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