Medtronic Recalls Neonatal, Pediatric and Long Tracheostomy Tubes

Medtronic has announced a voluntary recall of its cuffless Covidien Shiley Neonatal, Pediatric and Long Tracheostomy Tube and Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGuard Cuff. The recall follows reports of users experiencing discomfort and breathing difficulties. Twelve reports of serious injury have been received.

If a resident is using one of the affected products and not experiencing any difficulty, Medtronic recommends consulting with the physician to see whether the tube should be replaced immediately or at the next scheduled interval.

Facilities should review their inventory and segregate any affected products and return them directly to Medtronic, if that is how they were purchased, or to the distributor who sold them.

The affected item numbers that are available from ProMed are:

• 4.5 PEF (ProMed item number 109-4.5PEF)
• 5.5PEF (ProMed item number 109-5.5PEF)

To download the recall paperwork, click on the product links above and then select the Clinical Documentation tab (login is required). 

If you have any questions, please give us a call at (800) 648-5190.