Baxter Issues Volara Recall; Respiratory Device May Cause Respiratory Distress
On June 1, 2022, Baxter International Inc. announced an Urgent Medical Device Correction for its Volara System (home care). This Volara recall was voluntary. Baxter inherited the Volara device when it acquired Hillrom for $12.5 billion. According to the U.S. Food and Drug Administration (FDA), Baxter voluntarily issued the Urgent … [Read more...] about Baxter Issues Volara Recall; Respiratory Device May Cause Respiratory Distress
FDA Teleflex Recall Brings Back Over 6 Million Endotracheal Devices
The U.S. Food and Drug Administration (FDA) has jurisdiction over a wide variety of medical devices and drugs. Endotracheal tubes (ETT) are some such medical devices that are used for opening a patient’s airway, providing ventilation, and administering anesthesia during an operation. One manufacturer of these ETTs, Teleflex has … [Read more...] about FDA Teleflex Recall Brings Back Over 6 Million Endotracheal Devices
Essure Lawsuits Continue to Be Filed
Bayer Faces Thousands of Essure Injury Lawsuits Product liability lawsuits continue to be filed against Bayer alleging injuries from Essure, the female sterilization device. In the United States, roughly 3,700 lawsuits have been filed. Litigation has also begun in Canada. The U.S. Food and Drug Administration (FDA) reports over … [Read more...] about Essure Lawsuits Continue to Be Filed
Transvaginal Lawsuit Update
Transvaginal Mesh Lawsuit Update: Ethicon Agrees to $120M Vaginal Mesh Settlement In January 2016, Johnson & Johnson agreed to pay over $120 million to settle 2,000 to 3,000 transvaginal mesh lawsuits alleging the pelvic mesh devices caused pain, organ damage and other injuries. A regulatory filing showed the company still … [Read more...] about Transvaginal Lawsuit Update
Deep Brain Stimulation Rechargers May Fail to Charge, Medtronic Warns
In an October 2016 “Urgent Field Safety Notice”, Medtronic warned that some rechargers for its deep brain stimulation devices may be prone to an “error state” and fail to charge. According to the letter, some of its Model 37751 rechargers may become unresponsive and fail to recharge the neurostimulator until they are reset. The … [Read more...] about Deep Brain Stimulation Rechargers May Fail to Charge, Medtronic Warns
Texas Woman Sues 3M over Defective Surgical Warming Device
A Texas woman has sued 3M, accusing the company of selling defective surgical equipment responsible for a drug-resistant infection that led to a leg amputation. This case is the latest in a series of cases that argue 3M’s patient-warming Bair Hugger device causes dangerous infections, Law360 reports. … [Read more...] about Texas Woman Sues 3M over Defective Surgical Warming Device
Medtronic Defective Medical Device Ruling
Medtronic Defective Medical Device. Lawmakers in Congress are getting closer to passing legislation that would overturn a Supreme Court decision that barred people injured by defective medical devices from suing in state courts if the device was approved by the Food & Drug Administration (FDA). Two members of the House of … [Read more...] about Medtronic Defective Medical Device Ruling
Faster Recall of Medical Devices Urged
Doctors at Johns Hopkins Hospital traced a bacterial outbreak to a defective medical device . Doctors at the Johns Hopkins Hospital who traced a bacterial outbreak to a defective medical device say the problem might have been averted by a faster and broader product recall. Writing this week in The New England Journal of Medicine, … [Read more...] about Faster Recall of Medical Devices Urged
