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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 6 of 6 Results
Related Medical Device Recalls
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Z-0409-2024 - Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring. 2 11/29/2023 Edwards Lifesciences, LLC
Z-0410-2024 - Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring. 2 11/29/2023 Edwards Lifesciences, LLC
Z-0414-2024 - TruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm); PXVK0853: x3 (3cc)/VAMP 76in (193cm); PXVK0996:(3cc... 2 11/29/2023 Edwards Lifesciences, LLC
Z-0412-2024 - FloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For use in intravascular pressure monitoring. 2 11/29/2023 Edwards Lifesciences, LLC
Z-0413-2024 - TruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm), PX272: 3 cc/72in (180cm), PX284: 3 cc/84 in (210 cm), PX2X2: x2 (3cc), PX3X3284C: X3 (3cc), PX4X4: x4 (3cc), PX... 2 11/29/2023 Edwards Lifesciences, LLC
Z-0411-2024 - FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring. 2 11/29/2023 Edwards Lifesciences, LLC
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