ENDOTRACHEAL TUBE (2016-06-28)

Starting date:

June 28, 2016

Posting date:

July 22, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-59474

• 
  Reason
• 
  Affected products

Affected products

A. ENDOTRACHEAL TUBE

Reason

Medtronic has received complaint reports of "wire through lumen", "cuff leakage" or some variation where a wire was found out of place or to have penetrated the channel wall. Most of these reports do not indicate patient injury or adverse health consequences.Therefore, and to ensure patient safety and out of an abundance of caution, Medtronic is providing a technical bulletin to reinforce and remind customers of the proper handling of the tube during intubation, appropriate warnings and precautions that could relate to the complaints and that are included in the instructions for use (IFU).

Affected products