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Avanos Medical Inc Recalls Certain BALLARD ACCESS Closed Suction Systems for Neonates/Pediatrics for Risk of Inadequate Ventilation, Other Injuries from Cracked Manifolds
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Sep 28, 2023Medtronic Recalls NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tube for Risk of Airway Obstruction
Aug 27, 2023The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tubes are used during surgery to:
Medtronic is recalling the NIM CONTACT Reinforced EMG Endotracheal Tube and the NIM Standard Reinforced EMG Endotracheal Tubes after receiving customer complaints about obstruction of the endotracheal tube while in use in patients. If the tube obstructs, ventilation failure can occur.
If the tube does not ventilate properly or obstructs the airway, patients may suffer oxygen deprivation, brain damage, or death.
Medtronic reported that they have received 15 complaints, three injuries, and two deaths associated with this issue between March 31, 2020, and March 31, 2022.
On April 29, 2022, Medtronic issued an Urgent Medical Device Safety Notice to anesthesia care providers and other users of these products. The letter emphasized the importance of following the instructions for use (IFU) and avoiding overinflation of the product’s silicone cuff to prevent airway obstruction.
Additionally, the letter advised providers to:
The letter also offered recommended actions for care providers if an airway obstruction occurs:
Medtronic also noted that an update to the current instructions reinforcing these warnings and precautions will be mailed to customers.
Prior to this recall, the FDA issued a related Letter to Health Care Providers about the Potential Risk of Airway Obstruction When Using Certain Electromyogram Endotracheal Tubes.
Customers with questions or concerns about this recall are asked to contact their Medtronic Representative.
Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.
09/12/2022