FDA Issues Alert for Medtronic Esophageal Monitoring Devices
The agency warns of potential high-risk issues with Bravo CF delivery systems following reports of 184 serious injuries.
Category: Recalls
Recalls
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Recalls
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FDA Recall Issued for Ivenix Infusion Pump Software Due to Shutdown Risk
The company is advising users to keep devices plugged into AC power following a software anomaly that may cause false battery readings and unexpected shutdowns.
Recalls
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GAO Report Finds FDA Struggles to Meet Medical Device Recall Termination Goals
The agency exceeded its three-month termination timeline for 74% of recalls during fiscal years 2020-2024, due to staff constraints that limited oversight activities, the report finds.
Recalls
Latest
FDA Issues Alert for Medtronic Esophageal Monitoring Devices
The agency warns of potential high-risk issues with Bravo CF delivery systems following reports of 184 serious injuries.
GE HeathCare Recalls Carestation Anesthesia Systems Due to Shutdown Risk
GE HealthCare is updating use instructions after reports certain systems may not switch to battery mode during AC power loss, potentially disrupting ventilation and agent delivery.
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Baxter Permanently Removes Life2000 Ventilation System Due to Cybersecurity Issue
The company is pulling the Life2000 system from the market after finding a vulnerability that could allow unauthorized changes to ventilation settings.
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NOxBOXi Delivery System Correction Issued After Reports of Nitric Oxide Dose Fluctuations
The FDA issued a safety alert after users reported nitric oxide dose fluctuations, potentially leading to hypoxemia or increased pulmonary artery pressure.Â
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Siemens Healthineers Corrects 3 Tesla MRI Systems Over Magnet Venting Blockage Risk
The issue affects certain systems in which ice may obstruct the venting system, potentially leading to dangerous overpressure events if a magnet quench occurs.
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FDA Issues Recall Alert for B Braun Medical Hemodialysis Blood Tubing Set
The alert follows reports of damaged patient connectors that could introduce micro-air bubbles, trigger air-in-line alarms, and lead to treatment delays or blood loss during hemodialysis.
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3M Company Corrects Ranger Blood/Fluid Warming System
The action addresses a discrepancy between the device’s labeled and actual performance at high flow rates, which could pose a risk of patient hypothermia.
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Recalls
Latest
FDA Alerts Users to Purge Pressure Issues in Automated Impella Controller
The alert links purge retainer failures to potential pump stops and loss of hemodynamic support; the manufacturer is planning a service update.
