The Recall Desk

Manufacturer

Sorin Group USA, Inc.

52 recalls in our database name Sorin Group USA, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
52
Critical
0
Severe
12
Most recent
2017-11-15

Of the 52 recalls from Sorin Group USA, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 12 (23%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–50 of 52

  • ModerateFDA (Devices)·Z-0682-2017·2016-12-07

    Sorin Group Recalls Stöckert Heater Cooler System 3T for Disinfection Review

    Sorin Group USA is recalling Stöckert Heater Cooler System 3T units to ensure strict adherence to disinfection and monitoring instructions.

    Product
    ST¿CKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 160285, HeaterCooler 3T, 120V/ 60Hz The Heater Cooler 3T is used with a St¿ckert S3 heart lung machine and / or any other heart
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0412-2017·2016-11-23

    Sorin Orchestra Programmer Recalled for Inaccurate Longevity Estimates

    Sorin Group USA is voluntarily recalling 847 Orchestra and Orchestra Plus programmers because residual longevity estimates may be inaccurate.

    Product
    The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitoring im
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0413-2017·2016-11-23

    Sorin Orchestra Plus Programmer Recalled for Inaccurate Longevity Estimates

    Sorin Group USA is recalling 586 Orchestra Plus programmers because their residual longevity estimates may be inaccurate, potentially affecting patient monitoring.

    Product
    The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report printing functions that are essential for monitori
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2866-2016·2016-09-28

    Sorin S5 Heart-Lung Machine Recalled for Power Supply Failure Risk

    Sorin Group USA is recalling 5,264 Stöckert S5 Heart-Lung Machines worldwide due to a potential failure of the Uninterruptible Power Supply.

    Product
    St¿ckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The St¿ckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. These devices come in direct contact with the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2756-2016·2016-09-14

    Sorin Aortic Arch Cannula Recalled for Improper Tip Angle

    Sorin Group USA is recalling Aortic Arch Cannulas because the tip angle is less than the required 45 or 90 degrees.

    Product
    Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flex
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2757-2016·2016-09-14

    Sorin Coronary Artery Perfusion Cannula Recalled for Tip Angle Defect

    Sorin Group USA is recalling 1,205 units of Coronary Artery Perfusion Cannulas with Balloons because the tip angle is less than the required 45 or 90 degrees.

    Product
    Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-2147-2016·2016-07-20

    Sorin Recalls Aortic Arch Cannulae Due to Incorrect Tip Angle

    Sorin Group USA is recalling Aortic Arch Cannulae because the distal tip angle is 15-20 degrees instead of the specified 45 degrees.

    Product
    AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of n
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1186-2016·2016-03-23

    Sorin Recalls Stockert Heater-Cooler 3T Units for Instruction Manual Updates

    Sorin Group USA is recalling 1,125 Stockert Heater-Cooler 3T units to update instruction manuals with water quality enhancements.

    Product
    Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz ; 16-02-82, H3T208V/60Hz ; 16-02-85, H3T/120V/60Hz. Device Listing E572259
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1018-2016·2016-03-02

    Sorin Group Recalls CDI H/S Cuvettes Due to Connection Error

    Sorin Group USA is recalling CDI H/S Cuvettes because they may fail to connect properly with the probe, causing the monitor to display an error and preventing blood parameter values from displaying.

    Product
    CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surger
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0813-2016·2016-02-24

    Sorin Dual Stage Venous Return Catheter Recalled for Incorrect Instructions

    Sorin Group USA is recalling 60 units of Dual Stage Venous Return Catheters because the cases contained incorrect Instructions For Use (IFU).

    Product
    Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Cardiopulmonary bypass catheter.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2076-2015·2015-07-22

    Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization

    Sorin Group USA, Inc. is recalling 2,837 Sorin Stockert Heater-Cooler 3T units due to potential colonization of organisms, including Mycobacteria, if proper disinfection and maintenance are not performed.

    Product
    Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2078-2015·2015-07-22

    Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization

    Sorin Group USA is recalling 283 Sorin Stockert Heater-Cooler 3T units due to potential colonization of organisms, including Mycobacteria, if proper disinfection is not performed.

