The U.S. Food and Drug Administration (FDA) has announced a recall of more than 106,000 Medtronic heart catheters. According to the FDA announcement, the device recall follows numerous complaints about the devices not performing as expected. The FDA classifies this recall as a Class I. Class I medical device recalls...
FDA Issues Multiple Safety Alerts for Medical Devices
The U.S. Food and Drug Administration (FDA) issues recalls and safety alerts to keep consumers and the healthcare community informed. Safety alerts often involve drugs, medical devices, supplements and cosmetics. In September, the FDA issued multiple new safety alerts for medical devices and drugs. Several of the safety alerts involve...
FDA Recalls Textured Breast Implants over Cancer Concerns
In July, 2019, the U.S. Food and Drug Administration (FDA) requested that Pharmaceutical manufacturer, Allergan, recall certain textured breast implants. FDA recalls like this one highlight ongoing concerns about breast implants and resulting illnesses. It also continues the discussion about whether a warning or a medical device recall is more...
Integra LifeSciences and FDA Medical Device Recall of CSF Systems
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...