Burns prompt recalls of airway scopes, electrosurgical pads
Editor's Note Reports of burn injuries have prompted two medical device recalls: one for Megadyne patient return electrodes and one for Olympus bronchofiberscopes and bronchovideoscopes. According to a December 21 notice from AORN, the former recall is a voluntary correction on the part of Megadyne Medical Products, Inc. Following reports…
First hospital joins FDA’s medical device information sharing and analysis initiative
Editor’s Note Charlotte, North Carolina-based Atrium Health is the first hospital to join the Medical Device Information Analysis and Sharing (MDIAS) public-private partnership (PPP) between the Food and Drug Administration (FDA) and private sector stakeholders. The news was announced December 12 by Mitre, a nonprofit research organization and the independent…
FDA: Class I recall of Medtronic implantable cardioverter, cardiac resynchronization therapy defibrillators
Editor's Note The Food and Drug Administration (FDA), on July 18, identified the recall by Medtronic of its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) as Class I, the most serious. Medtronic is recalling all ICDs and CRT-Ds, with glassed feedthroughs that were manufactured after 2017, as…
Study: Unsafe medical devices gain FDA approval through loophole
Editor's Note A study done by investigators from Yale, Harvard, and the University of California-San Francisco, published on January 10 in JAMA, found that “many medical devices subject to recall had received Food and Drug Administration (FDA) approval based, in part, on the products’ similarities to earlier devices,” Healthcare Purchasing…
FDA: Class I recall of Datascope/Getinge Cardiosave Hybrid, Rescue IABPs
Editor's Note The Food and Drug Administration (FDA) on January 25 identified the recall by Datascope/Gettinge of its Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps (IABPs) as Class I, the most serious. The recall was initiated because of the risk that blood may enter the pump through a damaged balloon…
FDA: Class I recall of Insulet Omnipod DASH PDM
Editor's Note The Food and Drug Administration (FDA) on November 16 identified the recall by Insulet of its Omnipod DASH Insulin Management System Personal Diabetes Manager (PDM) as Class I, the most serious. The recall was initiated because of PDM battery issues, including: Battery swelling Fluid leakage from the battery…
FDA alerts patients, providers of Philips Respironics masks recall
Editor's Note The Food and Drug Administration (FDA) issued a safety communication alert on September 6 informing patients, caregivers, and healthcare providers that Philips Respironics (Philips) has recalled certain masks used with bilevel positive airway pressure (Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP) machines due…
FDA: Class I recall of Medtronic Cobalt/Crome ICDs, CRT-Ds
Editor's Note The Food and Drug Administration (FDA) on August 19 identified the recall by Medtronic of its Cobalt XT, Cobalt, and Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) as Class I, the most serious. The devices are being recalled because of reports of short circuit-protection…
FDA: Class I recall of certain Accula SARS-CoV-2 Tests
Editor's Note The Food and Drug Administration (FDA) on May 9 identified the recall by Mesa Biotech, Inc, of certain Accula SARS-CoV-2 Tests as Class I, the most serious. The recall was initiated because certain lots of the PCR test have an increased risk of giving false positive results because…
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