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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 VALVE see related information
Date Initiated by Firm July 29, 2020
Create Date September 18, 2020
Recall Status1 Terminated 3 on May 17, 2021
Recall Number Z-2988-2020
Recall Event ID 86161
Product Classification heart-valve, non-allograft tissue - Product Code LWR
Product Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation.
Code Information Lot: 2002130166
Recalling Firm/
Manufacturer		 Sorin Group Italia S.r.l.
Via Crescentino Sn
Saluggia Italy
Manufacturer Reason
for Recall		 LivaNova received complaints indicating the impossibility to collapse Perceval valve during procedure. The Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. The issue is relevant to specific lots of Dual Collapser size S/M.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Letter titled, Urgent Medial Device Removal, Perceval single-use accessory kit models assembly error, HV-SAL-2020-1, dated July 29, 2020 was sent to consignees via 1st class mail (certified return receipt) on July 29th, 2020 ¿ Informing the affected customers: o It could be impossible to collapse Perceval Sutureless heart valves (Perceval S and Perceval PLUS) while using specific lots of Perceval single-use accessory kits. The issue potentially affects kits assembled with a specific supplier lot; Actions to be taken by the Physician LivaNova is coordinating the removal and replacement of all potentially affected Perceval single use accessory kit lots in your inventory. Please ensure timely execution of the following actions: 1. Using the list provided in Attachment 1, please check your inventory for potentially affected devices supplied to your facility; 2. All potentially affected devices listed in Attachment 1 and still in inventory should not be used and should be quarantined, pending return of the devices to LivaNova; 3. Please complete and return the Attachment 1 by e-mail to LivaNova.FSCA@livanova.com to initiate the removal/replacement process of the Perceval single-use accessory kit(s). Your LivaNova Representative will contact you to coordinate replacement of the potentially defective device(s) if they have not already been used. Actions to be taken by the Company 1. Notification of the potentially affected devices removal via letter to inform users of the issue and advise them not to use and quarantine the potentially affected devices immediately; 2. Coordinating and providing information to the user on product replacement.Transmission of this Communication Please ensure that this notice is communicated to all personnel within your organization who need to be aware. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action. Please report all device-re
Quantity in Commerce 498 units (component in kits 1-4)
Distribution US Nationwide distribution including in the states of CA, FL, ID, ME, MN, MO, MS, NC, SD, OH, OR, PA, SD, TN, TX, VA, WA, WI and the countries of Canada, Japan, Germany, Netherland, Switzerland, Sweden, UK, Spain, Italy, France, Belgium, Finland, Greece, Slovenia, Malta, Poland, Romania, Croatia, Hungary, Serbia, Australia, Israel, Georgia, Iran, Kuwait, Oman, Quatar, Singapore, Thailand, Taiwan, Russia, South Africa.
Total Product Life Cycle TPLC 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.
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