Health product recall

IntraClude Intra-aortic Occlusion Device (2019-05-22)

Starting date:
May 22, 2019
Posting date:
July 16, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-70435

Last updated: 2019-07-16

Affected 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 (Model ICF100, UDI code (01) 00690103190007).  Edwards Lifesciences has received a limited number of customer reports regarding balloon rupture during use of the device, and to ensure patient safety, Edwards is recalling certain IntraClude lots for which balloon rupture may be more likely.

Affected products

IntraClude Intra-aortic Occlusion Device

Lot or serial number

60972890
61078031
61097633
61139239
61259627
61259628
61713218
61723505
61898939

Model or catalog number

ICF100

Companies
Manufacturer

Edwards Lifesciences LLC

1 Edwards Way

Irvine

92614

California

UNITED STATES