FDA Device Recalls

Recalls / Firms / Sorin Group USA, Inc.

Sorin Group USA, Inc.

135 FDA device recalls on record.

DateClassProductReason
2017-09-28FlexFlow Venous Cannula Model/Catalog Number 200-200 The FlexFlow Venous Cannula is a single use ste
2017-06-30STOCKERT Heater-Cooler System 3T, 240V/60 Hz
2017-06-30STOCKERT Heater-Cooler System 3T, 208V/60 Hz
2017-06-30STOCKERT Heater-Cooler System 3T, 230 V
2017-06-30STOCKERT Heater-Cooler System 3T, 127V/60 Hz
2017-06-30STOCKERT Heater-Cooler System 3T, 200V/50 Hz/60 Hz
2017-06-30STOCKERT Heater-Cooler System 3T, 120V/60 Hz
2017-06-29NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
2017-06-29SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA
2017-06-29SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA
2017-06-29SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA
2017-06-29STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO,
2017-06-29SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA
2017-06-29SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only
2017-06-29SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA
2017-06-29SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
2017-06-29SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA
2017-06-29SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA
2017-06-29NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLI
2017-06-29NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR
2017-06-29SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA
2017-06-29SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b)
2017-06-29SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA
2017-06-09Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic
2016-10-31Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic
2016-09-29The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program an
2016-09-29The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and int
2016-08-25Stckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product
2016-08-12Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aor
2016-08-12Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion
2016-06-22AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA
2016-01-25Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LR
2016-01-19CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart P
2015-06-15Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfus
2015-06-15Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of
2015-06-15Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of
2015-06-15Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal perfusion of
2015-06-15Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of
2015-06-15Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of duration
2014-08-01STCKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282,
2013-07-08Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
2013-01-28Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are i
2012-09-20SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S0913
2012-09-20SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S0914
2012-09-19S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be us
2012-09-19S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be u
2012-09-19S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be
2012-09-19S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be use
2012-09-19Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be u
2012-09-14Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot Numbers: 1
2012-09-14Gish 3/8 x 1/2" Reducer Connector with Luer fitting, Item Numbers: EC2180S, Lot Numbers: 1108900099,
2012-08-15Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H
2012-02-16Stockert, S5 Double roller pump 85, Part 10-85-00, Sorin Group Deutschland GMBH, Lindberghstrasse 25
2012-02-16SORIN C5 CONSOLE Part No.: 58-00-00, SORIN GROUP DEUTSCHLAND GMBH Lindberghstrasse 25, 80939 Munchen
2012-02-16SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SRD S5 MAST ROLLER PUMP,
2012-02-16Stockert S5 Control and display module, Part No.: 28-95-10, Sorin Group Deutschland GMBH, Lindberghs
2012-02-16S5/C5 Control panel for 2 mast roller pumps 85, Part No.: 28-95-85, Sorin Group Deutschland GMBH, Li
2012-02-16S5/C5 control panel for mast roller pump 150/85, Part No.: 28-95-80, Sorin Group Deutschland GMBH, L
2012-02-16SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, S5 TWO MAST PUMPS 85 W/ C
2012-02-16SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SRD S5 TWO MAST ROLLER PU
2012-02-16Stockert, S5 Roller pump 150, Part 10-80-00, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 8093
2012-02-16SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SDR S5 MAST ROLLER PUMP 8
2011-12-02Apex Oxygenator, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada
2011-12-02Apex HP Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc
2011-12-02PTS Heart/Lung Perfusion Pack Labeling Sterile EO, Product is manufactured by Sorin Group USA, Inc,
2011-12-02Apex HP PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group U
2011-12-02D 905 EOS Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, I
2011-12-02Synthesis PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group
2011-12-02Apex HP PHisio SMART Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin G
2011-12-02D 903 Avant Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA,
2011-12-02SYNERGY Perfusion Tubing Systems US Denver PHISIO, Sorin Group USA, Tubing set heart-lung bypass, St
2011-12-02Apex SMART PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Grou
2011-12-02PRIMO2X Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc
2011-12-02Apex Phisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA,
2010-11-12S5 Display and Control Module, Part No.: 28-95-10, Sorin Group Deutschland Gmbh, Lindberghstrasse 25
2010-11-12S5 Control Panel for 2 Mast Roller Pumps 85, Part No.: 28-95-85, Sorin Group Deutschland Gmbh, Lindb
2010-11-12SRD S5 Mast Roller Pump System 85, S5 Component, Part No.: 50-80-70, Made in Germany, Distributed by
2010-11-12SRD S5 Mast Roller Pump System 150, S5 Component, Part No.: 50-80-00, Made in Germany, Distributed b
