Sorin Group Italia S.R.L.
Sorin Group Italia S.R.L. holds FDA 510(k) medical device clearances, first cleared 1995, most recent 2026, with 6 FDA device recalls on record.
Top product codes for Sorin Group Italia S.R.L.
FDA recalls by Sorin Group Italia S.R.L.
- Z-2985-2020 — Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE, UDI: 8022057015228 - 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.
- Z-2987-2020 — Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - 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.
- Z-2984-2020 — Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - 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.
- Z-2986-2020 — Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - 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.
- Z-2988-2020 — 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.
- Z-0805-2014 — ORCHESTRA/ORCHESTRA PLUS Programmer
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Sorin Group Italia S.R.L.
- K253671 — Dual Stage Venous Cannulae
- K251783 — Inspire HCR and HCR DUAL cardiotomy reservoirs
- K253616 — ProtekDilate Vascular Access Kit
- K250610 — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)
- K250150 — VANGUARD Blood cardioplegia Systems (3 models)
- K243264 — DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)
- K242953 — KIDS Arterial Filters
- K242092 — MICRO Arterial Filters
- K241236 — XTRA Collection sets; XTRA Sequestration set X
- K240584 — XTRA Autotransfusion System (with XTRA Bowl sets)
- K240193 — R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26)
- K231652 — D100 KIDS; D101 KIDS
- K223361 — BMR 1900 PHISIO
- K211495 — EOS PMP
- K200612 — R501 aortic root cannula without vent line, R502 aortic root cannula with vent line
- K201916 — Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator
- K200683 — INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir
- K190650 — Revolution Centrifugal Blood Pump
- K190690 — INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir
- K180979 — PureFlex Arterial Cannulae
- K180411 — MEMO 4D
- K180448 — INSPIRE 6M Hollow Fiber Oxygenator +3 more
- K162215 — Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae
- K161733 — INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
- K151713 — LILLIPUP PMP, LILLIPUT PMP INTEGRATED
- K150489 — EOS PMP, EOS PMP Integrated
- K142221 — MEMO 3D ReChord
- K131103 — XRES BLOOD COLLECTION RESERVOIR XRES 120MICROMETER BLOOD COLLECTION RESERVOIR
- K130433 — INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL RESERVOIR, INSPIRE 8F HOLLOW FIBER OXYGENATOR WITH INTEGRATE
- K130209 — INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDHELL RESERVOIR, INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED
- K122844 — INSPIRE 8F DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL RESERVOIR
- K122254 — INSPIRE 8 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
- K121536 — INSPIRE 8F OXYGENATOR WITH INTEGRATED ARTERIAL FILTER & HARDSHELL RESERVOIR
- K121909 — INSPIRE 6 DUAL HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVIOR
- K121229 — INSPIRE 8 DUAL HOLLOW FIBER OXYGENATOR WITH WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY
- K120185 — INSPIRE 6F HOLLOW FIBER OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND HARDSHELL VENOUS/CARDIOTOMY RESERVIOR
- K113626 — INSPIRE 6 HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR
- K112771 — BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG
- K112245 — XTRA
- K110782 — XVAC
- K103202 — PREASSEMBLED SURGICAL WASH SET
- K101586 — XTRA AUTOTRANSFUSION SYSTEM
- K100507 — XRES BLOOD COLLECTION RESERVOIR
- K093986 — AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS
- K093601 — AF 840 PH.I.S.I.O. ARTERIAL FILTER
- K092895 — APEX HP M ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
- K092315 — SORIN VVR 4000I AND 4000I SMARXT FILTERED HARDSHELL VENOUS RESERVOIR
- K081313 — SH14 HEMOCONCENTRATOR
- K083021 — APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATOR
- K073380 — SYNTHESIS PH.I.S.I.O. ADULT MEMBRANE OXYGENATOR WITH INTEGRATED ARETERIAL FILTER AND HARDSHELL VENOUS/CARIOTOMY RESERVOI
- K072091 — D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR
- K072308 — D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED
- K063255 — D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED
- K061527 — CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING
- K061031 — D 100 L001 PH.I.S.I.O.: NEWBORN HOLLOW FIBER MEMBRANE OXYGENATOR WITH INTEGRATED HARDSHELL CARDIOTOMY/VENOUS RESERVOIR W
- K030231 — CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON
- K010974 — RETROGRADE CARDIOPLEGIA CANNULA, MANUAL-INFLATING, WITH MALLEABLE OR GUIDWIRE STYLET
- K002019 — RETROGRADE CARDIOPLEGIA CANNULA, SELF-INFLATING, WITH MALLEABLE OR GUIDEWIRE STYLET
- K981601 — CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER
- K972503 — CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
- K943934 — AORTIC ARCH CANNULAS
Data sourced from openFDA. This site is unofficial and independent of the FDA.