Editor's Note The Food and Drug Administration (FDA), on August 31, identified the recall by Getinge/Maquet/Datasocpe of its Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) as Class I, the most serious. The FDA posted four recalls for four separate reasons: Because they may overheat when the device’s internal temperature…

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Editor's Note The Food and Drug Administration (FDA), on August 30, identified the recall by Hamilton Medical of its HAMILTON-C1, C2, C3, and T1 ventilators as Class I, the most serious. The recall was initiated because of software issues that may cause the ventilators to stop without notice. There have…

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Editor's Note The Food and Drug Administration (FDA), on August 23, identified the recall by Draeger Medical of its Carina Sub-Acute Care Ventilators as Class I, the most serious. The recall was initiated because of the presence of contaminants in the device’s airpath. The contaminants exceed acceptable levels if the…

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Editor's Note The Food and Drug Administration (FDA), on August 17, identified the recall by Abiomed of the labeling for its Impella RP Flex with Smart Assist System Catheter as Class I, the most serious. The recall was initiated because the catheters’ instructions for use did not appropriately address precautions…

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Editor's Note The Food and Drug Administration (FDA), on August 14, identified the recall by Philips Respironics of its Trilogy Evo, Evo 02, EV300, and Evo Universal Ventilators as Class I, the most serious. The recall was initiated after detecting dust and dirt from the environment in the air path…

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Editor's Note The Food and Drug Administration (FDA), on August 10, identified the recall by Datascope/Maquet/Getinge of its Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) as Class I, the most serious. The recall was initiated because the pumps may shut down unexpectedly due to electrical failures in the Power…

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Editor's Note The Food and Drug Administration (FDA), on August 1, identified the recall by Baxter Healthcare Corporation of its SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) and Spectrum IQ Infusion System with Dose IQ Safety Software (Version 9) as Class I, the most serious. The recall…

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Editor's Note The Food and Drug Administration (FDA), on July 28, identified the recall by GE HealthCare of its TruSignal SpO2 [arterial oxygen saturation] sensors as Class I, the most serious. The recall was initiated because of issues that may reduce the amount of energy sent to the heart during…

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Editor's Note The Food and Drug Administration (FDA), on July 26, identified the recall by Abbott of its Amplatzer Steerable Delivery Sheath as Class I, the most serious. Abbott is recalling the sheath because of an increased risk for air emboli being introduced into patients who have cardiac catheterization procedures…

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Healthcare facilities face challenges in the recall process of tissue, non-biologic implants, and medical devices because of their time-sensitive nature and inherent risks to patient safety and compliance. Hospitals often use secondary sources for recall notifications. These lists, however, do not include two critical pieces—the identification of affected patient cases…

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