VentStar Helix heated, dual heated (2019-03-27)

Starting date:

March 27, 2019

Posting date:

April 9, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Hospitals, Healthcare Professionals

Identification number:

RA-69542

Last updated: 2019-04-09

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  Reason
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  Affected products

Affected Products

A. VentStar Helix dual heated

B. VentStar Helix heated

Reason

Several cases have come to Draeger's attention in which cracks have formed in the breathing hose during ventilation.  If a crack forms in the breathing hose during operation, a leak will result that can negatively affect ventilation of the patient. If the breathing circuit is used with devices listed as compatible in the Instructions for Use, any leakages will be detected and the device will give an alarm.

Affected products