2018 Medical Device Recalls You Should Know About

By Gilreath & Associates

Another year, another list of medical device recalls (unfortunately).

Sadly, the 2018 list of medical device recalls has around the same number of recalls in 2017.

You can review the list of medical device recalls for 2018 below.

Don’t hesitate to contact your doctor if you have any questions about a device that you see listed below. Then, contact a knowledgeable defective medical device lawyer at Gilreath & Associates.

PRODUCT NAME & RECALL DESCRIPTION	RECALL DATE
GE Healthcare recalls CareScape R860 Inspiratory Safety Guard due to risk of disconnection from breathing circuit	12/12/18
Synaptive Medical recalls BrightMatter Guide with SurfaceTrace Registration due to software defect	11/27/18
Zimmer Biomet, Inc. recalls Spinal Fusion and Long Bone Stimulators due to lack of adequate validation and controls to ensure product cleanliness	11/26/18
Oscor recalls TB Temporary Bipolar Pacing Leads due to connector separation causing potential for loss of pacing	11/23/18
Beckman Coulter Life Science recalls FC 500 and the EPICS XL Series Flow Cytometers due to risk of inaccurate results	11/20/18
GE Healthcare recalls Millennium Nuclear Medicine Systems due to risk of detector detaching and falling	11/15/18
Roche Diagnostics recalls CoaguChek XS PT Test Strips due to inaccurate INR test results	11/01/18
Maquet Datascope Corp/Getinge Group recalls the Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) due to possible malfunction and failure at high altitudes	11/01/18
Alcon Research, LTD recalls CypassⓇ Micro-Stent Systems due to risk of endothelial cell loss	10/24/18
Endologix, Inc. recalls AFX Endovascular AAA Systems due to risk of Type III Endoleaks	10/15/18
Pro-Med Instruments recalls the DORO LUCENT Headrest due to possible malfunction and failure	09/28/18
Ventana Medical Systems recalls multiple Detection Kits due to potential for false negative results caused by reagent dispenser issues	09/28/18
Vyaire Medical, Inc. recalls Tri-Flo Subglottic Suction System due to risk of device breakage	09/04/18
Compass Health Brands recalls CPAP Mask Cushion Devices due to possible air leaks	08/31/18
BioMerieux recalls VITEK 2 Gram Positive Antimicrobial Susceptibility Testing (AST) Cards due to false results for some strains of methicillin-resistant Staphylococcus aureus (MRSA)	08/23/18
Arkon Anesthesia Delivery System recalled due to unexpected failed state while in use or idle	08/10/18
Vyaire Medical, Inc. recalls AirLife Resuscitation Devices due to manufacturing error preventing oxygen delivery	08/10/18
Qiagen Sciences LLC. recalls the AmniSure ROM Test due to lack of control line which may lead to misinterpretation of test results	08/08/18
Draeger Medical Systems, Inc. Jaundice Meter JM-103 and Jaundice Meter JM-105 recalled due to misinterpretation of display messages for out of range values	06/22/18
Maquet Datascope Corp./Getinge Group recalls the CARDIOSAVE Hybrid Intra-aortic Balloon Pump due to fluid ingress that may affect device operation and interrupt or delay therapy	06/06/18
Medtronic HeartWare HVAD System recalled due to unintended intermittent electrical disconnection between the power source and the controller	06/01/18
Abbott recalls the HeartMate 3™ Left Ventricular Assist System due to potential malfunction that may lead to graft occlusion	05/22/18
Medtronic recalls MindFrame Capture LP Revascularization Device due to wire material that may break or separate during use	05/18/18
Vyaire Medical recalls AirLife Resuscitation Devices and Broselow Convenience Kits due to risk of malfunction caused by error in product design	05/11/18
Dräger Medical recalls Fabius Anesthesia Machines due to production step error	05/09/18
Terumo recalls Sarns™ TCM and TCM II Cooling and Heating Systems and HX2™ Temperature Management Systems due to revised cleaning instructions	05/07/18
Becton Dickinson (BD) and Company recalls Vacutainer® EDTA Blood Collection Tubes due to chemical interference with certain tests	03/23/18
Monteris Medical NeuroBlate System recalled due to unexpected heating of laser delivery probes	03/22/18
Medtronic recalls Cardiac Resynchronization Therapy and Implantable Cardioverter Defibrillators due to manufacturing error preventing electrical shock delivery	02/26/18
Vyaire Medical recalls AirLife Humidification Chamber & Heated Breathing Circuit Kits due to manufacturing error	01/30/18
Edwards Lifesciences LLC. recalls Certitude Delivery System due to mold overflow defect which may obstruct blood flow	01/11/18
Sterilmed Reprocessed Agilis Steerable Introducer Sheath recalled due to improper seal of the sheath hub	01/02/18

Source: https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm535289.htm

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