All Articles Tagged With: "Medical Device"
Articles
Q-Syte Luer Access Device Recall Expanded: Air Leakage May Cause Death
Defective manufacturing that caused an infant to suffer an air embolism has resulted in the expansion of a Class 1 medical recall for millions of Q-Syte Luer Access devices, which are used to add drug therapies to intravenous systems.
Boston Scientific Defibrillator Recall: Unapproved Manufacturing Changes
Boston Scientific has been forced to recall several models of implantable heart defibrillators after failing to notify the FDA that it made changes to the devices’ designs.
DePuy ASR Metal Hip Replacement Linked to High Failure Rate
DePuy Orthopaedics, a division of Johnson & Johnson, has indicated that its ASR metal-on-metal hip replacement system, has been linked to a high failure rate and the device will be removed from the market.
Abiomed AB5000 Circulatory Support System Recall: Risk of Injury or Death
A Class 1 medical device recall has been issued for Abiomed, Inc.’s AB5000 Circulatory Support System after it was determined that the device, which keeps the heart pumping in cases of heart failure, can suddenly stop operating without warning.
Counterfeit Polypropylene Mesh Marketed as Bard Surgical Mesh: FDA
The FDA is warning that health care professionals may have been sold a counterfeit surgical mesh under the C.R. Bard brand name, which could put patients in danger.
Pain Pump Chondrolysis Lawsuit Centralization to be Reconsidered
Later this month, a panel of federal judges will hear additional arguments about whether to centralize more than 100 shoulder pain pump chondrolysis lawsuits filed in federal district courts throughout the United States by plaintiffs who allege that the use small pumps to infuse pain medication following arthroscopic surgery destroyed their shoulder cartilage.
Transseptal Sheath Introducer Kit Recall: Risk Tip May Break Off
A Class 1 medical device recall has been issued for Transseptal Sheath Introducer Kits by Thomas Medical Products, a subsidiary of General Electric’s healthcare division, because the sheath tips can break off during heart procedures, potentially causing permanent injury or death.
Metal-on-Metal Hip Implant Parts Linked to Reports of Problems
Health care professionals are warning of increasing signs of problems with metal-on-metal hip implants, which could affect up to 3 percent of all recipients.
FDA Meeting Today to Review Mounting Problems with Insulin Pumps
A panel of outside advisers to the FDA are scheduled to meet today to review what steps the regulatory agency might take to reduce the risk of potentially serious problems for diabetics caused by insulin pumps. The FDA has noted a disturbing number of problems with insulin pumps, which are growing in popularity. [...]
Baxter HomeChoice Dialysis Machine Recall Issued After Reported Death
The FDA has issued a Class 1 recall for several models of Baxter HomeChoice automated dialysis systems because of a defect that can cause the machines to overfill a patient’s abdominal cavity with fluid. Reports of at least one death and several serious injuries have been associated with the problems.
