IntraClude Intra-aortic Occlusion Device (2018-04-02)
- Starting date:
- April 2, 2018
- Posting date:
- May 18, 2018
- 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-66778
Affected products
IntraClude Intra-aortic Occlusion Device
Reason
Edwards Lifesciences has received a limited number of reports (11 reports since December 2017, which is a rate of approximately 2%) regarding inflation fluid leaking out the distal open end of the strain relief. When present, this leak can be identified through normal monitoring of balloon pressure, and it causes the medical staff to continue adding inflation fluid to the balloon, typically about 2-5 ml every 10-15 minutes for up to 50 ml total, to maintain balloon pressure sufficient for adequate occlusion of the ascending aorta.
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
UNITED STATES