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
- Hazard
- electrical-safety-defect
- defibrillation-failure
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.
Related recalls
Same category
- HighZimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution Tissue Stabilizer Model TS2000 tubing assembly error
FDA (Devices) · 2026-07-01
- HighSurgify Halo Surgical Burr Recalled for Breakage Risk
FDA (Devices) · 2026-07-01
- SevereMedline Polycarbonate Syringes in Convenience Kits Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01
- HighSurgify Halo Surgical Burr Recalling Potential Tool Breakage Risk
FDA (Devices) · 2026-07-01