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| GlideScopt Titanium Single-Use Video Larungoscope--Courtesy of Verathon |
Seattle's Verathon is recalling its GlideScope Titanium Single-Use Video Laryngoscope because the video feed may flicker, potentially leading to "delayed tracheal tube insertion, intubation failure and other serious adverse health consequences, including low levels of oxygen in the blood (hypoxemia), end organ damage or death," the FDA said in a safety alert.
Not surprisingly then, the agency deemed the global recall of 7,733 units of the device a Class I corrective action, reserved for situations 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."
The GlideScope is used to obtain a clear view of the vocal chords to guide the insertion of tracheal tubes used during procedures requiring general anesthesia. The color images are displayed on a monitor that's attached to the device for real-time viewing of the tube insertion process.
Verathon sent customers a recall letter in January. It asked them to destroy or return the affected devices, and said it will replace all GlideScope Titanium Single Use blades that remain in facilities' inventory with a new product that has "passed the enhanced screening test for video flickering."
Medical services provider Stericyle is helping run the recall in the U.S., Australia and Canada.
The company has received about 75 reports of erratic displays related to its rigid laryngoscopes, according to the FDA's total product life cycle report.
Certain models of GlideScope video laryngoscopes were hit with two less severe Class II recalls in December over concerns that its blades may separate "due to inadequate bonding of the silicone adhesive affixing the halves of the blade," the FDA recall database shows.
The recall comes amid a series of efforts to ensure proper implantation of tracheal tubes, used to ventilate the lungs during procedures. Galveston, TX's Prospira recently received $50,000 from the Sheikh Zayed Institute for Pediatric Surgical Innovation for its developmental device to track the positioning of endotracheal tubes using optoacoustic imaging. Pediatric patients are at high risk, especially when being transported between hospitals, because they have a short trachea.
And Medtronic ($MDT) in November announced the acquisition of Scottish video laryngoscope maker Aircraft Medical for $110 million in cash.
- here's the safety alert
- more from the FDA
- here's the recall in the FDA database