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IntraClude Intra-Aortic Occlusion Device (2015-05-08)
- Starting date:
- May 8, 2015
- Posting date:
- June 15, 2015
- 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-53775
Recalled Products
- IntraClude Intra-Aortic Occlusion Device
Reason
Edwards Lifesciences has identified a potential safety risk which may occur during the use of the intraclude intra-aortic occlusion device (ICF100), used in cardiopulmonary bypass surgery. Edwards has received a limited number of reports regarding device damage on the strain relief near the hub area. Some of the reports have also indicated blood leakage in this area. When damage exists, blood loss can occur because blood can fill the device between the lumen shaft and the strain relief and leak from the area. No injuries or blood transfusions have been reported. In a worst case scenario with no mitigation, blood loss can occur during use of the device.
Affected products
A. 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
California
UNITED STATES