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 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…
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 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…
FDA recalls BrightView SPECT systems
Editor's Note The FDA has issued a Class I recall of Philips’ BrightView, BrightView X and BrightView XCT Single Photon Emission Computed Tomography (SPECT) scanners due to a component failure that could result in the system’s detector falling on patients. Philips sent all affected customers an Urgent Medical Device Correction…
FDA announces urgent chest drain recall
Editor's Note The FDA has announced a recall of the Atrium Express Dry Suction Dry Seal Chest Drain, a disposable device used to remove air and/or fluid from the chest cavity or mediastinum and to aid in lung expansion and breathing. The drain is being recalled by maker Maquet Cardiovascular,…
FDA: Class I recall of Mallinckrodt One-Way Valve, 22F x 22M
Editor's Note The Food and Drug Administration (FDA), on September 12, identified the recall by Mallinckrodt Manufacturing of its One-Way Valve, 22F x 22M, as Class I, the most serious. The recall was issued because the devices are not opening properly, which prevents or reduces the flow of ventilated air…
FDA: Class I recall of Cardiosave Hybrid, Rescue IABPs
Editor's Note The Food and Drug Administration (FDA), on August 31, identified the recall by Getinge/Maquet/Datasocpe of its Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps (IABPs) as Class I, the most serious. The FDA posted four recalls for four separate reasons: Because they may overheat when the device’s internal temperature…
FDA: Class I recall of certain Hamilton ventilators
Editor's Note The Food and Drug Administration (FDA), on August 30, identified the recall by Hamilton Medical of its HAMILTON-C1, C2, C3, and T1 ventilators as Class I, the most serious. The recall was initiated because of software issues that may cause the ventilators to stop without notice. There have…
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