Health product recall

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

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

IntraClude Intra-Aortic Occlusion Device

Lot or serial number

All lots.

Model or catalog number

ICF100

Companies
Manufacturer

Edwards Lifesciences LLC

1 Edwards Way

Irvine

92614

California

UNITED STATES