RecallHawk

Edwards Lifesciences

15 FDA actions

ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLI

Edwards Lifesciences

Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts

Edwards Lifesciences

Edwards eSheath+ introducer set

Edwards Lifesciences

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)

Edwards Lifesciences

HemoSphere Stream Module

Edwards Lifesciences

Edwards eSheath Optima introducer set

Edwards Lifesciences

HemoSphere Advanced Monitor (HEM1); HemoSphere Technology Module (HEMTOM10); HemoSphere ClearSight Module (HEMCSM10); Sm

Edwards Lifesciences

Edwards eSheath Optima introducer set

Edwards Lifesciences

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC

Edwards Lifesciences

Cerebral Autoregulation Index (CAI) Algorithm

Edwards Lifesciences

Fogarty Fortis Arterial Embolectomy Catheter

Edwards Lifesciences

Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D

Edwards Lifesciences

Fogarty Arterial Embolectomy Catheter with Gate Valve

Edwards Lifesciences

Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters

Edwards Lifesciences

EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA,

Edwards Lifesciences