Regulatory/Legal
Dec 02, 2016
Baxter Device: All unexpired lots of the 50 mm 0.2 Micron Filter with product code H93835 Recall reason: According to information on the FDA...
Dec 02, 2016
Alere Device: Alere planned to take the INRatio and INRatio2 PT/INR Monitoring System, including INRatio Test Strips, off the market and to stop...
Dec 02, 2016
Hummingbird Med Devices Device: ABG-HM-1 Hummi Micro-Draw Blood Transfer Device under lot numbers 15180, 15286, 15287, 15300, 15305 Recall reason:...
Dec 02, 2016
HeartWare Device: Batteries used for the HeartWare Ventricular Assist Device (HVAD) with serial numbers BAT000001 to BAT 199999, model number 1650....
Dec 02, 2016
Boston Scientific Device: Certain lots of the Fetch 2 Aspiration Catheter, model number 109400-001. Click here for affected lot numbers. Recall...
Dec 02, 2016
Arrow International Device: Specific models of Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits Recall reason: According to information...
Dec 02, 2016
Cook Medical Device: Cook Medical's Single Lumen Central Venous Catheter Sets and Trays; Single Lumen Pressure Monitoring Sets and Trays; Femoral Artery...
Dec 02, 2016
2016 was a big year for medical device recalls, with the number of units recalled in the third quarter reaching the highest level in four years. Here are the...
Nov 21, 2016
FDA's final guidance on Medical Device Reporting for Manufacturers eliminates the need to report use errors that don't result in death or serious injury. An...
Nov 18, 2016
Patent protections for Software as a Medical Device are increasingly important due to the additional investments in clinical evaluation that may be needed to...