Z-0716-2017Class II

Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart...

Name: Z-0716-2017 Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart...
Creator: Sorin Group USA, Inc.
Published: 2016-10-31
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2016-10-31 / Terminated

FDA source

Sorin Group USA, Inc. began a recall of Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval... on 2016-10-31. FDA classified it as Class II and gives the reason as "Sorin Group USA, Inc. announces a voluntary field action for the Perceval Sutureless Heart Valve due to updated steps associated with the implantation procedure". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0716-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-31
Posted: 2016-12-07
Terminated: 2017-11-03
Recalling firm: LivaNova USA, Inc.
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.
Product code: LWR Heart-Valve, Non-Allograft Tissue
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 root cause: Use error
Action: 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: [email protected]. 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: [email protected].
Quantity in commerce: 845 units
Distribution: 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.
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0716-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0716-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-14	2016-12-07

Product code LWR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)