2010-11-12S5 Mast Roller Pump System 85, Part No.: 28-95-80, Sorin Group Deutschland Gmbh, Lindberghstrasse 25
2010-11-12SRD S5 Mast Roller Pump System, S5 Component, Part No.: 50-80-60, Made in Germany, Distributed by: S
2010-11-12Stockert, S5 Double Roller Pump 85, Part No.: 10-85-00, Sorin Group Deutschland Gmbh, Lindberghstras
2010-11-12S5 C5-System, Part No.: 58-00-00, Sorin Group Deutschland Gmbh, Lindberghstrasse, 25, Munchen, Germa
2010-11-122 S5 Mast Roller Pumps 85 with Double Holder, S5 Component, Part No.: 50-80-62, Made in Germany, Dis
2010-11-12Stockert, S5 Roller Pump 150, Part No.: 10-80-00, Sorin Group Deutschland Gmbh, Lindberghstrasse 25,
2010-10-07Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500600, Manufactured by Sorin Group USA, In
2010-10-07Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084503500, Manufactured by Sorin Group USA, In
2010-10-07Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084502100, Manufactured by Sorin Group USA, In
2010-10-07Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500900, Manufactured by Sorin Group USA, In
2010-10-07Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084501001, Manufactured by Sorin Group USA, In
2010-10-07Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500700, Manufactured by Sorin Group USA, In
2010-10-07Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504800, Manufactured by Sorin Group USA, In
2010-10-07Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084502000, Manufactured by Sorin Group USA, In
2010-10-07Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500300, Manufactured by Sorin Group USA, In
2010-10-07Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084503400, Manufactured by Sorin Group USA, In
2010-10-07Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500501, Manufactured by Sorin Group USA, In
2010-10-07Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504300, Manufactured by Sorin Group USA, In
2010-10-07Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500800, Manufactured by Sorin Group USA, In
2010-10-07Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500400, Manufactured by Sorin Group USA, In
2010-10-07Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084501200, Manufactured by Sorin Group USA, In
2010-10-07Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500500, Manufactured by Sorin Group USA, In
2010-10-07Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500200, Manufactured by Sorin Group USA, In
2010-10-07Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084503000, Manufactured by Sorin Group USA, In
2010-10-07Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500201, Manufactured by Sorin Group USA, In
2010-10-07Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500600, Manufactured by Sorin Group USA, In
2010-10-07Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084500500, Manufactured by Sorin Group USA, In
2010-10-07Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 084504500, Manufactured by Sorin Group USA, In
2010-06-18Mast Roller Pump, Catalog 50-80-00, for use with Sorin HLM C5 and HLM S5.
2010-06-18Electrical Venous Occluder, Catalog 12-80-00, for use with Sorin HLM C5 and HLM S5.
2010-06-18B-Care 5, Catalog 25-60-00, for use with Sorin HLM C5 and HLM S5.
2009-12-30Smart Perfusion Pack, REF: 088504500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada,
2009-12-30Smart Perfusion Pack, REF: 088503000, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada,
2009-12-30Smart Perfusion Pack, REF: 086500300, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada,
2009-12-30Smart Perfusion Pack, REF: 088500900, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada,
2009-12-30Smart Perfusion Pack, REF: 088503400, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada,
2009-12-30Smart Perfusion Pack, REF: 088501900, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada,
2009-12-30Perfusion Pack, REF: 088502800, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 800
2009-12-30Smart Perfusion Pack, REF: 088502200, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada,
2009-12-30Opti-Pack Smart Perfusion Pack, REF: 086500100, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way
2009-12-30Smart Perfusion Pack, REF: 088502500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada,
2009-12-30, REF: 084500500, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 Indicated
2009-12-30Smart Perfusion Pack, REF: 086500301, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada,
2009-12-30Smart Perfusion Pack, REF: 084500300, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada,
2009-12-30Smart Perfusion Pack, REF: 088500700, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada,
2009-12-30Smart Perfusion Pack, REF: 086500600, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada,
2009-12-30Smart Perfusion Pack, REF: 088501100, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada,
2009-11-25Sorin / Clearglide Precision Bipolar, REF PBD01, Sterile R, Manufactured for: Sorin Group USA, Inc.,
2009-11-25Sorin / Clearglide EVH Long View with Scissor, REF KTV23, Sterile R, Manufactured for: Sorin Group U
2009-11-25Sorin / Clearglide EVH Low Profile, REF KTV16, Sterile R, Manufactured for: Sorin Group USA, Inc., 1
2009-11-25Sorin / Clearglide EVH Long View, REF KTV22, Sterile R, Manufactured for: Sorin Group USA, Inc., 144
2009-11-25Sorin / Clearglide EVH Small, REF KTV15, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W
2009-11-25Sorin / Clearglide EVH Low Profile with Scissor, REF KTV18, Sterile R, Manufactured for: Sorin Group
2009-11-25Sorin / Clearglide EVH Small with Scissor, REF KTV17, Sterile R, Manufactured for: Sorin Group USA,
2009-09-25Revolution Blood Pump, "revOlution Centrifugal pump Catalog# 050300000***Rx ONLY***SORIN GROUP ITALI
2009-09-25Revolution Blood Pump with PC Coating, "revOlution Centrifugal pump Catalog# 050300700***Rx ONLY***S
2008-08-08Dideco, D901 Lilliput 1, Close Phisio, Sterile EO, REF 05252, Manufacturer: Sorin Group Italia, Via