Product Wiki · Recalls · Health Canada — Medical Devices

IntraClude Intra-aortic Occlusion Device (2019-05-22) — recall 59786

Health Canada — Medical Devices · Canada · 2019-07-16 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
59786
Date of alert
2019-07-16
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: 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.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/intraclude-intra-aortic-occlus

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