Recall Z-0409-2024— Edwards Lifesciences, LLC
Class II · Ongoing
Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2023-10-04. It names one FDA 510(k) clearance: K152980. Product: Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.. Reason: Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer..
- Recalling firm
- Edwards Lifesciences, LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-10-04
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring.
Reason for recall
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Data sourced from openFDA. This site is unofficial and independent of the FDA.