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…
FDA announces class 1 recall for disposable biopsy needle kit
Editor's Note Microscopic stainless steel debris on the insides of biopsy needles prompted the FDA to issue a class 1 recall—indicating risk of death or serious injury—for Elekta Instrument’s Disposable Biopsy Needle Kit, which is used with the Leksell Stereotactic System for brain tissue sampling during neurosurgery, the disposable biopsy…
FDA announces class 1 recalls for infusion pumps, anesthesia workstation
Editor's Note Reports of spontaneous backup battery failure in Dreager Inc.’s Perseus A500 anesthesia workstation and multiple failures in InfuTronix, LLC’s Nimbus infusion pump systems prompted the FDA to classify manufacturer recalls as class 1, the most serious categorization indicating risk of serious harm or death. According to an April…
Joint replacement manufacturer recalls products after FDA packaging warning
Editor's Note A January complaint about inefficient packaging for joint replacement products has prompted the manufacturer to recall certain knee and shoulder system devices after initially declining to take the products off the market, according to an April 23 report in Health Exec. The manufacturer, Exactech, is now recalling a…
Catheter sterility concerns prompt Class 1 FDA recall for surgery trays
Editor's Note The US Food and Drug Administration has designated DeRoyal Industries’ recall of GeoMed custom tracecarts a class 1, the most serious type of recall indicating a risk of serious injury or death. According to the April 24 FDA notice, the recall is due to sterility concerns with the…
FDA announces class 1 recalls for premixed embolic, infusion pump software
Editor's Note The US Food and Drug Administration has classified recalls of Boston Scientific’s Obsidio Conformable Embolic and Fresenius Kabi USA’s Ivenix Infusion System Large Volume Pump (LVP) software as class 1, the most serious category and an indicator of risk of serious injury or death. No injuries or deaths…
FDA Class 1 recall renews concern about historically problematic heart pumps
The US Food & Drug Administration (FDA) announced a Class 1 recall on Monday for Abbott/Thoratec Corp.’s HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS) due due to biological material buildup obstructing the devices. According to an April 16 CBS News report, surgeons first noticed problems with the…
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