2018, Year of Healthcare Product Recalls

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:

Company Product Recall Date Reason
GE Healthcare CareScape R860 Inspiratory Safety Guard October 2018 risk of the device disconnecting from the patient’s breathing circuit
Synaptive Medical BrightMatter Guide with SurfaceTrace Registration October 2018 software 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 Stimulator February 2018 to ensure the product is bacteria and chemical residue free
Oscor Inc. TB Temporary Bipolar Pacing Leads September 2018 to prevent patient inconvenience
Beckman Coulter Inc. FC500 Series Flow Cytometers and EPICS XL Series Flow Cytometers October 2018 resulted in inaccurate data due to an electrical circuit error
GE Healthcare Millennium Nuclear Medicine Systems September 2018 system malfunction
Maquet Datascope Corp./Getinge Group Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) September 2018 due to the potential malfunction of the autofill process during its use at altitudes above 3200 feet
Alcon Research ltd. CyPass Micro-Stent August 2018 inconvenience in post-surgery data from the COMPASS-XT safety study
Endologix Inc. AFX Endovascular AAA System (AFX) July 2018 due to continued reports of Type IIIa and IIIb endoleaks
BioMerieux SA VITEK 2 Gram Positive Cefoxitin Screen and VITEK 2 Gram Positive AST January 2018 due to false results for strains of methicillin resistant Staphylococcus aureus (MRSA)
Vyaire Medical Inc. AirLife Resuscitation Device May 2018 due to a manufacturing error enabling extra plastic material in the oxygen output connection to reduce oxygen flow for the patient
Qiagen Sciences LLC AmniSure ROM Test May 2018 potential manufacturing defect leading to misinterpretation of test results
Draeger Medical Systems Inc. Jaundice Meter JM-103 and Jaundice Meter JM-105 May 2018 due to misinterpretation of display messages for out of range values
Medtronic plc HeartWare Ventricular Assist Device (HVAD system) May 2018 due to unintended intermittent electrical disconnection between the power source and the controller
Abbott Laboratories HeartMate 3 Left Ventricular Assist System April 2018 due to a malfunction in the device’s outflow graft assembly causing the outflow graft to twist and close over time
Medtronic plc MindFrame Capture LP revascularization device February 2018 due to the risk of delivery wire damage during use
Drager Medical GmbH Fabius Anesthesia machines March 2018 due to excessive oil that was not removed at the time of production
Medtronic plc Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) January 2018 manufacturing 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 Systems March 2018 potential for non-tuberculous mycobacteria (NTM) to grow in the water tank of the heater-cooler units
Becton Dickinson & Co. Vacutainer EDTA Blood Collection Tubes March 2018 interfered with the accuracy of the Anodic Stripping Voltammetry (ASV) testing methodology

– Victor Mukherjee,
Assistant Manager,
Infoholic Research