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  1. Medical Device Recalls

The list below contains recalls that were issued in 2019.

2019 Medical Device Recalls

Device Name Date
Zimmer Biomet Recalls ROSA Brain 3.0 Robotic Surgery System Due to Software Issue that Incorrectly Positions the Robotic Arm 11/07/19
Medtronic Recalls Remote Controllers for MiniMed Insulin Pumps for Potential Cybersecurity Risks 11/05/19
Philips Medical Systems (Cleveland) Recalls Forte Gamma Camera System Due to Potential for the Detector to Drop 11/04/19
Abbot Recalls CentriMag Circulatory Support System Motor Due to Pump and Motor Issues 11/04/19
Ethicon Recalls ECHELON FLEX™ ENDOPATH® Staplers for Failure to Completely Form Staples 10/30/19
Medtronic Recalls 6 French Sherpa NX Active Guide Catheters Due to Separation and Fragmentation Issue 10/08/19
Allergan Recalls Natrelle Biocell Textured Breast Implants Due to Risk of BIA-ALCL Cancer 09/12/19
Edwards Lifesciences, LLC, Recalls SAPIEN 3 Ultra Delivery System Due to Burst Balloons During Surgery, Which May Result in Vascular Injury, Bleeding, or Surgical Intervention 08/22/19
Medline Industries, Inc., Recalls Centurion Medical Products' Primary Warmer Pack and Primary Set Pack Containing Becton Dickinson Alaris Pump Model 8100 Infusion Sets Due to Potential for Tube Collapse that May Cause Unintended Delivery or Faster than Expected Delivery of Medication 08/21/19
Medline Industries, Inc., Recalls Centurion Medical Products' Primary Warmer Pack Containing Vyaire Medical enFlow Fluid Warming Disposable Cartridge Due to Potential Risk of Exposure to Elevated Levels of Aluminum 08/21/19
Fresenius Kabi Recalls Volumat MC Agilia Infusion Pump and Vigilant Agilia Drug Library Due to a "Low Priority" "Keep Vein Open (KVO), End of Infusion" Alarm and Multiple Software Errors 08/12/19
Abbott (Formerly St. Jude Medical Inc.), Recalls Ellipse Implantable Cardioverter Defibrillators Due to Exposed Aluminum Wires That May Prevent Defibrillation Therapy 08/05/19
QIAGEN Recalls Filter Tips for use with the QIAsymphony SP/AS Instruments Due to Potential to Leak, Which May Result in Delayed or Inaccurate Results 08/02/19
Centurion Medical Products Recalls Airway Kit containing Sheridan® Endotracheal Tubes Due to Potential for the Tube Connector to Dislodge, Which May Result in Disconnection of the Patient from the Breathing Circuit 08/02/19
Datascope/Getinge Recalls Cardiosave Hybrid, Cardiosave Rescue, CS300 and CS100/100i Intra-Aortic Balloon Pumps (IABP) Due to Potential Battery Failure 07/23/19
Becton Dickinson (BD) Recalls Alaris Infusion Sets for the Alaris Pump Model 8100 Due to Potential for Tube Collapse that May Cause Unintended Delivery or Faster than Expected Delivery of Medication 07/18/19
Becton Dickinson (BD) (CareFusion 303, Inc.) Recalls Alaris Pump Module Model 8100 Bezel Assembly Which Could Result in Free Flow, Over-Infusion, Under-Infusion, or Interruption of Infusion 07/18/19
Teleflex Recalls NEONATAL ConchaSmart Breathing Circuit Due to Circuit Cracks 07/17/19
GE Healthcare, LLC Recalls Giraffe Infant Warmers and Panda i-Res Infant Warmers Due to Bedside Panels and Latch Areas Cracking or Breaking 07/12/19
Hamilton Medical AG Recalls Hamilton-G5 Ventilators Due to Potential for Sporadic Error Message Resulting in the Ventilator to Cease Ventilation and Enter Ambient State 07/12/19
Becton Dickinson & Company (BD) Recalls SmartSite Syringe Administration Set Due to Risk of Leaks 07/01/19
Edwards Lifesciences Recalls the IntraClude Intra-Aortic Occlusion Device Due to Risk of Balloon Rupture 07/01/19
Vyaire Medical Recalls the enFlow Fluid Warming System Disposable Cartridges Due to Potential Risk of Exposure to Elevated Levels of Aluminum Exposure to Patients 06/27/19
Teleflex Medical Recalls the Hudson RCI Sheridan and Sheridan Endotracheal Tubes Due to Risk of the Sheridan Connector Disconnecting from the Breathing Circuit 06/21/19
Cook Incorporated Recalls Advance Enforcer 35 Focal Force PTA Balloon Catheter Due to Balloons Bursting Below the Rated Burst Pressure 06/18/19
Terumo Medical Corporation Recalls SOLOPATH® Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System Due to Dislodgement of the Fairing Tip from the Sheath 05/30/19
lntegra LifeSciences Recalls the LimiTorr Volume Limiting CSF Drainage System and the MoniTorr ICP External CSF Drainage and Monitoring System Due to Possible Breakage of the LimiTorr Transducer and MoniTorr Panel Mount Stopcock 05/24/19
Edwards Lifesciences LLC Recalls EV1000 Clinical Platforms Due to Electrical Short Circuit Which May Cause the Device to Stop Working or Catch Fire 05/24/19
Beckman Coulter Life Sciences Recalls DxH800 and DxH600 and DxH 900 Hematology Analyzers Due to Risk of Inaccurate Results 05/23/19
Ethicon Recalls Circular Staplers for Insufficient Firing and Failure to Completely Form Staples 05/16/19
Alpha Omega Engineering Recalls Neuro Omega System Due to Design Flaw Which May Cause Significant Tissue Harm 05/06/19
Edwards Lifesciences Recalls Miller and Fogarty Atrioseptostomy Dilation Catheters Due to Balloon Deflation, Fragmentation and Detachment Issue 04/26/19
Brainlab AG Recalls Spine & Trauma 3D Navigation Due to Inaccurate Display That May Result in User Misinterpretation 04/15/19
O-Two Medical Technologies, Inc. Recalls o_two e700, e600 and e500 Automatic Transport Ventilators Due to Potential Risk of Fire 04/03/19
Cook Medical Inc. Recalls Transseptal Needle Due to Risk of Detached Plastic Fragments 03/18/19
RVO 2.0, Inc. Recalls Raindrop Near Vision Inlay Due to Risk of Increased Risk of Corneal Haze 03/05/19
Physio-Control Recalls LIFEPAK15 Monitor/Defibrillator Due to Risk of Device "Lockup" (Freezing) 02/27/19
Medtronic, Inc. Recalls Dual Chamber Implantable Pulse Generators (IPGs) Due to Possible Circuit Error 02/22/19
Edwards Lifesciences Recalls Swan-Ganz Thermodilution Catheter Due to Incorrect Assembly Causing Reversal of Lumens 02/15/19
Medex Cardio-Pulmonary, doing business as Smiths Medical, Recalls Sterile Saline and Sterile Water for Inhalation Due to Potential Exposure to Infectious Agents as a Result of Leaking Containers 02/05/19
Terrific Care, LLC. / Medex Supply Recalls CoaguChek XS PT Test Strips Used to Monitor Blood Thinner Warfarin Due to Inaccurate Test Results 02/04/19
West Pharmaceutical Services Inc. Recalls Vial2Bag Fluid Transfer Systems Due to Potential Malfunctions 02/01/19
Draeger Medical Recalls Breathing Circuits and Anesthesia Sets 01/25/19
Medtronic Recalls Synergy Cranial Software and Stealth Station S7 Cranial Software Due to Inaccuracies Displayed During Surgical Procedures 01/08/19

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