Endologix Inc

MODEL NUMBER 34-34-80LE, LOTS W09-2967 AND W09-3000.

Cardiovascular Devices

3

No

Recalled devices were distributed to medical centers and hospitals in OR, PA, FL, TX, MI and LA.

Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80LE, LOTS W09-2967 AND W09-3000.

MODEL NUMBER 34-34-80L, LOTS W09-2966 AND W09-2998.

Cardiovascular Devices

3

No

Recalled devices were distributed to medical centers and hospitals in OR, PA, FL, TX, MI and LA.

Powerlink System with IntuiTrak Delivery System (Endovascular Graft): Model Number 34-34-80L, LOTS W09-2966 AND W09-2998.

Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845

Cardiovascular Devices

2

No

Worldwide Distribution - USA Nationwide in the states of: NY, NH, IN, MI, FL and NJ and in the countries of: Europe and Latin America.

Brand Name: AFX" Introducer System, Model Number S17-45. || Lot Numbers: 1079840, 1079843, 1079844, 1079845. || Product Usage: || The AFX Introducer System is intended for use to facilitate the introduction of catheters and other medical devices into the vasculature and to minimize blood loss associated with such introduction.

Lot Numbers: W06-0079, W06-0334, W06-0393, W06-0501, W06-0658, W06-0773, W06-0988 & W06-1196

Cardiovascular Devices

3

Yes

Worldwide, including USA and Germany.

Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft), Model Number 28-16-155BL

Lot Numbers: W06-0333, W06-0392, W06-0500, W06-0553, W06-0621, W06-1100 & W06-1152

Cardiovascular Devices

3

Yes

Worldwide, including USA and Germany.

Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft). Model Number 25-16-155BL