    Product
    Sorin Stockert Heater-Cooler 3T, 208 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2079-2015·2015-07-22

    Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization

    Sorin Group USA is recalling 28 Sorin Stockert Heater-Cooler 3T devices due to potential colonization of organisms, including Mycobacteria, if proper disinfection and maintenance are not performed.

    Product
    Sorin Stockert Heater-Cooler 3T, 127 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2081-2015·2015-07-22

    Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization

    Sorin Group USA is recalling 131 Stockert Heater-Cooler 3T units due to potential colonization of organisms, including Mycobacteria, if proper disinfection and maintenance are not performed.

    Product
    Sorin Stockert Heater-Cooler 3T, 200 V / 50Hz / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2077-2015·2015-07-22

    Sorin Stockert Heater-Cooler 3T Recalled for Potential Organism Colonization

    Sorin Group USA is recalling 21 Sorin Stockert Heater-Cooler 3T units due to the potential for organism colonization, including Mycobacteria, if proper disinfection and maintenance are not performed.

    Product
    Sorin Stockert Heater-Cooler 3T, 240 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2080-2015·2015-07-22

    Sorin Heater-Cooler Devices Recalled for Potential Microbial Colonization

    Sorin Group USA is recalling Stockert Heater-Cooler 3T devices due to the potential for microbial colonization, including Mycobacteria, if proper disinfection and maintenance are not performed.

    Product
    Sorin Stockert Heater-Cooler 3T, 120 V / 60 Hz Temperature control for extracorporeal perfusion of durations up to 6 hours.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1985-2013·2013-08-28

    Sorin Group Recalls Edwards Lifesciences Suction Wands Due to Plastic Particles

    Sorin Group is recalling Edwards Lifesciences Suction Wand Model S099B because plastic particles were found inside the packaging pouch.

    Product
    Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0928-2013·2013-03-20

    Sorin Isoline Implantable Defibrillation Leads Recalled for Insulation Breach

    Sorin Group USA is recalling 1,376 Isoline implantable defibrillation leads due to potential internal insulation breaches. The leads are used for treating life-threatening heart arrhythmias.

    Product
    Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0271-2013·2012-11-14

    Sorin S5 Perfusion System Recalled for Motor Controller Faults

    Sorin Group USA is recalling S5 Perfusion Systems due to motor controller faults that may cause unintended pump stoppage during surgery.

    Product
    S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0274-2013·2012-11-14

    Sorin S5 Perfusion System Recalled for Motor Controller Faults

    Sorin Group USA is recalling S5 Perfusion Systems due to a motor controller fault that could cause unintended pump stoppage during surgery.

    Product
    S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0275-2013·2012-11-14

    Sorin C5 Perfusion System Recalled for Motor Controller Fault

    Sorin Group USA recalled two Sorin C5 Perfusion Systems due to a motor controller fault that could cause pump stoppage during surgery.

    Product
    Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0273-2013·2012-11-14

    Sorin S5 Perfusion System Recalled for Motor Controller Fault

    Sorin Group USA is recalling S5 Perfusion Systems due to a motor controller fault that may cause unintended pump stoppage during surgery.

    Product
    S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0272-2013·2012-11-14

    Sorin S5 Perfusion System Recalled for Motor Controller Fault

    Sorin Group USA is recalling S5 Perfusion Systems due to a motor controller fault that may cause unintended pump stoppage during surgery.

    Product
    S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0166-2013·2012-11-07

    Sorin SCP Pump Control Panel Recalled for Display Malfunction

    Sorin Group USA is recalling 12 SCP Pump Control Panels due to a circuit board defect that may cause display malfunctions and incorrect flow or pressure readings.

    Product
    SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0167-2013·2012-11-07

    Sorin SCP Pump Control Panel Recalled for Circuit Board Malfunction

    Sorin Group USA is recalling SCP Pump Control Panels due to a circuit board defect that may cause display malfunctions and incorrect flow or pressure readings.

    Product
    SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping thro
    Category
    Medical Device
    Distribution
    Distributed nationwide