IntraClude Intra-Aortic Occlusion Device (2019-01-21)

Starting date:

January 21, 2019

Posting date:

March 8, 2019

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-69224

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  Reason
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  Affected products

Affected Products

IntraClude Intra-Aortic Occlusion Device

Reason

Edwards Lifesciences has received a limited number of customer reports regarding an interlumen leak between the cardioplegia lumen and pressure lumen in the device.

If present, the leak will be detected after the device is advanced into the ascending aorta, but before the balloon is inflated. The detection will occur when, as stated in the instructions for use, the aortic root vent is turned on, which is the last step prior to inflating the balloon. When present, the leak will result in aortic root pressure dropping to 0 mmHg or less due to the vacuum being pulled on the aortic root vent line.

Affected products