Home / Recalls / Sorin Group Italia S.r.l. / Z-2988-2020

Z-2988-2020 Class II Terminated

Recalled by Sorin Group Italia S.r.l. — Saluggia, N/A

FDA device recall Z-2988-2020 was initiated by Sorin Group Italia S.r.l. on July 29, 2020 and is designated Class II. 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 Pe… The recall status is terminated (terminated May 17, 2021). Affected quantity: 498 units (component in kits 1-4).

Recall Details

Product Type: Devices
Report Date: September 30, 2020
Initiation Date: July 29, 2020
Termination Date: May 17, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 498 units (component in kits 1-4)

Product Description

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.

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.

Distribution Pattern

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.

Code Information

Lot: 2002130166

Other recalls by Sorin Group Italia S.r.l.

Z-2987-2020 Class II — Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, C (July 29, 2020)
Z-2984-2020 Class II — Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, C (July 29, 2020)
Z-2986-2020 Class II — Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE (July 29, 2020)
Z-2985-2020 Class II — Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE (July 29, 2020)
Z-0805-2014 Class II — ORCHESTRA/ORCHESTRA PLUS Programmer (November 20, 2013)