Recall Z-1929-2018— Edwards Lifesciences, LLC
Class II · Terminated
Class II FDA medical device recall by Edwards Lifesciences, LLC, initiated 2018-03-30, terminated 2023-11-29. It names one FDA 510(k) clearance: K163693. Product: Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. Designed to occlude the ascending aorta.. Reason: Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta..
- Recalling firm
- Edwards Lifesciences, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-30
- Terminated
- 2023-11-29
- Firm location
- Draper, UT, 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
Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. Designed to occlude the ascending aorta.
Reason for recall
Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta.
Data sourced from openFDA. This site is unofficial and independent of the FDA.