Ventri

All sterile un-implanted stock manufactured prior to HW25838 is subject to removal.

Cardiovascular Devices

3

Yes

Worldwide Distribution - US, in the states of AL, AR, AZ, CA, DC, FL, IL, IN, KY, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, and WI; and, the countries of Argentina, Belarus, Bosnia, Herzegovina, Brazil, Canada, Chile, Colombia, Hong Kong, India, Israel, Kazakhstan, Kuwait, Lebanon, Malaysia, New Zealand, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Taiwan, Turkey, and Vietnam.

HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. || Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.

Cardiovascular Devices

3

Yes

Worldwide Distribution -- U.S., including the states of MN, PA, IL, WI, AZ, AR, TN, MO, TX, MA, NE, MI, CA, NC, OH, NY, GA, VA, FL, OK, MD, ME, SC, IN, LA, OR, WA, AL, CO, IA, KS, KY, UT, DC, and CT; and, the countries of Australia, Austria, Belgium, Brazil, Brunei, Canada, Cayman Islands, Colombia, Croatia, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Kuwait, Lebanon, Malaysia, Montenegro, Netherlands, Poland, Qatar, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom.

Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 || Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

REF 0010211 Lot DATB0015

General and Plastic Surgery Devices

2

Yes

Nationwide distribution

Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"), Warwick, RI || Product Code: 0010211 || The Ventrio Hernia Patch is a self-expanding non-absorbable, sterile prosthesis, containing two primary layers of monofilament polypropylene mesh stitched with PTFE monofilament to an ePTFE sheet, forming a positioning pocket. The Ventrio Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

1010344, 1011451, 1021637, 1030061, 1032742, 1040738, 1041561, 1052595, 1053121, 1053487, 1080115, 1080148, 1081155, 1082137

Neurological Devices

2

Yes

Worldwide Distribution - USA (nationwide) and the countries of Austria, Canada, Italy, Australia

"***REF NL78013-01***INTEGRA NEUROSCIENCES***Stylet for Ventricular Catheter***Non Sterile for Single Use Only***Size 0.031" OD, Total Length: 8"***Plainsboro, NJ***" || Stainless steel stylet for ventricular catheter

GE: Discovery NM 530c, Ventri