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U.S. Department of Health and Human Services

Class 2 Device Recall Perceval Sutureless Heart Valve

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 Class 2 Device Recall Perceval Sutureless Heart Valvesee related information
Date Initiated by FirmOctober 31, 2016
Create DateDecember 07, 2016
Recall Status1 Terminated 3 on November 03, 2017
Recall NumberZ-0716-2017
Recall Event ID 75570
PMA NumberP150011 
Product Classification heart-valve, non-allograft tissue - Product Code LWR
ProductPerceval 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.
Code Information All Lots
Recalling Firm/
Manufacturer		 Sorin Group USA, Inc.
14401 W 65th Way
Arvada CO 80004-3503
For Additional Information ContactJoan Ceasar
303-467-6306
Manufacturer Reason
for Recall		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 Determined
Cause 2		Use error
ActionThe 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.
Quantity in Commerce845 units
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = LWR
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