Verathon Recalls GlideScope Core OneTouch Smart Cables Due to Connection Defect
Verathon is recalling 437 GlideScope Core OneTouch Smart Cables because twisting during connection may damage the internal circuit board, causing video loss during critical intubation procedures.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "When video laryngoscopy system users apply, twisting motions while connecting the blade in the HDMI port, or excessive torsion to the connection port, this force is transferred to the HDMI PCB, which may result in video synchronization…"
Plain-English summary
Verathon, Inc. is recalling 437 units of the GlideScope Core OneTouch Smart Cable (REF: 0800 0601). This accessory is used with the GlideScope Video Laryngoscope System and is distributed in the United States, Australia, and the United Kingdom. The recall covers all serial numbers.
The recall is due to a defect where applying twisting motions or excessive torsion while connecting the blade to the HDMI port transfers force to the internal circuit board. This damage may result in video synchronization interruptions, a blank screen, or a 'no cameras connected' warning. Such failures may present a risk to patients during intubation procedures where visual guidance is critical.
Healthcare facilities and users of the GlideScope Video Laryngoscope System should stop using the affected cables and contact Verathon, Inc. for instructions on replacement or repair.
The recalled product
- Product
- GlideScope Core OneTouch Smart Cable, REF: 0800 0601, an accessory to the GlideScope Video Laryngoscope System Per PLRA: The Core OneTouch Cables (Reusable Device) is ancillary equipment used with the Core 10 and Core 15 monitors. The monitor and workstation are intended to…
- Manufacturer
- Verathon, Inc.
- Affected units
- 437
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 serial numbers
Distribution
Distributed nationwide across the United States.
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