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The device was recalled by the company last year.
In February, the Edwards device was recalled because of "reports of clinically significant fluid imbalance," according to the recall alert.
But that same executive, it turns out, had supervised the implant's introduction in the United States and had been told by a top company consultant three years before the device was recalled that it was faulty.
Currently, the vast majority of medical devices are cleared for marketing without clinical testing or weighty evidence that they are safe and effective; a manufacturer simply has to show that its device is "substantially equivalent" to one that has previously been cleared — even if the earlier device was recalled by the manufacturer after safety problems.
Although not specific to a hospital setting, Maisel argued for a staged notification if a patient's medical device was recalled, where physicians were notified first by the manufacturer.
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The incident was reported to the local supplier and the manufacturer, and the defective batch of laryngeal mask airway devices was recalled.
All the devices were recalled in France earlier this year.
These devices were recalled by the Consumer Product Safety Commission CPSCC) on Oct. 13 and should no longer be used.
For medical-device alerts, we coded each device according to whether it was recalled or withdrawn from the market, and one author (MB) wrote to manufacturers of recalled devices to obtain further information.
Apple is offering a free rubber "bumper" to owners of the iPhone 4 to head off criticism over problems with its signal reception but dismissed suggestions that the device should be recalled.
And soon, implants will deliver drugs, alert doctors to the presence of infections and even send notifications if the device has been recalled.
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Since I tried Ludwig back in 2017, I have been constantly using it in both editing and translation. Ever since, I suggest it to my translators at ProSciEditing.

Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com