FDA designates Class I recall for neurosurgery software
Editor's Note The US Food & Drug Administration (FDA) has classified Medtronic’s recall of its StealthStation S8 software as a Class I, the most severe category indicating risk of serious injury or death. The StealthStation System with StealthStation Cranial software is intended as an aid for locating anatomical structures during…
Class 1 recall announced for ambulatory infusion pump
Editor's Note The US Food and Drug Administration (FDA) has designated OptumHealth Care Solutions’ recall of the Nimbus II ambulatory infusion pumps a class 1, the most severe category indicating risk of serious injury or death. According to the agency’s May 30 announcement, the company recalled the pumps in direct…
FDA announces Class 1 recall for Vyaire Medical’s Twin Tube CPX sample lines
Editor's Note A choking hazard prompted the US Food and Drug Administration (FDA) to designate Vyaire Medical’s recall of Twin Tube sample lines—critical components of the Vyntus CPX system—as Class 1, the most serious category of recall indicating a risk of serious injury or death. According to the agency’s May…
Supply chain stress fractures demand rock-solid continuity planning
More than 4 years after personal protective equipment production and inventories crashed amid the global COVID-19 pandemic, the “new normal” in healthcare supply chains seems to be “uncertainty.” Although hospital margins are improving and patient volumes are trending upward, “stress fractures continue to remain in place,” says Michael Schiller, CMRP,…
FDA announces class 1 recall for radiographic breast tissue marker
Editor's Note The US Food and Drug Administration (FDA) has designated the recall of Hologic Inc.’s BioZorb Marker a class 1, indicating a risk of serious injury or death. BioZorb is an implantable radiographic marker used to mark soft tissue (such as breast tissue) for future medical procedures. Provided sterile…
Heart pump recall, lack of donor organs create concern for heart failure patients
Editor's Note The lack of available hearts for transplantation combined with the recent recall of Abbott’s HeartMate 3 left ventricular assist device (LVAD) “makes the current therapy landscape for heart failure much more dire,” according to a May 20 report in Medical Device Network. The recall of the device, which…
FDA announces class 1 recalls for heart devices, ventilators
Editor's Note The US Food and Drug Administration (FDA) has classified recalls of Abbot’s HeartMate 3 Left Ventricular Assist System (LVAS) implant kits and Phillips Respironics' Trilogy Evo ventilators as class 1, the most serious category indicating risk of serious injury or death. Used while waiting for recovery, a transplant,…
FDA issues class 1 recall for medical catheters
Editor's Note The US Food and Drug Administration (FDA) has designated Route 92 Medical’s recall of products containing the Tenzing 7 delivery catheters as class 1, the most serious classification indicating risk of serious injury or death. The devices are used to deliver microcatheters to the blood vessels in the…
FDA warns of continued cardiac pump safety concerns after series of recalls
Editor's Note The US Food and Drug Administration (FDA) is urging healthcare providers to avoid using Getinge heart devices due to continued safety concerns that remain unaddressed despite previous recalls. Issued to healthcare providers May 8, the warning letter applies to Getinge/Maquet/Datascope Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pump (IABP) devices…
FDA medical device Class 1 recalls trend upward
Editor's Note The number of US Food and Drug Administration (FDA) Class 1 recalls—the most serious classification—for medical devices has been trending upwards. Regulatory News, a publication of the Regulatory Affairs Professional Society (RAPS), reported the news April 25. According to the report, Anne Reid, program director of the Office…
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