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