Minnesota, New York, Oklahoma, and Vermont. All lots with UDI 03700506307302 are affected by this recall (FDA recall number Z-0940-2022).

The recalled product

Product
CLARAVUE Pre-wired Electrode - IP SET 5V RT ADULT Model: 32028781 50604-US
Manufacturer
Graphic Controls Acquisition Corporation
Category
Medical Device — ECG/Defibrillator Electrode
Hazard
  • ineffective-defibrillation
  • electrical-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: 03700506307302

Distribution

Distributed nationwide across the United States.

Related recalls

Same category