Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device Recalled for Potential Damage
Edwards Lifesciences is recalling IntraClude Intra-Aortic Occlusion Devices due to potential damage near the hub that may cause blood leakage.
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 involves a medical device with a defect that may result in blood leakage, representing a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Edwards Lifesciences, LLC is recalling the IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. The recall involves 3,360 units that were distributed nationwide in the United States. The devices are packaged sterile and non-pyrogenic in a sealed, peel-type pouch and are intended for use in patients undergoing cardiopulmonary bypass.
The recall was initiated because of potential device damage on the strain relief near the hub area. This defect may result in blood leakage. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and consumers should stop using the affected devices immediately. The recall covers all lots within expiration, including specific lot numbers listed in the official FDA record Z-1758-2015. Users should contact Edwards Lifesciences for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch For use in patients undergoing cardiopulmonary bypass.
- Manufacturer
- Edwards Lifesciences, LLC
- Category
- Medical Device — Cardiovascular
- Affected units
- 3,360
Distribution
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