Health product recall

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