Z-2988-2020Class II

Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 -

Name: Z-2988-2020 Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 -
Creator: Sorin Group Italia S.r.l.
Published: 2020-07-29
License: https://open.fda.gov/license/

Corcym Inc. / initiated 2020-07-29 / Terminated / root cause: manufacturing process

FDA source

Sorin Group Italia S.r.l. began a recall of 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... on 2020-07-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2988-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-29
Posted: 2020-09-18
Terminated: 2021-05-17
Recalling firm: Corcym Inc.
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.
Product code: LWR Heart-Valve, Non-Allograft Tissue
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.
Root cause tag: manufacturing process
FDA root cause: 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 [email protected] 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.
Product codes and lots: Lot: 2002130166

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2988-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2984-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-18
Z-2985-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-18
Z-2986-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-18
Z-2987-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-18
Z-2988-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-18

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)