Medical Devices

Halyard Health, KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes - Component May Detach During Use

Recall Class:  Class I

Date Recall Initiated: November 17, 2014

Devices: KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes

Use: An endotracheal tube is a plastic tube that is inserted into the windpipe (trachea) through the mouth or nose to open an airway for mechanical breathing. An endotracheal tube can also be used to remove fluid that builds up in the windpipe during a procedure.

Recalling Firm:
Halyard Health (formerly Kimberly-Clark Health Care)
1400 Holcomb Bridge Road
Roswell, Georgia 30076

Reason for Recall:

The cuff inflation line of certain KimVent* Microcuff* Endotracheal tubes may detach from the tube during use (if pulled, tugged, or excess tube/patient movement occurs). If the inflation line detaches, the cuff will gradually deflate. This may lead to an air leak between the cuff and the tracheal wall, which in turn may reduce the amount of air that reaches the lungs.

The firm received 19 reports where the device malfunctioned. In most cases the problem was identified immediately, while in other cases, it was identified when ventilator alarms went off. Most patients required reinsertion of endotracheal tubes.

Use of this recalled product could cause serious health risks, including delayed patient treatment, breathing difficulties, and death.

Public Contact: For questions about this recall, contact Halyard Regulatory Affairs at 770-587-7400.

FDA District: Atlanta District Office

More Information about this Recall: 

On November 17, 2014, Halyard Health sent customers an Urgent: Voluntary Product Recall. The letter described the product, problem, and actions to be taken.  

Customers who have this product in their inventory should:

Stop using all unused recalled devices and quarantine them.

  • Physicians: Complete the End-User Customer Product Recall Response Form that was included with the recall letter. Fax it to: 678-254-0391 within five business days of receipt of this letter. Respond even if there is no inventory. If your facility contains the recalled devices, a Halyard Health representative will provide return information.
    • NOTE: If any of these affected codes are currently being used on a patient, use discretion to determine any appropriate actions. If there are questions, contact the Halyard Health Medical Officer at 770-587-7400.
  • Distributors: Complete the Distributor Product Recall Response Form that was included with the recall letter. Fax it to: 678-254-0391 within five business days of receipt of this letter. Respond even if there is no inventory. If your facility contains the recalled devices, a Halyard Health representative will provide return information. 

About Class I Recalls:

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Page Last Updated: 01/05/2015
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