FDAMay 5, 2015device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential device damage on the strain relief near the hub area, which may result in blood leakage.
What to do
FDA enforcement status: Terminated
Brands named
edwards lifesciencesedwards
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAEdwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO2026-03-27
- FDACytal Burn Matrix 10x15 cm. Product ID: BMM1015.2026-03-19
- FDACytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.2026-03-19
- FDACytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.2026-03-19
- FDACytal Burn Matrix 7x10 cm. Product ID: BMM0710.2026-03-19
- FDACytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.2026-03-19
- FDACUSA Clarity C7000 Console, Software Version: 2.1.1.909. Ultrasonic surgical aspirator system.2026-03-06
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