Sorin Group USA, Inc. recalls Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M,

Recalled December 14, 2016 · FDA recall Z-0716-2017 · Sorin Group USA

Hazard

Sorin Group USA, Inc. announces a voluntary field action for the Perceval Sutureless Heart Valve due to updated steps associated with the implantation procedure. · FDA Class II

Units

845 units

Sold at

Worldwide Distribution-US (Nationwide) including states of: MD, ME, MA, NH, NY, NJ, AL, MS, VA, FL, CA, HI, TN, GA, WI, TX, MI, OH, KS, MN, NC, IL, IN, WA MO, PA, NM, and UT and countries of: Austria, Australia, Belgium, Bulgaria, Brazil, Canada, Chile, Colombia, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Jordan, India, Italy, Iran, Islamic Republic of, Ireland, Israel, Korea, Republic of, Kuwait, Luxembourg, Malaysia, Malta, Mexico, Netherland, New Zealand, Norway, Panama, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South African, Spain, Switzerland, Romania, Russian Federation,Taiwan, Province of China, Thailand, Turkey, United Arab Emirates, United Kingdom, and Uruguay.

Description

Sorin Group USA, Inc. announces a voluntary field action for the Perceval Sutureless Heart Valve due to updated steps associated with the implantation procedure.

Product

Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart Valve size L, Item # ICV1210, REF PVS25; Perceval Sutureless Aortic Heart Valve size XL, Item # ICV1211, REF PVS27. The Perceval bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.

Manufacturer(s)

Sorin Group USA, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →