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Market Updates

2018, Year of Healthcare Product Recalls

February, 2019

2018 had been the year of significant product recalls by major healthcare manufacturers. Starting from healthcare giants such as GE Healthcare, Medtronic, and Abbott Laboratories, the industry faced debacles in the continuation of branded medical devices by the consumers. Medtronic itself witnessed at least three different product recalls in 2018, impacting its Cardiovascular business globally. On the other hand, GE Healthcare confronted at least two product recalls in the last year.

Provided are the most significant product recalls of 2018:

CompanyProductRecall DateReason
GE HealthcareCareScape R860 Inspiratory Safety GuardOctober 2018risk of the device disconnecting from the patient’s breathing circuit
Synaptive MedicalBrightMatter Guide with SurfaceTrace RegistrationOctober 2018software defect found potentially dangerous for patient
Zimmer Biomet Inc.Osteogen Implantable Bone Growth Stimulator, SpF PLUS-Mini Implantable Fusion Stimulator, and the SpF-XL Implantable Spinal Fusion StimulatorFebruary 2018to ensure the product is bacteria and chemical residue free
Oscor Inc.TB Temporary Bipolar Pacing LeadsSeptember 2018to prevent patient inconvenience
Beckman Coulter Inc.FC500 Series Flow Cytometers and EPICS XL Series Flow CytometersOctober 2018resulted in inaccurate data due to an electrical circuit error
GE HealthcareMillennium Nuclear Medicine SystemsSeptember 2018system malfunction
Maquet Datascope Corp./Getinge GroupCardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs)September 2018due to the potential malfunction of the autofill process during its use at altitudes above 3200 feet
Alcon Research ltd.CyPass Micro-StentAugust 2018inconvenience in post-surgery data from the COMPASS-XT safety study
Endologix Inc.AFX Endovascular AAA System (AFX)July 2018due to continued reports of Type IIIa and IIIb endoleaks
BioMerieux SAVITEK 2 Gram Positive Cefoxitin Screen and VITEK 2 Gram Positive ASTJanuary 2018due to false results for strains of methicillin resistant Staphylococcus aureus (MRSA)
Vyaire Medical Inc.AirLife Resuscitation DeviceMay 2018due to a manufacturing error enabling extra plastic material in the oxygen output connection to reduce oxygen flow for the patient
Qiagen Sciences LLCAmniSure ROM TestMay 2018potential manufacturing defect leading to misinterpretation of test results
Draeger Medical Systems Inc.Jaundice Meter JM-103 and Jaundice Meter JM-105May 2018due to misinterpretation of display messages for out of range values
Medtronic plcHeartWare Ventricular Assist Device (HVAD system)May 2018due to unintended intermittent electrical disconnection between the power source and the controller
Abbott LaboratoriesHeartMate 3 Left Ventricular Assist SystemApril 2018due to a malfunction in the device's outflow graft assembly causing the outflow graft to twist and close over time
Medtronic plcMindFrame Capture LP revascularization deviceFebruary 2018due to the risk of delivery wire damage during use
Drager Medical GmbHFabius Anesthesia machinesMarch 2018due to excessive oil that was not removed at the time of production
Medtronic plcImplantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds)January 2018manufacturing defect preventing the device from delivering the electrical shock needed to pace a patient’s heartbeat
Terumo Corp.Sarns TCM and TCM II Cooling and Heating Systems; HX2 Temperature Management SystemsMarch 2018potential for non-tuberculous mycobacteria (NTM) to grow in the water tank of the heater-cooler units
Becton Dickinson & Co.Vacutainer EDTA Blood Collection TubesMarch 2018interfered with the accuracy of the Anodic Stripping Voltammetry (ASV) testing methodology

– Victor Mukherjee,
Assistant Manager,
Infoholic Research