Medical device recalls, whether voluntary or mandated, are crucial for ensuring patient safety.
Here are three recent recalls reported to the FDA:
Phillips recalls monitoring service application for Mobile Cardiac Outpatient Telemetry
Phillips issued a recall for a subset of its Monitoring Service Application for Mobile Outpatient Telemetry due to a software issue that caused some ECG events to be improperly routed between July 2022 and July 2024. The failure may have resulted in missed notifications of critical arrhythmias like atrial fibrillation, ventricular tachycardia and second- or third-degree AV block, which could lead to delayed or untreated conditions, potentially causing serious injury or death.
The FDA has classified this recall as a Class I, the most serious type. Healthcare providers are advised to check affected patients and reprocess ECG data as necessary. There have been 109 injuries and two deaths related to this issue.
Getinge and Maquet Cardiovascular recall VasoView HemoPro 2 Endoscopic Vessel Harvesting Systems
Getinge and Maquet Cardiovascular issued a recall for the VasoView HemoPro 2 Endoscopic Vessel Harvesting Systems due to potential for bent or detached heater wires and silicone peeling or detaching from the jaws of the harvesting tool. These issues could cause significant risks including bleeding, burns, vessel blockage, infection or even death during endoscopic vessel harvesting.
The FDA has classified this as a Class I recall. Healthcare providers are advised to carefully inspect devices before use, monitor devices during use and stop using any damaged equipment immediately. There have been seven reported injuries and no deaths.
Fresenius Kabi USA recalls Ivenix Infusion Pump Software
Fresenius Kabi USA issued a recall for certain software versions of the Ivenix Infusion Pump due to anomalies that may result in underdosing or overinfusion of medication. During alarm conditions or when transitioning between primary and secondary infusions, the pump may malfunction, leading to either insufficient medication delivery or excessive infusion, both of which can result in serious patient harm, including arrhythmias, hyperglycemia and even death.
The FDA has issued an early alert for this issue and healthcare providers are advised to update the software to version 5.10 to mitigate the risks. No injuries or deaths have been reported.