FDA issues Class I alert for Abiomed Impella heart device over cybersecurity risks
Editor's Note The Food and Drug Administration (FDA) on October 10 classified a cybersecurity correction involving Abiomed’s Automated Impella Controller as a Class I recall, the most serious type, according to the FDA Medical Device Recalls and Early Alerts database. While devices are not being removed from clinical settings, the…
FDA accelerates medical device safety alerts to reach public within days
Editor's Note The Food and Drug Administration (FDA) has expanded its early alert recall program to include all medical devices, speeding up how quickly the public learns about high-risk safety issues, Modern Healthcare October 9 reports. The initiative allows the FDA to post early alerts within days of manufacturers notifying…
FDA posts four device safety communications, prompting inventory, workflow checks
Editor's Note The Food and Drug Administration (FDA) has issued four medical device recalls and early alerts between September 23 and 30, covering Automated Impella Controllers, Olympus ViziShot 2 FLEX (19G) endoscopic aspiration needles, 3M Ranger blood and irrigation fluid warming systems, and BD Alaris infusion pump sets. The notices…
FDA flags device recalls while clearing new technologies for surgery, critical care
Editor's Note The Food and Drug Administration (FDA) has issued multiple high-risk medical device recalls in recent weeks, mid-September FDA announcements report. On August 21, Medline alerted customers that some of its convenience kits contain recalled Medtronic DLP Left Heart Vent Catheters. These catheters, used in cardiopulmonary bypass, may fail…
FDA issues early alerts on multiple high-risk device recalls from J&J, Medtronic, Baxter, Boston Scientific
Editor's Note The Food and Drug Administration (FDA) has issued a series of early alerts this month regarding high-risk recalls from several leading medical device makers, citing patient safety risks ranging from pump failures to vascular complications. These alerts highlight issues with products from Johnson & Johnson’s (J&J’s) Abiomed unit,…
FDA announces Class 1 recall for Draeger breathing filters
Editor's Note The FDA has issued a Class 1 recall—the most severe category indicating risk of serious injury or death—for Draeger Filter SafeStar 90 Plus (MP05785), Filter SafeStar 55 Plus (MP05790), Filter SafeStar 60A Plus (MP05795), and Filter/HME TwinStar HEPA Plus (MP05801) breathing system filters, affecting all lot numbers. Draeger…
FDA issues Class I recall for Philips BiPAP ventilators
Editor's Note Philips Respironics BiPAP A30, A40, and V30 Auto ventilators are subject to a Class 1 recall—the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or death—due to the risk for a failure in the Ventilator Inoperative alarm, which can cause therapy interruption…
FDA designates Class I recall for disposable surgical stapler cartridge correction
Editor's Note The US Food and Drug Administration (FDA) has designated the recall of Ethicon Endo-Surgery, LLC’s Endopath Echelon Vascular White Reload for Advanced Placement Tip a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 25 announcement, the recall…
FDA designates Class I recall for arterial cannulae due to exposed wire risk
Editor's Note The US Food and Drug Administration (FDA) has designated a Class I recall—the most severe category indicating risk of serious injury or death—for several models of arterial cannulae manufactured by Edwards Lifesciences. Affected products include OptiSite Arterial Perfusion Cannula models OPTI16 and OPTI18, as well as Peripheral Femoral…
FDA designates Class I recall for mobile lift component
Editor's Note The US Food and Drug Administration (FDA) has designated Baxter’s recall of the Q-Link 13 mobile lift component a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 23 announcement, the optional component connects to sling bars on…
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