FDA Issues Alert for Heart Pump Controllers Due to Component Failures
Abiomed is replacing components in Automated Impella Controllers following reports of injuries and deaths linked to purge cassette recognition issues.
Category: Recalls
Recalls
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Recalls
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React Health Removes VOCSN V+Pro Ventilators
A manufacturing error may lead to undetected oxygen leaks, posing risks of reduced oxygen delivery and potential fire hazards.
Recalls
Latest
Fresenius Kabi Removes Ivenix Large-Volume PumpsÂ
A misassembly defect in a specific lot of Ivenix primary administration sets could cause reverse flow, delayed infusion, or serious patient harm, prompting a Class I recall.
Recalls
Latest
FDA Issues Alert for Heart Pump Controllers Due to Component Failures
Abiomed is replacing components in Automated Impella Controllers following reports of injuries and deaths linked to purge cassette recognition issues.
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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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.
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Recalls
Latest
Class I Recall Expanded for Alaris Pump Infusion Sets
The voluntary recall involves certain infusion sets used with the BD Alaris Pump Module model 8100 due to performance deviations that could impact dose accuracy.
