The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product The LIFEPAK 15 Monitor/Defibrillator (LP15) Serial Numbers: See full list below Distribution Dates: September 13, 2014, to July 4, 2016 Manufacturing Dates: September 3, 2014 to June…
The FDA alerts health care providers about potential risks with fluid-filled intragastric balloons
February 9, 2017 Dear Health Care Provider, The FDA has recently received multiple reports for two different types of adverse events associated with fluid-filled intragastric balloons used to treat obesity. We recommend that you closely monitor patients with these devices for these adverse events, and to submit reports to help us better understand any complications…
Class I Medical Device Recall: CareFusion Recalls Alaris Syringe Pump due to an Alarm Error Which May Cause Interruption of Therapy
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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150035 and DEN140017 added)
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January 2017 PMA Approvals
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Chlorhexidine Gluconate: Drug Safety Communication
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Registry-Based Prospective, Active Surveillance of Medical-Device Safety
Abstract Background The process of assuring the safety of medical devices is constrained by reliance on voluntary reporting of adverse events. We evaluated a strategy of prospective, active surveillance of a national clinical registry to monitor the safety of an implantable vascular-closure device that had a suspected association with increased adverse events after percutaneous coronary…
Halo One Thin-Walled Guiding Sheath by Bard Peripheral Vascular Inc.: Class I Recall
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Class I Medical Device Recall: Bard Peripheral Vascular Inc. Recalls Halo One Thin-Walled Guiding Sheath Due to Sheath Separation, Kinking, or Tip Damage
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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150033 and DEN140024 added)
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