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

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  Reason
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  Affected products

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