Sorin Group Italia S.r.l.

Country not established FDA

Devices: 61
Registrations: FDA
FDA recalls: 6

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA establishment, FDA recalls

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.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue61

Newest first, rows 1-50 of 61

Search and filter all 61 devices

Rows 1-50 of 61

Showing 1-50 of 61

FDA recalls6

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 6 recalls initiated by Sorin Group Italia S.R.L., the earliest on 2013-11-20 and the most recent on 2020-07-29. By recorded status: 6 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

2017 0
2018 0
2019 0
2020 5
2021 0
2022 0
2023 0
2024 0
2025 0
2026 0

1 initiated before 2017

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. Distribution: US Nationwide distribution including in the states of CA, FL, ID, ME, MN, MO, MS, NC, SD, OH, OR, PA, SD, TN, TX, VA,…
  Full distribution text
  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.
- 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. Distribution: US Nationwide distribution including in the states of CA, FL, ID, ME, MN, MO, MS, NC, SD, OH, OR, PA, SD, TN, TX, VA,…
  Full distribution text
  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.
- 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. Distribution: US Nationwide distribution including in the states of CA, FL, ID, ME, MN, MO, MS, NC, SD, OH, OR, PA, SD, TN, TX, VA,…
  Full distribution text
  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.
- 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. Distribution: US Nationwide distribution including in the states of CA, FL, ID, ME, MN, MO, MS, NC, SD, OH, OR, PA, SD, TN, TX, VA,…
  Full distribution text
  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.
- 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. Distribution: US Nationwide distribution including in the states of CA, FL, ID, ME, MN, MO, MS, NC, SD, OH, OR, PA, SD, TN, TX, VA,…
  Full distribution text
  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.
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. Distribution: Nationwide. Submission numbers: P950029S041, P980049S050, P060027S011, P980049S006

FDA establishments1

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

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

Frequently asked questions

How many devices does Sorin Group Italia S.R.L. have in the registry?

The registry currently lists 61 devices for Sorin Group Italia S.R.L.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sorin Group Italia S.R.L.'s devices?

Among its 50 most recently registered devices, Sorin Group Italia S.R.L. has devices listed in EUDAMED (1 device) and FDA 510(k) (50 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Sorin Group Italia S.R.L.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Sorin Group Italia S.R.L.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Sorin Group Italia S.R.L.?

FDA recall records list 6 recalls initiated by Sorin Group Italia S.R.L., the most recent initiated on 29 Jul 2020. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Sorin Group Italia S.R.L. in the registry?

The most recently registered devices listed for Sorin Group Italia S.R.L. include CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE, XTRA, XTRA Autotransfusion System (with XTRA Bowl sets) and CARD 43 CARDIOTOMY RESERVOIR WITH PHOSPHORYLCHOLINE COATING.

Which FDA establishments are linked to Sorin Group Italia S.R.L.?

1 FDA establishment is linked to Sorin Group Italia S.R.L. in the registry; they are listed on the company page.

Generated automatically from registry data and not verified by a human reviewer.

At a glance

Market reach

What Sorin Group Italia S.r.l. makes

Catalogue61

Cardioplegia Adapters, Vessel Canulae, And Aortic Root Cannulae Ref K972503

Xtra Ref K112245

XTRA Autotransfusion System (with XTRA Bowl sets) Ref K240584

Card 43 Cardiotomy Reservoir With Phosphorylcholine Coating Ref K061527

Retrograde Cardioplegia Cannula, Manual-Inflating, With Malleable Or Guidwire Stylet Ref K010974

PureFlex Arterial Cannulae Ref K180979

Revolution Centrifugal Blood Pump Ref K190650

Inspire HCR and HCR DUAL cardiotomy reservoirs Ref K251783

BMR1900 Ph.i.s.i.o Venous Reservoir Bag Ref K112771

Synthesis Ph.i.s.i.o. Adult Membrane Oxygenator With Integrated Areterial Filter And Hardshell Venous/Cariotomy Reservoi Ref K073380

Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) Ref K250610

Sorin Vvr 4000I And 4000I Smarxt Filtered Hardshell Venous Reservoir Ref K092315

ProtekDilate Vascular Access Kit Ref K253616

Apex Hp M Ph.i.s.i.o. Adult Hollow Fiber Membrane Oxygenator Ref K083021

Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae Ref K162215

D131 Ph.i.s.i.o Dideco Kids Infant Arterial Filter With 40 Micron Screen Phosphorycholine Coated Ref K072308

KIDS Arterial Filters Ref K242953

INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter Ref K180448

R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15; R502-20: R502-26) Ref K240193

VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini) Ref K250150

Inspire 8F Dual Hollow Fiber Oxygenator With Integrated Arterial Filter And Hardshell Reservoir Ref K122844

Xtra Autotransfusion System Ref K101586

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 Ref K190690

D 100 L001 Ph.i.s.i.o.: Newborn Hollow Fiber Membrane Oxygenator With Integrated Hardshell Cardiotomy/Venous Reservoir W Ref K061031

Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator Ref K201916

D101 Kids Infant Hollow Fiber Membrane Oxygenator With Integrated Hardshell Cardiotomy/Venous Reservoir Ref K072091

Coronary Artery Perfusion Cannula With Self-Inflating Balloon Ref K030231

XTRA Collection sets; XTRA Sequestration set X Ref K241236

DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14) Ref K243264

Inspire Svr 1200, Inspire 6F C, Inspire 8F C Ref K161733

Af 620 Ph.i.s.i.o., Af 640 Ph.i.s.i.o. Arterial Filters Ref K093986

Inspire 8F Oxygenator With Integrated Arterial Filter & Hardshell Reservoir Ref K121536

California Medical Laboratories Inc. Malleable Vent Catheter Ref K981601

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 Ref K200683

Apex Hp M Adult Hollow Fiber Membrane Oxygenator Ref K092895

Inspire 6 Dual Hollow Fiber Oxygenator With Integrated Hardshell Venous/Cardiotomy Reservior Ref K121909

Preassembled Surgical Wash Set Ref K103202

Xres Blood Collection Reservoir Xres 120MICROMETER Blood Collection Reservoir Ref K131103

MEMO 3D ReChord Ref K142221

Af 840 Ph.i.s.i.o. Arterial Filter Ref K093601

Inspire 8 Hollow Fiber Oxygenator With Integrated Hardshell Reservoir, Inspire 8F Hollow Fiber Oxygenator With Integrate Ref K130433

Eos Pmp Ref K211495

Inspire 8 Dual Hollow Fiber Oxygenator With With Integrated Hardshell Venous/Cardiotomy Ref K121229

Inspire 6 Hollow Fiber Oxygenator With Integrated Hardshell Venous/Cardiotomy Reservoir Ref K113626

Retrograde Cardioplegia Cannula, Self-Inflating, With Malleable Or Guidewire Stylet Ref K002019

Inspire 8 Hollow Fiber Oxygenator With Integrated Hardshell Venous/Cardiotomy Reservoir Ref K122254

Aortic Arch Cannulas Ref K943934

SH14 Hemoconcentrator Ref K081313

Bmr 1900 Phisio Ref K223361

D100 Kids; D101 Kids Ref K231652

FDA recalls6

Recalls initiated per year

FDA establishments1

Frequently asked questions