The recall, related to a manufacturing misstep for St. Jude's Optisure defibrillator leads, effects 447 devices and has not been linked to any patient injuries, the firm says.
FDA has designated a recent fault in St. Jude Medical Inc.'s manufacturing process for its Optisure defibrillation lead as a high-risk, class I recall action.
The recall
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A Johns Hopkins University study found publicly traded companies are responsible for 90% of recalled AI-powered medical devices. The study attributes this link to lower clinical validation, especially among smaller companies, and advocates for increased clinical trials to enhance device safety.
Despite a surge in product recalls across five key industries in the first quarter of the year, medical device recalls were down, according to Sedgwick’s latest recall index. But the firm noted they’ve since ticked up.
Draeger Medical has recalled certain SafeStar and TwinStar ventilation filters after reports of serious injuries caused by misleading carbon dioxide readings.
The US FDA issued a pair of early alerts on Wednesday warning customers about serious adverse events associated with two Boston Scientific cardiac devices. Both alerts include numerous reports of injuries and deaths and are part of the FDA’s ongoing pilot to enhance its recall process.
Despite a surge in product recalls across five key industries in the first quarter of the year, medical device recalls were down, according to Sedgwick’s latest recall index. But the firm noted they’ve since ticked up.
Signos links users to Dexcom’s Stelo for glucose readings and historic trends. The app is available in iOS and Android from the firm’s website, where it’s priced at $139 for three-month plan and $129 for a two-month plan, or online app stores.
IQWiG, Germany’s health technology assessment body, is making contingency plans in case key US resources it relies on for information retrieval, when conducting benefit assessments of new medicines, become unavailable.
