Edwards IntraClude Intra-Aortic Occlusion Device Recalled for Potential Leak
Edwards Lifesciences is recalling 3,052 IntraClude Intra-Aortic Occlusion Devices due to a possible leak at the distal open end of the strain relief.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential leak in a medical device used for aortic occlusion, which poses a risk of harm if the device fails to maintain pressure, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Edwards Lifesciences, LLC is recalling 3,052 units of the IntraClude Intra-Aortic Occlusion Device, Model Number ICF100. The device is designed to occlude the ascending aorta and is packaged in a sterile barrier system.
The recall is due to a possible leak at the distal open end of the strain relief. This defect may cause medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta.
The affected units were distributed worldwide, including in the United States and various international countries. Specific lot numbers are listed in the agency's recall record. Healthcare facilities should contact Edwards Lifesciences for instructions on how to handle the recalled devices.
The recalled product
- Product
- Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. Designed to occlude the ascending aorta.
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Cardiovascular
- Affected units
- 3,052
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot No. 60876468
- 60850885
- 6060850886
- 60850888
- 60850889
- 60850890
- 60887217
- 60887218
- 60887219
- 60887220
- 60930494
- 60934623
- 60934624
- 60934625
- 60972889
- 60972890
- 60972892
- 61014406
- 61014408
- 61014410
Distribution
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