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Sorin Group Italia S.R.L.

US Last updated 23 May 2026

Devices
61
Registries
FDA 510(k)EUDAMEDFDA
FDA recalls
6

Catalogue61

Page 1 of 2

Showing 1-50 of 61

FDA recalls6

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

  • 2020

    • 29 Jul 2020 Z-2984-2020 Class II Terminated 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.
    • 29 Jul 2020 Z-2985-2020 Class II Terminated 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.
    • 29 Jul 2020 Z-2986-2020 Class II Terminated 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.
    • 29 Jul 2020 Z-2987-2020 Class II Terminated 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.
    • 29 Jul 2020 Z-2988-2020 Class II Terminated 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.

  • 2013

    • 20 Nov 2013 Z-0805-2014 Class II Terminated 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.

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Sorin Group Italia S.R.L MIRANDOLA Modena · IT FEI 3005426550

What Sorin Group Italia S.R.L. makes

The company manufactures cardiovascular surgical and perfusion devices, including cardioplegia adapters, vessel and aortic root cannulae, autotransfusion systems with disposable bowl sets, and cardiotomy reservoirs with specialized coatings. Additional products include retrograde cardioplegia cannulae, arterial cannulae, centrifugal blood pumps, and venous reservoirs with integrated oxygenation or filtration. Membrane oxygenators with arterial filters and hard-shell reservoirs are also part of the portfolio, alongside venous return filters and perfusion circuit components like Easyflow and Easyflow Duo sets.

These devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. The portfolio is listed in the FDA’s 510(k) registry, reflecting compliance with U.S. medical device authorization requirements. The manufacturer operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
US