Category: Medical Devices
FDA Warns Inaccurate Lab Tests Harming Patients
November 23, 2015 — The FDA has concluded that unreliable laboratory tests are harming patients and the agency has asked Congress for increased oversight, according to the New York Times. The FDA reviews tests used in multiple hospitals, labs, or...
FDA Warning: 9 Deaths Due to Coatings on Medical Devices
November 23, 2015 — The FDA has issued a Safety Communication warning that certain coatings on intravascular medical devices can separate and cause life-threatening side effects. Hydrophilic and/or hydrophobic coatings include silicone, polyvinylpyrrolidone (PVP), and polytetrafluoroethylene (PTFE). They decrease friction...
Study Finds IVC Filters May Not Help Trauma Patients
IVC Filters have been linked to serious risks and questionable benefits.
Doctor Warned About Morcellator Cancer Risk in 2006
The FDA and Johnson & Johnson say there were no reports of morcellators upstaging or disseminating cancer before December 2013, but a retired pathologist warned about the risk in 2006.
Bronchoscope Infection Lawsuit Filed in Washington
November 18, 2015 — The Seattle Times reports that a 60 year-old Navy Veteran has died from antibiotic-resistant pneumonia transmitted on a dirty bronchoscope. Chief Petty Officer William Piersawl of Lynnwood, Washington, a retired Navy veteran after 25 years of...
Custom Ultrasonics Recalls Endoscope Cleaning Devices
November 16, 2015 — The FDA has ordered Custom Ultrasonics to recall about 2,800 machines that clean endoscopes because they may not work, which could increase the risk of infections. The FDA said Custom Ultrasonics is in violation of a...
Zimmer Wins 1st Trial Over NexGen Knee Implant
November 9, 2015 — The first trial involving the NexGen knee replacement has ended in a win for Zimmer Inc., according to Law360. Plaintiff Kathy Batty was implanted with the NexGen Flex, a high-flexibility knee implant that was approved by...
Essure Lawsuit Claims Bayer Hid Side Effects
November 9, 2015 — A lawsuit has been filed against Bayer HealthCare by a woman who was seriously injured by the Essure sterilization implant. The lawsuit (PDF) was filed by plaintiff Danielle Patterson in the U.S. District Court for the...
Essure Fracture
Broken pieces of a fractured Essure implant may fail to prevent pregnancy or perforate internal organs. In many cases, they must be surgically removed. Overview Essure is a delicate medical device that consists of a plastic micro-insert surrounded by two...
Nevada Investigates Cryotherapy Safety After Death
A woman in Nevada died after losing consciousness inside a cryotherapy machine.