Defective Medical Device News Roundup – December 2016
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Manufacturers recall medications and medical devices for a variety of reasons, from minor issues to major public safety hazards. As 2016 draws to a close, we want to highlight some of the medical recalls that manufacturers and government oversight agencies issued this past year.
HeartWare Ventricular Assist. HeartWare, Inc. issued a recall on these cardiac support devices on June 8. The Food and Drug Administration classified this recall as Class 1, the most serious type of recall. The devices can malfunction in ways that cause low speaker volume, electrical issues, and corrosion, leading to a host of serious health consequences, including death.
TeleFlex Tracheostomy Tube Set. TeleFlex recalled this device because the tubes in the ventilator can disconnect, which can deprive the patient of oxygen and lead to brain damage or death. This recall is also a Class 1 recall.
VentStar Oxylog 3000. The manufacturer recalled this breathing device after discovering that the check valve may leak, causing increased carbon dioxide levels that can lead to death. The FDA classified this recall as Class 1.
Medtronic Respiratory and Monitoring Solutions. The battery packs on these devices can malfunction due to a manufacturing defect. The issue can cause the battery to overheat and catch fire, causing serious injuries or death. The FDA classified this recall as Class 1.
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