—#150822

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.

FDA product code: LWR — Heart-Valve, Non-Allograft Tissue
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P150011
Affected lot / code info: All Lots

Why it was recalled

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

Root cause (FDA determination)

Use error

Action the firm took

The firm, LivaNova, sent a "Customer Letter" dated 10/31/2016 to its Consignees with clarifications about the implant of the Perceval Sutureless Aortic Valve. The letter described the product, problem and actions to be taken. The consignees were instructed to reinforce the steps that may influence procedural success and mitigate potential complications and complete and return the Customer Response Form via fax to: LivaNova Canada Corp, Canada at +1 303 895 2335 or email to: HV.FEEDBACK@LIVANOVA.COM. If you have additional questions or request of clarifications, please contact your LivaNova representative or Customer Service. For questions regarding this customer letter, please contact your LivaNova sales representative or email: hv.feedback@livanova.com.

Recalling firm

Firm: Sorin Group USA, Inc.
Address: 14401 W 65th Way, Arvada, Colorado 80004-3503

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2016-10-31
Terminated: 2017-11-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150822. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.