4/29/2014 FDA Medical Device Safety and Recalls:

GenStrip Blood Glucose Test Strips May Report False Results.   HeartWare, Inc., Heartware Ventricular Assist System.  Baxter Healthcare Corporation, Sigma Spectrum Infusion Pumps

Shasta Technologies GenStrip Blood Glucose Test Strips May Report False Results
Today the U.S. Food and Drug Administration issued a Safety Communication advising people with diabetes and health care professionals to stop using GenStrip Blood Glucose Test Strips because the strips may report incorrect blood glucose levels.  For more information, please see http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm395180.htm

Medical Device Safety and Recalls: HeartWare, Inc., Heartware Ventricular Assist System – Locking Mechanism of Pump Driveline Connector May Fail to Engage
04/29/2014
The U.S. Food and Drug Administration has issued a recall for the HeartWare Ventricular Assist System, which is used as a bridge to cardiac transplantation in patients who are at risk of death from advanced heart failure.  The company received reports where the driveline connector locking mechanism has failed to engage as a result of a faulty manufacturing assembly process. This failure could result in the pump stopping and potentially lead to serious adverse health consequences, including death.  For more information, please see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm395252.htm

Medical Device Safety and Recalls: Baxter Healthcare Corporation, Sigma Spectrum Infusion Pumps with Master Drug Library Model No. 35700BAX and 35700ABB
05/01/2014
A recall has been issued for the Baxter Healthcare Corporation Sigma Spectrum Infusion Pumps with Master Drug Library Model No. 35700BAX and 35700ABB.  Baxter has received over 3500 reports of System Error 322 “Link Switch Error (low)” incidents in which the device has malfunctioned, including nine severe adverse events and no deaths.  The System Error 322 occurs when the pump improperly detects that the door is open when it is physically closed.  A System Error 322 may lead to an interruption or delay in therapy.  For more information, please see http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm395617.htm