http://badmedicaldevicesblog.com Just another WordPress weblog Fri, 12 Mar 2010 20:22:04 +0000 http://backend.userland.com/rss092 en Companies that make surgical-ablation devices may have been violating the law by actively marketing them for non-FDA-approved uses. While doctors may use drugs or devices for off-label treatments, companies are allowed to market them only for the uses for which they have been FDA-approved. Though surgical-ablation devices aren't approved to treat A-fib, ... http://badmedicaldevicesblog.com/2010/03/12/surgical-ablation-device-companies-under-criticism/ The FDA has notified healthcare professionals of a Class I recall of Beckman Coulter’s UniCel DxC Synchron Clinical System – Ion Selective Electrode Flow Cell. These systems are computer-controlled chemistry analyzers used to determine blood and other chemistries from blood samples collected from an individual. There may be excessive build-up of ... http://badmedicaldevicesblog.com/2010/03/12/fda-issues-class-i-recall-of-beckman-coulter-device/ Abiomed Inc. has been forced to issue a Class I recall on its AB5000 Circulatory Support System because it could stop working without warning and lead to patient injury or death. The AB5000 is designed to provide power to disposable blood pumps used to operate the left and/or right sides of ... http://badmedicaldevicesblog.com/2010/03/12/abiomed-recalls-circulatory-pumps-due-to-injury-death-risk/ The Food and Drug Administration has issued a Class I recall on a heart sheath manufactured by Baylis Medical Company Inc. because its use could result in serious patient injury or death. According to a release from regulators, the tip of the Torflex Transseptal Guiding Sheath can break off during a ... http://badmedicaldevicesblog.com/2010/03/12/baylis-issues-class-i-recall-on-heart-sheaths-due-to-injury-death-risk/ Medtronic said it is the focus of a federal investigation looking into its relationship with doctors at a hospital in Massachusetts. According to an AP report, the medical device maker said in its regulatory filings that the investigation focuses on its CoreValve division. Medtronic, and other major medical device makers, are accused ... http://badmedicaldevicesblog.com/2010/03/12/medtronic-discloses-federal-investigation-over-relations-with-cardiologists/ DePuy Orthopaedics, a unit of Johnson & Johnson, has warned doctors that the ASR hip implant device appears to have a high early failure rate in some patients. The warning comes just months after saying it was phasing out metal-on-metal artificial hip implant ASR because of slowing sales. The action follows more ... http://badmedicaldevicesblog.com/2010/03/10/depuy-pulls-hip-implant-after-years-of-failure-studies/ Roex Inc. and the Federal Trade Commission have reached a settlement over claims the company made about its medical devices. Roex sold infrared saunas and dietary supplements through a radio infomercial, in print ads and on its Web site. The company and its two principles made false claims about the power ... http://badmedicaldevicesblog.com/2010/03/09/ftc-reaches-settlement-with-company-selling-infrared-saunas-as-therapy-for-terminal-disease/ Health officials are looking for ways to minimize risks from potentially dangerous malfunctions of insulin pumps used by tens of thousands of diabetics. Defective pumps can lead to high or low blood sugar if the machines fail to deliver the proper amount of insulin, which can be fatal. The FDA report did ... http://badmedicaldevicesblog.com/2010/03/04/fda-addresses-insulin-pump-problems/ Leading orthpaedic surgeons are expressing concern over metal-on-metal hip implants due to debris from the implanted device. In a New York Times report, surgeons at Rush University Medical Center in Chicago and the Mayo Clinic in Minnesota have expressed concern over the use of metal hip implant parts, used in about ... http://badmedicaldevicesblog.com/2010/03/04/metal-hip-devices-cause-problems-soon-after-surgery/ The Food and Drug Administration is classifying Baxter Healthcare Corp.'s latest recall as a Class I call-back, its most serious. According to a release from Baxter, the recall involves its HomeChoice and HomeChoice Pro peritoneal dialysis cyclers. Use of these medical devices could result in serious patient injuries or death. Should these ... http://badmedicaldevicesblog.com/2010/03/04/fda-issues-class-i-recall-on-dialysis-devices/