Device Recall EndoPlege

Lot No.: 718993, 718995, 718996, 718998, 718999, 719000, 719001, 739692, 739693, 742834, 742835, 747591, 751029, 751036, 751041, 755814, 755814A, 763115, 763119, 763123, 763125, 763127, 763128, 763129, 774333, 774334.

Cardiovascular Devices

2

No

Nationwide Distribution

EndoPlege Sinus Catheter Kit, REF EP, 9 Fr x 18.9", Contains Phthalates, Sterile EO, Sterile R, Edwards Lifesciences LLC, Irvine, CA 92614. || The EndoPlege coronary sinus catheter is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the EndoPlege coronary sinus catheter contamination guard, is packaged with these catheters