Medical Devices
A High-Risk Medical Device Didn’t Meet Federal Standards. The Government Paid Millions for More.
Article Summary: Federal inspectors found serious problems with the HeartWare heart pump, but agencies like the Department of Veterans Affairs and Centers for Medicare & Medicaid Services continued paying to implant it in patients. By… Read More
FDA Warns Against Using Unapproved Ozone or Ultraviolet Light Products To Clean CPAP Machines
By Russell Maas, Aboutlawsuits.com, March 2, 2021. Federal health officials are warning against the use of ozone gas or ultraviolet (UV) light to clean continuous positive airway pressure (CPAP) devices or accessories, indicating these cleaning… Read More
Device Makers Have Funneled Billions to Orthopedic Surgeons Who Use Their Products
Article Summary: Medical device companies have offered illegal compensation to orthopedic and spine surgeons corrupting their medical judgment to perform unnecessary and wasteful surgeries causing serious patient harm. By Fred Schulte and Elizabeth Lucas, KHN,… Read More
5 Recent Drug, Device Recalls
Article Summary: This article compiles a list of recent drug and medical device recalls reported to the FDA. By Maia Anderson, Becker’s Hospital Review, Jun 21, 2021. Medical device and drug recalls, whether voluntary or… Read More
Abbott Recalls Assurity™ and Endurity™ Pacemakers
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Scalable Bradycardia Platform (SBP) Pacemakers: Assurity™ and… Read More
‘Painless’ Glucose Monitors Pushed Despite Little Evidence They Help Most Diabetes Patients
Article Summary: There’s little evidence continuous glucose monitoring (CGM) leads to better outcomes for most people with diabetes, yet they are being aggressively promoted to patients. By Phil Galewitz, KHN, Mar 16, 2021. In the… Read More
6 Recent Medical Device Recalls
Article Summary: This article compiles medical device recalls reported to the FDA since mid-April, 2021. By Maia Anderson, Becker’s Hospital Review, Apr 30, 2021. Medical device recalls, whether voluntary or mandated by the FDA, ensure… Read More
SURGICAL STAPLER LAWSUITS
By Jane Mundy, forlawyersandsettlements.com. Surgical stapler lawsuits aimed at medical device manufacturers claim that these defective surgical staplers have caused serious injuries—for many years: The majority of complications were concealed from the public by the… Read More
Reports Of Patients’ Deaths Linked To Heart Devices Hidden by the FDA
By Christina Jewett, KHN, Dec. 24, 2019. The Food and Drug Administration continues to file thousands of reports of patients’ deaths related to medical devices through a reporting system that keeps the safety data out… Read More