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Sorin Group Italia S.r.l Recalls
6 recalls on record · January 29, 2014 to September 30, 2020 · Medical Devices
Recalls by year
14
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 30, 2020Medical DevicesFDA
Sorin Group Italia S.r.l. recalls Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - Product Usage: he Dual
Hazard: 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.
September 30, 2020Medical DevicesFDA
Sorin Group Italia S.r.l. recalls Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - Product Usage: h
Hazard: 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.
September 30, 2020Medical DevicesFDA
Sorin Group Italia S.r.l. recalls Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - Product Usage: he
Hazard: 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.
September 30, 2020Medical DevicesFDA
Sorin Group Italia S.r.l. recalls Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE, UDI: 8022057015228 - Product Usage: he
Hazard: 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.
September 30, 2020Medical DevicesFDA
Sorin Group Italia S.r.l. recalls Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - Product Usage:
Hazard: 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.
January 29, 2014Medical DevicesFDA
Sorin Group Italia S.r.l. recalls ORCHESTRA/ORCHESTRA PLUS Programmer
Hazard: Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its programmer (ORCHESTRA or ORCHESTRA PLUS) during a follow-up exam of patients implanted with a REPLY or ESPRIT pacemaker.