The Recall Desk
HighFDA (Devices)·Z-0935-2022·Announced 2022-04-20

ECG Electrode Set Fails Electrical Safety, May Prevent Effective Defibrillation

Graphic Controls' CLARAVUE pediatric electrode set fails electrical safety standards. The device may not deliver adequate charge during defibrillation, potentially rendering emergency treatment ineffective.

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: FDA Class II medical device with failure to meet mandatory electrical safety standards (ANSI/AAMI EC53). Although no reported illnesses or injuries exist, the risk of ineffective defibrillation in a critical medical scenario constitutes a high-severity hazard.

Plain-English summary

Graphic Controls Acquisition Corporation is recalling the CLARAVUE Pre-wired Electrode IP-SET N3 (Model 32028776 50401-US) for pediatric use. The device consists of pre-wired ECG trunk cables and patient leadwires marketed for pediatric cardiac monitoring.

The product does not comply with the ANSI/AAMI EC53:2013/(R)2020 standard for ECG cables and leadwires. Specifically, the device fails to withstand 5,000 volts direct current when used with a defibrillator operating at or above its maximum voltage threshold. This failure results in the device delivering an inefficient electrical charge.

As a result, the electrode set may not deliver adequate electrical charge during defibrillation therapy, potentially rendering treatment ineffective when patients require emergency defibrillation.

Healthcare facilities and clinicians using this product should discontinue use immediately. Contact Graphic Controls Acquisition Corporation or the FDA if you have questions or have observed any issues related to this product.

The recalled product

Product
CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US
Manufacturer
Graphic Controls Acquisition Corporation
Category
Medical Device — Cardiac Monitoring
Hazard
Affected units
40

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: 03700506307357

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 →

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