Tag: Product Recalls

Medtronic recalls TurboHawk Plus Directional Athrectomy System

Editor's Note On February 7, Medtronic announced that it had issued a voluntary recall of its 6Fr TurboHawk Plus Directional Atherectomy System because of the risk of tip damage caused by guidewire prolapse. To date, there have been no reports of tip damage and no reports of injuries or deaths…

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By: Judy Mathias
February 7, 2022
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FDA: Update on Class I recall of certain Philips Respironics ventilators, repair kits

Editor's Note The Food and Drug Administration (FDA) on January 26 updated the Class I recall of certain Trilogy Evo ventilators and repair kits for Trilogy Evo muffler assembly, which are manufactured by Philips Respironics. According to the update, the FDA has asked the company to have an independent laboratory…

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By: Judy Mathias
February 1, 2022
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FDA: Class I recall of Medtronic’s HawkOne Directional Atherectomy System

Editor's Note The Food and Drug Administration (FDA) on January 21 identified the recall by Medtronic Inc of its HawkOne Directional Atherectomy System as Class I, the most serious. The recall was initiated because of the risk of the guidewire within the catheter moving down ward or prolapsing when force…

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By: Judy Mathias
January 24, 2022
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FDA: Class I recall of Getinge Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems

Editor's Note The Food and Drug Administration (FDA) on January 19 identified the recall by Getinge of its Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems as Class I, the most serious. The recall was initiated because of the potential chemical breakdown of Sevoflurane that may result in inhalation…

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By: Judy Mathias
January 20, 2022
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FDA: Class I recall of Medtronic Synergy Cranial, StealthStation S7 cranial software

Editor's Note The Food and Drug Administration (FDA) on January 6 identified the recall by Medtronic of its Stealth Station System with Synergy Cranial and StealthStation S7 Cranial Software as Class I, the most serious. The System aids in precisely locating anatomical structures in neurosurgical procedures. The recall was initiated…

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By: Judy Mathias
January 18, 2022
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FDA: Class I recall of Cardiovascular Systems’ WIRION Embolic Protection Device

Editor's Note The Food and Drug Administration (FDA), on January 10, identified the recall of Cardiovascular Systems’ WIRION Embolic Protection Device as Class I, the most serious. The device, which is used to hold or remove debris or blood clots from the lower limbs, was recalled because of complaints of…

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By: Judy Mathias
January 11, 2022
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FDA: Class I recall of Puritan Bennett 980 Series Ventilator

Editor's Note The Food and Drug Administration (FDA), on January 3, identified the recall by Covidien of its Puritan Bennett 980 Series Ventilator as Class I, the most serious. The recall was initiated because of a capacitor manufacturing assembly error that may cause the ventilator to become inoperable or stop…

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By: Judy Mathias
January 5, 2022
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FDA: Class I recall of Getinge/Datascope/Maquet Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps

Editor's Note The Food and Drug Administration, on December 16, identified the recall by Getinge/Datascope/Maquet of its Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) as Class I, the most serious. The IABPs are cardiac assist devices used in patients having cardiac and noncardiac surgery and to treat patients…

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By: Judy Mathias
December 16, 2021
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FDA: Edge Pharma issues nationwide recall of all drug products

Editor's Note The Food and Drug Administration (FDA) on December 7 announced that Edge Pharma, LLC (Colchester, Vermont) has issued a nationwide recall of all drug products. The recall was initiated because of process issues that could lead to a lack of sterility assurance for products intended to be sterile…

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By: Judy Mathias
December 9, 2021
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FDA: Class I recall of Teleflex percutaneous thrombolytic device kit

Editor's Note The Food and Drug Administration (FDA), on November 30, identified the worldwide recall by Teleflex of its Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7FR as Class I, the most serious. The device, which is used for mechanical declotting of native arteriovenous fistulae and synthetic dialysis grafts, was…

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By: Judy Mathias
December 2, 2021
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