Sorin Group Italia S.r.l.
FDA Regulatory Profile
Summary
- Total Recalls
- 6
- 510(k) Clearances
- 61
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2985-2020 | Class II | Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE, UDI: 8022057015228 | July 29, 2020 |
| Z-2987-2020 | Class II | Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 802205701525 | July 29, 2020 |
| Z-2984-2020 | Class II | Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 80220570152 | July 29, 2020 |
| Z-2988-2020 | Class II | Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - Pr | July 29, 2020 |
| Z-2986-2020 | Class II | Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 | July 29, 2020 |
| Z-0805-2014 | Class II | ORCHESTRA/ORCHESTRA PLUS Programmer | November 20, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K253671 | Dual Stage Venous Cannulae | January 30, 2026 |
| K251783 | Inspire HCR and HCR DUAL cardiotomy reservoirs | December 22, 2025 |
| K253616 | ProtekDilate Vascular Access Kit | December 19, 2025 |
| K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) | June 27, 2025 |
| K250150 | VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardiopleg | May 30, 2025 |
| K243264 | DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) | April 25, 2025 |
| K242953 | KIDS Arterial Filters | December 20, 2024 |
| K242092 | MICRO Arterial Filters | November 18, 2024 |
| K241236 | XTRA Collection sets; XTRA Sequestration set X | August 16, 2024 |
| K240584 | XTRA Autotransfusion System (with XTRA Bowl sets) | April 29, 2024 |
| K240193 | R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R50 | February 22, 2024 |
| K231652 | D100 KIDS; D101 KIDS | November 16, 2023 |
| K223361 | BMR 1900 PHISIO | June 10, 2023 |
| K211495 | EOS PMP | July 12, 2021 |
| K200612 | R501 aortic root cannula without vent line, R502 aortic root cannula with vent line | November 17, 2020 |
| K201916 | Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxyg | August 13, 2020 |
| K200683 | INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygena | June 12, 2020 |
| K190650 | Revolution Centrifugal Blood Pump | August 7, 2019 |
| K190690 | INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M | April 13, 2019 |
| K180979 | PureFlex Arterial Cannulae | November 16, 2018 |