Medtronic Inc. has recalled a breathing tube used during surgery that could collapse and imperil a patient’s breathing if handled incorrectly, the Food and Drug Administration said Friday.
It was the first public mention of the problem but the Fridley-based medical device marker said the recall was begun in March and completed in April, and that no deaths or injuries were reported. The product, called a NIM Trivantage EMG Endotracheal Tube, was manufactured at Medtronic’s Jacksonville, Fla., operations.
The FDA announced the recall on its website Friday because it had classified the recall’s degree of seriousness. It was classified a Class One recall, which the FDA said on its website means “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The endotracheal tube is used during surgery for ventilation and for monitoring the muscles of the voice box. A cuff around the tube, used to close the gap around the tube that delivers air and anesthesia, can become deflated if the device is handled incorrectly. This may require a doctor to reinflate the cuff or replace the tube to make sure the patient can continue to breathe.
“We have confirmed with all customers [doctors and hospitals] that they either have returned or are returning that product,” Medtronic spokeswoman Cindy Resman said in an interview Friday.
“No customer needs to think that this is a new issue, or that there is something left to do.”