FDA: Medtronic’s Shiley trach tube recall is Class I

The FDA classified Medtronic‘s (NYSE:MDT) recall of certain lots of its Shiley neonatal and pediatric tracheostomy tubes as Class I, the most serious type of recall issued by the federal watchdog.
A Class I label from the FDA indicates that “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The recalled tracheostomy tubes were formed with a wider-angle bend than standard models, Fridley, Minn.-based Medtronic said. The company received reports that patients switching tubes from a previous Shiley model to a newer model experienced airway obstructions due to the wider-angle, according to the FDA. Obstructions in the airway can cause dangerous oxygen deprivation and carbon dioxide saturation issues in patients.
Medtronic announced the recall last month, and said it began notifying hospitals and distributors worldwide of the issue on May 8.
The FDA has received 12 reports of serious injuries due to the issue, but no deaths have been reported.
The recall affects 8,192 devices manufactured and distributed between May 2, 2013 and April 27, 2015, to the FDA. The lot numbers affected can be found in the FDA’s post on the recall.
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Source: Mass Device - July 16, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Recalls Respiratory medtronic Source Type: news