Medtronic this week voluntarily recalled more than 70,000 tracheostomy tubes for babies and children. There were reports that some patients were having a hard time breathing with the tubes.
Several hundred adverse events were reported that involved the Covidien Shiley tube since 2012. It was at that time that the product was changed to give it a different angle. Changing back to tracheostomy tubes with the old design seemed to resolve the issue, Medtronic stated.
Medtronic told the media that it has enough tubes made before 2012 to meet the demand for the eight types of tube under recall. The firm began to notify health care organizations in early May that they should cease use of the tubes.
FDA reported that many of the adverse events related to the tube suddenly experiencing a loss of air pressure. In early March, for example, there was an unexpected deflation with a patient who was on a ventilator in an ICU.
Medtronic added this week that there were 12 serious injuries to patients, which is what led to the recall. The patients experienced difficulty breathing, which had an immediate impact on oxygen levels. However, the spokesman for the firm stated that ‘a serious patient injury’ is defined merely as ‘discomfort,’ and that there were no reports of any permanent impairment of patients.