Biosense Webster, Inc.

All lots manufactured as of February 24, 2015 are affected.

Cardiovascular Devices

2

No

Nationwide Distribution

LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06. || LASSO NAV DUO LOOP eco Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. The catheter is designed to obtain electrograms in the atrial regions of the heart. LASSO NAV DUO LOOP eco Catheter provides location information when used with compatible CARTO 3 EP Navigation Systems.

SMARTABLATE System Serial No. G4C-0296, G4C-0297, G4C-0272, G4C-0262, G4C-0232, G4C-0090.  System Serial No. G4C-0076, G4C-0195, G4C-0064, G4C-0047, G4C-0159, G4C-0187, G4C-0146, G4C-0140, G4C-0037, G4C-0131, G4C-0031, G0054.

Cardiovascular Devices

3

No

Worldwide Distribution - US Nationwide in the state of: CA, IL, KY, NJ, PA and the countries of: Czech Republic, Denmark, Finland, France, Germany, and Sweden.

SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. || Product Usage: || The use of the SMART ABLATE Generator and all accessories is indicated in combination with compatible therapeutic catheters for use in conventional intracardiac RF ablation procedures. The SMARTABLATE Foot Pedal is designed to initiate or discontinue operation of the SMARTABLATE System. The Foot Pedal can be connected to the SMARTABLATE RF Generator, SMARTABLATE Irrigation Pump; or SMARTABLATE Remote Control.

Product code (Product Description) (GTIN): D-1282-01-S (NAV, 7FR, F, 4-4-4) (10846835009576), D-1282-02-S (NAV, 7FR, F, 2-6-2) (10846835009583), D-1282-03-S (NAV, 7FR, F, 1-8-1) (10846835009590), D-1282-04-S (NAV, 7FR, D, 4-4-4) (10846835009606), D-1282-05-S (NAV, 7FR, D, 2-6-2) (10846835009613), D-1282-06-S (NAV, 7FR, D, 1-8-1) (10846835009620).

Cardiovascular Devices

2

No

Nationwide Distributed internationally to Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Republic of Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Oman, People's Republic of China, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.

PENTARAY NAV High-Density Mapping Catheter.

Product Codes M490006, M490007

Cardiovascular Devices

3

No

Distributed to the following states: CA, CO, GA, IL, IN, MI, NM, NY, OH, PA, TN, TX, UT, WA, WI. Product was also distributed to the following countries: Germany, France, Austria, Sweden Italy, Belgium, Denmark, and Singapore.

SMARTABLATE RF System Generator

Product code (Product Description) (GTIN): D-1282-07-S (NAV ECO 7FR, F, 4-4-4) (10846835012217), D-1282-08-S (NAV ECO 7FR, F, 2-6-2) (10846835012224), D-1282-09-S (NAV ECO 7FR, F, 1-8-1) (10846835012231), D-1282-10-S (NAV ECO 7FR, D, 4-4-4) (10846835012248), D-1282-11-S (NAV ECO 7FR, D, 2-6-2) (10846835012255), D-1282-12-S (NAV ECO 7FR, D, 1-8-1) (1846835012262).

Cardiovascular Devices

2

No

Nationwide Distributed internationally to Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Republic of Korea, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, The Netherlands, New Zealand, Norway, Oman, People's Republic of China, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom.

PENTARAY NAV High-Density Mapping Catheter.