Tag: FDA

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…

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By: Matt Danford
April 29, 2024
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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…

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By: Matt Danford
April 26, 2024
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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…

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By: Matt Danford
April 25, 2024
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Gene-edited pig kidney, heart pump combined in transplant surgery milestone

Editor's Note The second-ever living recipient of a gene-edited pig kidney was the first to have the new organ paired with a mechanical heart pump, according to an April 24 CNN report. The subject, 54-year-old Lisa Pisano, underwent the milestone surgery at NYU Langone Health. She had heart failure and…

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By: Matt Danford
April 25, 2024
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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…

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By: Matt Danford
April 24, 2024
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FDA approves imaging drug for detecting cancer after lumpectomy

Editor's Note The US Food and Drug Administration (FDA) approved Lumisight (pegulicianine), a fluorescent imaging drug used to detect cancerous tissue during lumpectomy, on April 17. Administered intravenously prior to surgery, Lumisight is designed for use with the Lumicell Direct Visualization System (DVS) or another imaging device that is FDA-approved…

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By: Matt Danford
April 22, 2024
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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…

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By: Matt Danford
April 18, 2024
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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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By: Matt Danford
April 17, 2024
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FDA: Surgical mesh mini-slings comparable to mid-urethral slings for stress urinary incontinence

Editor's Note Mini-slings for stress urinary incontinence (SUI) are similarly effective to mid-urethral slings over a 36-month timeframe, according to an April 11 announcement from the US Food & Drug Administration (FDA). FDA reached this conclusion after an in-depth, systematic literature review of post-market surveillance (“522”) studies required last year…

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By: Matt Danford
April 15, 2024
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Newly FDA-approved microsurgical system holds promise for training, new treatments

Editor's Note The US Food & Drug Administration (FDA) has granted De Novo authorization for marketing MMI North America Inc.’s Symani Surgical System, according to the agency’s April 9 roundup. The system employs a motion scaling function to scale down surgeons movements for procedures requiring small instruments and/or microscopes, such…

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By: Matt Danford
April 10, 2024
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