Integra LifeSciences and the U.S. Food and Drug Administration (FDA) are warning consumers about a recall of LimiTorr Volume Limiting Cerebrospinal Fluid (CSF) Drainage System and MoniTorr Intracranial Pressure (ICP) External CSF Drainage and Monitoring Systems. This FDA medical device recall is a Class I recall, meaning that using these...
Class I Recall of Defective Infant Warmers
The U.S. Food and Drug Administration (FDA) has issued a Class I recall of GE Healthcare's Giraffe and Panda i-Res infant warmers. A Class I recall is the most serious class given to defective medical devices. The recall instructs medical professionals in hospitals and other clinical settings to inspect the...
Hamilton Medical Issues a Medical Device Recall over Software Defect
Hamilton Medical, a device maker based in Switzerland, issued a medical device recall of 4,300 ventilators because of a software error that shuts off the life-sustaining machines. The specific devices associated with this device recall are Hamilton G5 ventilators. The ventilators included in the recall were manufactured between November 29,...
What Are Medical Device Recalls?
The U.S. Food and Administration (FDA) reports on, monitors, and enforces medical device recalls for public safety. But, what does that really mean? What exactly is a medical device recall and how do recalls affect consumers? Let’s take a look. Medical Device Recalls A recall means that the FDA and/or...
FDA Recalls Medtronic Insulin Pumps Due to Hacker Risk
The U.S. Food and Drug Administration (FDA) issued a warning to patients and the medical community about Medtronic MiniMed insulin pumps because some of the devices are vulnerable to hackers. FDA recalls for cybersecurity problems are rare even though the agency and other experts have expressed concerns about medical device...
Details of a Medical Device Recall Kept Secret by the FDA’s Secret Reporting Pathway
The details of a medical device recall involving an implantable defibrillator is alarming to say the least. The Sprint Fidelis, an internal defibrillator, is one of an unknown number of malfunctioning medical devices the U.S. Food and Drug Administration (FDA) kept hidden from the public via a confidential adverse event...
FDA Regulation of Medical Devices: How Safe are We?
The U.S. Food and Drug Administration (FDA) is a federal regulatory agency responsible for monitoring and reporting on food, pharmaceutical, and medical devices. A series of widespread injuries caused by FDA-approved drugs and medical devices - coupled with a damning scandal about their hidden database that distorts safety information -...
Urgent Device Recall: Chemotherapy Patients May be at Immediate Risk
ICU Medical, Inc. recently issued an urgent device recall for their hazardous closed drug delivery systems used in administering chemotherapy to cancer patients. Chemotherapy patients who receive treatment through a closed delivery system are in danger, and as such, the U.S. Food and Drug Administration (FDA) has classified this recall...
The FDA’s Hidden Database Protects Companies, Reduces Medical Device Recalls
In a bombshell report, Kaiser Health News is shining a light on a little-known practice of the U.S. Food and Drug Administration (FDA) that puts Americans at risk. The FDA’s “alternative summary” program is a private reporting procedure that allows manufacturers to potentially avoid medical device recalls. That is because...
Defibrillator Recall: Wearable Defibrillators Recalled after Injuries and Deaths Reported
Zoll Medical Corporation issued a recall of their wearable defibrillator LifeVest 4000 after the U.S. Food & Drug Administration (FDA) received reports of two deaths and an undisclosed number of miscellaneous injuries. This defibrillator recall is intended to prevent a potentially deadly malfunction. What is the LifeVest 4000? The Zoll...
FDA Issues a Recall of Test Strips Sold by Terrific Care/Medex
The U.S. Food & Drug Administration (FDA) reports that medical supply distributor Terrific Care/Medex Supply LLC has issued a voluntary device recall of certain test strips used to monitor patients who take the blood thinner warfarin. This FDA device recall has been classified as a Class I - the most...
Gore Medical: Hernia Mesh Manufacturer
Gore Medical Watch What should I watch out for? Gore Medical is a global company that makes many different medical products including grafts, medical devices and surgical meshes used by doctors. Gore Medical is a division of W.L. Gore and Associates, Inc., a worldwide manufacturing company specializing in polymer polytetrafluoroethylene...